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Abstract of thesis entitled
“An Evidence-based Parent-directed Education Program in Increasing
Knowledge and Utilization of Pain Management During
Childhood Immunization”
Submitted by
Lam Yuk Pui
For the degree of Master of Nursing
at The University of Hong Kong
in July 2016
Immunization is one of the most effective ways in preventing infectious diseases.
However, the immunization-induced pain lead to distress in children, parents and health
care providers. Through scientifically proven pain management are available, they are
seldom used by parents. Therefore, it is essential to develop an evidence-based
guideline for increasing parents’ knowledge and utilization of the scientifically proven
pain management during childhood immunization.
The objectives of this study are to systematically review the current literatures on the
effectiveness of education program in increasing knowledge and utilization of pain
management of parents of the children under six years old. Data from the selected
studies are extracted for establishing table of evidence. Moreover, quality assessment
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of the selected articles is performed. An evidence-based guideline of parent-directed
education program is developed and its feasibility and transferability to the target
setting and clients is determined.
In this study, parent-directed education program is proposed. The target setting is one
of the Maternal and Child Health Centres in Hong Kong and the target clients are
parents of children under six years old. Data are extracted from 5 articles. The
implementation potential of the proposed guideline is high because of its transferability,
feasibility and cost-effectiveness. Based on the evidence, an evidence-based practice
guideline is developed to increase the knowledge and use of scientifically proven pain
management by parents. In order to improve the quality of life of both children and
parents and the quality of the service, it is recommended to establish the practice to all
Maternal and Child Health Centres.
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An Evidence-based Parent-directed Education Program in Increasing
Knowledge and Utilization of Pain Management During
Childhood Immunization
by
Lam Yuk Pui
BSc(Hons) NURS, R.N.
A dissertation submitted in partial fulfillment of the requirements for
the Degree of Master of Nursing
at The University of Hong Kong
July 2016
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Declaration
I declare that this thesis thereof represents my own work, except where due
acknowledgement is made, and that it has not been previously included in a thesis,
dissertation or report submitted to this University or to any other institution for a degree,
diploma or other qualifications.
Signed
Lam Yuk Pui
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Acknowledgements
I would like to express my sincere gratitude to my supervisor, Dr. Athena Hong
Wai Lin, for her guidance and advice on my thesis. Besides, I cannot forget my dear
groupmates who accompanied me with great support in the process.
In addition, I offer my heartfelt blessings to my family, especially my beloved
husband, for their sincere support, selfless love and understanding which assist me in
passing through the obstacles throughout the period of my study. I would like to share
the honour with them.
At last, I would like to take this opportunity to thank Department of Health for
offering me the sponsorship to accomplish the Master Degree in The University of
Hong Kong.
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Table of Contents
Declaration i
Acknowledgement ii
Table of Contents iii
List of Appendices v
Abbreviations vi
Chapter 1: Introduction 1
1.1 Background 1
1.2 Affirming the Needs 2
1.3 Objectives and Significance 4
1.3.1 Objectives 4
1.3.2 PICO components 5
1.3.3 Significance 5
Chapter 2: Critical Appraisal 6
2.1 Search and Appraisal Strategies 6
2.1.1 Electronic databases and keywords for searching 6
2.1.2 Selection criteria 7
2.1.3 Appraisal strategies 8
2.2 Results 8
2.2.1 Report of the search results 8
2.2.2 Summary of the data extracted 9
2.2.3 Summary of the appraisal results 11
2.3 Summary and Synthesis 14
2.3.1 Summary of data 14
2.3.2 Synthesis 16
2.3.3 Implication for practice 18
Chapter 3: Implementation Potential and Clinical Guideline 19
3.1 Transferability 19
3.1.1 Target setting 19
3.1.2 Target audience 20
3.1.3 Similarity of the setting between the identified studies and the
target setting
20
3.1.4 Philosophy of care 21
3.1.5 Similarity of characteristic of population between the identified
studies and the target setting
22
3.1.6 Number of clients benefited from the innovation 22
3.1.7 Length of time for implementation and evaluation 22
3.2 Feasibility 23
3.2.1 Organizational climate and administrative support 23
3.2.2 Consensus and friction among nurses 24
3.2.3 Interference to current practice 24
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3.2.4 Availability of resources and equipment 25
3.2.5 Evaluation tool 26
3.3 Cost-Benefit Ratio 27
3.3.1 Potential risk of the innovation 27
3.3.2 Potential benefits resulted from the innovation 27
3.3.3 Risk and cost of maintaining current practice 28
3.3.4 Cost of the innovation 29
3.3.5 Cost of not implementing the innovation 29
3.4 Evidence-Based Practice Guideline 30
Chapter 4: Implementation Plan 31
4.1 Communication Plan 31
4.1.1 The stakeholders 31
4.1.2 The process of communication 32
4.2 Pilot Study Plan 34
4.3 Evaluation Plan 36
4.3.1 Outcomes to be achieved 36
4.3.2 Nature and number of clients involved 38
4.3.3 Time to take measurement 39
4.3.4 Data analysis 39
4.4 Basis for Implementation 40
Chapter 5: Conclusion 42
Appendices 44
Reference 66
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List of Appendices
A. Hong Kong Childhood Immunization Programme 44
B. Levels of Evidence 45
C. PRISMA 2009 Flow Diagram 46
D. Table of Evidence 47
E. Checklist of SIGN 49
F. Time Schedule for Implementation Process of the Innovation 54
G. Content of the Pamphlet and Video 55
H. Cost of the Innovation 56
I. Cost of Not implementing the Innovation 57
J. Grades of Recommendations 58
K. Evidence-based Practice Guideline 59
L. Knowledge Test 62
M. Observation Form of Parental use of Scientifically Proven Pain
Management during childhood immunization
63
N. Self-developed Satisfactory Questionnaire 64
O. Outline of the Semi-structured Meeting 65
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Abbreviations
Chief Nursing Officer (CNO)
Department of Health (DH)
Family Health Service (FHS)
Intention-to-treat (ITT)
Maternal and Child Health Centres (MCHCs)
Nursing Officer (NO)
Nursing Officer In-charge (NOIC)
Principle Nursing Officer (PNO)
Randomised controlled trial (RCT)
Scottish Intercollegiate Guidelines Network (SIGN)
Senior Nursing Officer (SNO)
Vaccine-preventable diseases (VPDs)
World Health Organization (WHO)
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Chapter 1: Introduction
1.1 Background
Immunization is the core health intervention of controlling, reducing and eliminating
infectious diseases. According to World Health Organization (WHO) (2013),
immunization protects children from the threat of vaccine-preventable diseases
(VPDs). It is estimated that deaths caused by traditional VPDs has fallen from 0.9
million in 2000 to 0.4 million in 2010. Thus, vaccinated children have the chance to
survive and a better opportunity of developing their full potentials in the future. The
ultimate goal of immunization is all people in every part of the world are free from
VPDs (WHO, 2013).
According to the Department of Health (DH) (2015), the number of notifications of
VPDs remains low in Hong Kong. This success, especially in preventing VPDs in
infants and children, is achieved by the Maternal and Child Health Centres (MCHCs)
under the Family Health Service (FHS) of DH. The MCHCs administer the
vaccination according to the Hong Kong Childhood Immunisation Programme
(Appendix A), which is updated based on scientific advice, for children below six
years of age (FHS, 2013). The programme nowadays protects infants and children
from eleven communicable diseases, including tuberculosis, hepatitis B, diphtheria,
tetanus, pertussis, poliomyelitis, pneumococcal infection, varicella, measles, mumps
and rubella (FHS, 2014). The Child Health Survey revealed 93.6% of children aged 0
to 14 had been vaccinated according to the recommended schedule with the majority
of vaccinated children attend the public sector for immunization between 2005 and
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2006 (Centre for Health Protection, 2010). Approximately six hundred thousand
vaccines were administered in MCHCs, the coverage of vaccination under the
immunization programme is highly satisfactory (FHS, 2013).
In order to maintain the satisfactory immunization coverage, children need to receive
at least 14 shots of vaccine under the age of six, some children may need to receive
more vaccines due to their own physical condition. They may also receive more than
one shot during a single visit.
Through immunization is a powerful medicine in protecting people from
communicable disease, immunization-induced pain reduces immunization adherence
(Taddio et al., 2009). Abundant researches have been done finding ways of reducing
pain during immunization, especially for infants and children as their untreated
procedural pain leads to distress to them, their parents and health care providers
(Taddio et al., 2009; Wallace et al, 2014). Although scientifically proven pain
management is available, they are seldom used.
1.2 Affirming the Needs
The untreated pain experienced by children during medical procedure reduces their
level of cooperation, causing difficulty in carrying out the treatment and is associated
with more negative memories leading to fear at future procedure or needle phobia
(Taddio et al, 2009). Parents and health care providers also showed concern regarding
the potential of pain during vaccination (Wallace et al., 2014). Research determining
parents’ and physicians’ opinions about the administration of multiple childhood
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vaccination at a single visit, it is found that immunization-induced pain is the most
frequently expressed and main concern by both parties (Woodin et al., 1995). All
mothers are distressed during children immunization (Parvez et al., 2010). Concern
about the unrelieved pain during vaccination is an important factor for nonadherence
to immunization schedule as parents do not want their children suffer from pain or all
injections to be given at a time (Taddion et al., 2009). Nonadherence to immunization
schedule not only puts the children at risk, it also diminishes herd immunity and
results in reviving of infectious diseases (Primary Care Office, 2015; Taddio et al.,
2009).
The above phenome are observed in MCHCs. Children are anxious during
immunization. They struggle throughout the procedure. Parents are also anxious
during the process and do not cooperate with the injection nurses which may even
lead to conflict between them. Multiple injections during a single visit also increases
stress of nurses.
The primary reason for parents do not managing immunization-induced pain for their
children is knowledge deficient regarding the scientifically proven pain management
(Parvez et al, 2010; Taddio et al., 2007; Taddio et al., 2009). The cause of this
situation is that health care providers do not advise parents about the immediate pain
relief measures but focus on educating parents regarding the adverse reactions that
develop later (Taddio et al., 2009). The same situation is observed in the public sector
in Hong Kong. Nurses at MCHCs put lots of effort in educating parents and
caregivers about the reaction, side effect and aftercare of immunization. Interventions
of mitigating the immediate immunization-induced pain are not mentioned as there is
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no specific guideline or instruction in tackling the issue.
WHO Regional Office for Easter Mediterranean (2013) defined health education as
educational, motivational skill-building and consciousness-raising techniques which
enhances an individual capacity to make appropriate decisions regarding health. Thus,
health education directed to parents regarding mitigating pain of their children during
immunization equips them capacity to make appropriate decision in the pain relief
measures to be used and to improve the quality of life of both parents and children.
Since there is no educational intervention regarding pain management strategy for
immunization-induced pain of children available in current practice in MCHCs, it is
essential to put effort in developing an evidence-based guideline regarding the issue.
There are researches show that parent-directed education program increases parents’
knowledge and utilization of the scientifically proven pain management during
childhood immunization. However, there is no systematic review on this area.
Therefore, it is essential to collect and evaluate the existing researches to determine
the effectiveness and feasibility of implementing an evidence-based parent-directed
education program regarding pain management for infants and children in MCHCs in
order to improve the service.
1.3 Objectives and Significance
1.3.1 Objectives
- To review current literatures on education program directed to parents regarding
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pain management during childhood immunization in increasing knowledge and
utilization of pain management systematically
- To determine the implementation potential of a parent-directed education program
in MCHCs
- To develop an evidence-based practice guideline based on the identified evidence
1.3.2 PICO components
The target population of the innovation are parents or caregivers of children aged one
month to six years old undergoing routine immunization in MCHC. The intervention
is to offer evidence-based education program, including administrating pamphlet and
showing video, to the target population before routine immunization. Compared to
current practice with no intervention, the outcomes are to increase parents’ knowledge
and utilization of pain management during childhood immunization.
1.3.3 Significance
Teaching parents scientifically proven pain management promotes children, as well as
parents, the ability to cope with painful situation and reduces their sense of
helplessness (Schechter et al., 2007). Parents are willing to learn and use the pain
management to minimise pain in their children during immunization (Parvez et al.,
2010; Taddio et al., 2007). The proposed innovation can improve the quality of the
parents and children as they can transfer the learnt pain management to other clinical
setting in the future (Taddio et al., 2014b). It also helps improving client and health
care provider relationship.
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Chapter 2: Critical Appraisal
After affirming the needs, setting the objectives and emphasising the significance of
the proposed innovation, the search and appraisal strategies together with summary
and synthesis of results will be discussed in this chapter.
2.1 Search and Appraisal Strategies
To search for studies relevant for critical appraisal, electronic databases for searching
were identified. Besides, the keywords used for locating relevant studies were
developed and criterias for study selection were set up.
2.1.1 Electronic databases and keywords for searching
Three electronic databases, including British Nursing Index, ISI Web of Science and
PubMed, were used for searching relevant studies. Eligible studies for critical
appraisal were located by the following five sets of keywords:
1) “Parents” or “Caregivers”
2) “Immunization” or “Vaccination” or “Injection”
3) “Education” or “Teaching” or “Learning” or “Patient education handout” or
“Video-audio media”
4) “Infants” or “Newborn” or “Preschool children”
5) “Pain” or “Pain management”
Each set of keywords was searched independently without and restriction or limitation
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first. The results of each set of the keywords were combined to search in order to
minimise missing of any relevant studies. Reference lists of selected studies were
screened manually so to identify additional studies for critical appraisal.
2.1.2 Selection criteria
Inclusion and exclusion criteria were set to find out the most relevant articles for
critical appraisal.
Studies met the following criteria were included for critical appraisal:
1. Target group of the study was parents or caregivers of health children under six
years of age undergoing immunization.
2. Method for vaccination was injection.
3. Intervention was related to any form of health education intervention.
4. Outcome measures were level of knowledge and/ or utilization of scientifically
proven pain management.
Studies met the following criteria were excluded from the critical appraisal:
1. Target group of the study was parents or caregivers of preterm children or children
with congenital illness.
2. Not evaluating the effectiveness of any form of educational intervention of
teaching pain management regarding immunization.
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2.1.3 Appraisal strategies
Data from the relevant studies were extracted and tabulated in the table of evidence
for easy comparison among the studies. The quality of the selected studies were then
critically assessed as suggested by Scottish Intercollegiate Guidelines Network
(SIGN) (2014). The SIGN Methodology Checklist 2: Controlled Trials was used to
assess the internal validity as well as the overall assessment of the study with grading
assigned according to how well the study was done (SIGN, 2012). Strength of the
selected studies were graded according to the level of evidences recommended by
SIGN (2014) (Appendix B).
2.2 Results
2.2.1 Report of the search result
Eligible studies were searched between 21 November, 2015 and 9 December, 2015 by
three electronic databases including British Nursing Index, ISI Web of Science and
PubMed. A total of 55 citations were generated by using a combination of the five sets
of keywords described previously. After removing duplicated studies from the search,
44 citations remained for further screening. After screening the titles and abstracts of
the citations, 38 of them were excluded due to the studies not related to childhood
immunization, parents’ education and pain management. The remaining 6 studies
were assessed thoroughly by reading the full text. One of them were excluded as the
article was testing the usability of an educational pamphlet and video about infant
immunization pain management not evaluating the effectiveness of the educational
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intervention. Manual searches of the reference lists of the eligible studies for
identifying additional studies were performed. However, no additional studies were
found. Thus, a total of five studies were selected for critical appraisal. The PRISMA
Flow Diagram (Moher, Liberati, Tetzlaff, Altman & The PRISMA Group, 2009) in
Appendix C summarised the systematic search result.
2.2.2 Summary of the data extracted
The study design, quality of the study, sample characteristics, details of the
intervention and control, outcome measures and effect size of the five identified
studies were extracted and presented in a table of evidence for easy comparison.
Appendix D shows the complete table of evidence.
Nature of studies
All these five identified studies were written in English. Four of them used the design
of randomised controlled trial (Bustos, Jaaniste, Salmon & Champion, 2008; Cohen et
al., 2015; Taddio et al., 2014b; Taddio et al., 2015), while one used the design of
controlled trial without randomisation (Taddio, et al., 2014a).
Three of them were conducted in a single centre (Bustos, Jaaniste, Salmon &
Champion, 2008; Cohen et al., 2015; Taddio et at., 2014b) whereas two were
conducted in multiple centres (Taddio et al., 2014a; Taddio et al., 2015). The studies
were published between 2008 and 2015. All the studies were carried out in western
countries, including Australia (Bustos et al., 2008), the United States of America
(Cohen et al., 2015) and Canada (Taddio et al., 2014a; Taddio et al., 2014c; Taddio et
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al., 2015).
Sample characteristics
Parents of healthy children below six years of age undergoing immunization who also
met the inclusion and exclusion criteria of the studies were recruited. The sample
sizes of the five identified studies ranged from 60 to 440 with total 842 subjects
involved. The mean age of subjects ranged from 30 years old to 38 years old with the
majority of subjects were female.
Bustos et al. (2008), Cohen et al. (2015) and Taddio et al. (2015) recruited subjects in
the clinic setting while Taddio et al. (2014a) and Taddio et al. (2014c) recruited their
subjects in the hospital setting.
Characteristics of Intervention Group
Bustos et al. (2008), Taddio et al. (2014a) and Taddio et al. (2014c) provided printed
materials to subject while Cohen et al. (2015) showed the animation. Taddio et al.
(2015) combined both printed materials and video as the intervention.
Three studies did not have time limit for the intervention (Bustos et al., 2008; Taddio
et al., 2014a; Taddio et al., 2015) while the other two limited the time for intervention
to around 10 minutes (Cohen et al., 2015;Taddio et al.,2014c).
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Characteristics of controlled group
The control group of four of the studies were standard care as usual practice (Bustos
et al., 2008; Cohen et al., 2015; Taddio et al., 2014a; Taddio et al., 2015) while the one
conducted by Taddio et al. (2014c) used factsheet on normal growth substituted the
intervention.
Outcome measure
Level of knowledge and utilization of pain management were used as outcome
indicators in the identified studies. Cohen et al. (2015), Taddio et al. (2014a) and
Taddio et al. (2014c) used knowledge test to assess participants’ level of knowledge.
Bustos et al. (2008), Cohen et al. (2015) and Taddio et al. (2015) measured the use of
pain management by observation while Taddio et al. (2014a) and Taddio et al. (2014c)
relied on self-report of the pain management strategies used.
Effect size
The difference between intervention group and control group with p value <0.05
regards as significant difference
2.2.3. Summary of the appraisal results
The internal validity and overall quality of the studies were assessed by the SIGN
Methodology Checklist for Controlled Trials (2012) which were presented in
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Appendix E.
All the identified studies had appropriate and clearly focused question. Four of the
identified studies randomly assigned subjects to treatment or control groups by
computer generated random numbers table (Bustos et al., 2008; Cohen et al., 2015;
Taddio et al., 2014c; Taddio et al., 2015) while one study allocated subject to
treatment group without randomisation (Taddio et al., 2014a).
Allocation concealment methods were mentioned in three of the identified studies.
Allocation of participants of the study by Cohen et al. (2015) remained concealed in a
binder. Taddio et al. (2014c) used sequentially numbered opaque sealed envelopes as
concealment method. The study by Taddio et al. (2015) was a cluster randomised
controlled trail (RCT). No concealment method was used in the study by Taddio et al.
(2014a) as it was not a RCT. Concealment method in the study by Bustos et al. (2008)
was not mentioned in the text.
Studies conducted by Bustos et al. (2008), Cohen et al. (2015) and Taddio et al.
(2014c) were single-blinded while studies conducted by Taddio et al. (2014a) and
Taddio et al. (2015) were double-blinded.
Among five of the identified studies, the treatment and control groups of four of them
were similar at the beginning of the trial (Cohen et al., 2015; Taddio et al.,2014a;
Taddio et al., 2014c; Taddio et al.,2015) expect the one done by Bustos et al. (2008) in
which the characteristic of participating parents were not adequately described. The
only difference between the intervention and control groups of all studies were the
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parent-directed educational intervention in the intervention group. Outcome of all the
identified studies were measured in standard, valid and reliable instruments.
Except the study conducted by Cohen et al. (2015), all the identified studies stated
their drop-out rate clearly. Study performed by Bustos et al. (2008) had zero attrition
rate so there was no need to apply intention-to-treat (ITT). The overall drop-out rate
of the remaining three studies ranged from 19.5% to 31.7% (Taddio et al.,2014a;
Taddio et al., 2014c; Taddio et al.,2015). Only the one conducted by Taddio (2014b)
used ITT. Through modified ITT was used in the study by Taddio (2015), there was
no clear explanation for the reason. Studies conducted by Cohen et al. (2015) and
Taddio et al. (2014a) did not use ITT.
The results found by Taddio et al. (2014a) and Taddio et al. (2015) were comparable
for all sites whereas the remaining studies were single site.
Based on the above assessment, three studies were done well to minimise the risk of
bias in high quality (Cohen et al., 2015; Taddio et al., 2014c; Taddio et al., 2015). Two
kept the risk of bias to an acceptable level (Bustos et al., 2008; Taddio et al., 2014a).
All the studies calculated sample size carefully to meet the statistical powers. As a
result, level of evidence of the studies conducted by Bustos et al. (2008) was rated as
1+ while studies conducted by Cohen et al. (2015), Taddio et al. (2014c) and Taddio et
al. (2015) were rated as 1++. As the study carried out by Taddio et al. (2014a) was not
a RCT, it was rated as 1-.
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2.3 Summary and Synthesis
All studies evaluated the effectiveness of parent-directed educational materials by
either statistically significant increase in knowledge or use of well researched pain
management in the intervention groups when compared with the control groups.
Summarising the conclusions of the included studies, it was found that simple and low
cost intervention can increase knowledge and change the behaviour of parents during
childhood immunization. Through the interventions were effective, there was degree
of diversity among the studies.
2.3.1 Summary of data
The identified studies mainly used two types of educational intervention, printed
material and video-audio media, in directing the pain management to the subjects. The
printed materials used by Bustos et al. (2008), Taddio et al. (2014a), Taddio et al.
(2014c) and Taddio et al. (2015) were in one page. The information sheet used by
Bustos et al. (2008) were words describing the coping-promoting behaviour. In the
studies conducted by Taddio et al. (2014a), Taddio et al. (2014c) and Taddio et al.
(2015), they used the same pamphlet on pain management. Other than words
description, there were pictures illustrating the use of pain management which
visualized the strategies towards the participants. Taddio et al. (2015) even used poster
size pamphlet to magnify the effect of the pamphlet.
The video-audio material shown by Cohen et al. (2015) was in the form of animation
while the one by Taddio et al. (2015) was filmed on real situation. The mode of
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delivering was also different. Cohen et al. (2015) showed the animation by computer
with preventing the participants from skipping the important massage by pressing the
“Next” button of each session of the program while Taddio et al. (2015) showed the
video continuously in the waiting area.
The time of administering the educational intervention was different among the
studies. Bustos et al. (2008) and Taddio et al. (2014a) offered the information
materials to the participants before the day of immunization while Cohen et al. (2015)
Taddio et al. (2014c) and Taddio et al. (2015) offered the educational material on the
same day of immunization or outcome measure.
Taddio et al. (2014a) and Taddio et al. (2015) did not give special attention to their
subjects in reading the material while Bustos et al. (2008), Cohen et al. (2015) and
Taddio et al. (2014c) directed their subjects in reading it. Three of the studies do not
limit time for reading the materials (Bustos et al., 2008; Taddio et al., 2014a; Taddio et
al., 2015). Two studies limited the subject to read the materials in ten minutes (Cohen
et al., 2015; Taddio et al., 2014c)
The outcome measures for increase in knowledge level and use of scientifically
proven pain management of subjects were different among studies. For increase in
knowledge, Cohen et al. (2015) used Parent Procedural Behavior Knowledge Test
supplemented with visual analog scale to gather parent behavioural knowledge while
Taddio et al. (2014a) and Taddio et al. (2014c) used knowledge test based on the Help
Eliminate Pain in Kids clinical guideline to assess parents’ knowledge.
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All identified studies measured the use of pain management as outcome. Bustos et al.
(2008) observed the verbatim used by parents and coded by Child-Adult Medical
Procedure Interaction Scale-Revised. Cohen et al. (2015) observed parents’ behaviour
3 minutes before cleaning the skin till 3 minutes following the removal of needle or
parents left treatment room and coded by the behavioural coding scales. Research
assistants of the study conducted by Taddio et al. (2015) observed the use of pain
management strategies at the right time of each strategy without any coding scale.
Taddio et al. (2014a) and Taddio eat al. (2014c) relied on self-report of the pain
management used.
2.3.2 Synthesis of data
Parent-directed educational program could significantly increase the knowledge and
utilization of scientifically proven pain management of parents in MCHCs. The use of
pamphlet showed significant improvement in knowledge gain compared to no
intervention (Tuong, Larsen & Armstong, 2014). Showing video in general practice
waiting area was practical, acceptable and useful to a wide range of patients
(Koperski, 1989; Tuong et al., 2014). Combination of both printed and video-audio
materials was useful in magnifying the effect of the educational intervention. Among
all the identified studies, the effect size of utilization of pain management in the study
by Taddio et al. (2015) was the highest immediately after the implementation of the
educational intervention and showed significantly differently compared with standard
care. The effect persisted even after next vaccination. People with different
educational background benefited from combining video and written material (Stalker
& Elander, 2015). Less educated population benefited from video components which
17
were constructed carefully while highly educated population benefited from written
materials. Parents should be given written information as well as visualization for
ways to reduce pain in their children (Taddio et al., 2009; Taddio et al., 2013). Thus,
combining written material and video improve knowledge of health across people
with different education level, reaching health equality.
Education materials should be directed or reminded parents to read by health care
providers in order to enhance the knowledge and use of the strategies. Directing
participants reading and watching the educational materials showed significant
difference with the knowledge and use of pain management. Taddio et al. (2014a) did
not give special attention to their subjects in reading the material while Bustos et al.
(2008), Cohen et al. (2015) and Taddio et al. (2014c) directed their subjects in reading
or watching the educational materials. The immediate increase in knowledge and use
of pain management were significant with effect size ranged from 5.9 to 31.36 (Cohen
et al., 2015; Taddio et al., 2014c) and -0.07 to 2.32 (Bustos et al., 2008; Cohen et al.,
2015) respectively. Although studies conducted by Taddio et al. (2014c) reported an
increase in knowledge the next vaccination after the implementation of intervention,
the effect size was not as significant as those by Cohen et al. (2015). This might due
to subjects forgot the intervention after a long period of time.
Study by Taddio et al. (2014a) alone also concluded that participants who read the
information sheet, with effect size 1.0, significantly improved their knowledge
compare with the participants who did not read the pamphlet, with effect size 0.4,
even given to them.
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Education intervention should be provided immediately or on the same day of
immunization to achieve the most significant outcome. For the outcome of
knowledge, the effect size of studies which provided information on the same day of
immunization or outcome measure was much higher than that after a long period of
time before the outcome measure. The effect size ranged from 5.9 (Taddio et al.,
2014c) to 31.36 (Cohen et al., 2015) with p value less than 0.05 compared with 1.0
with p value equal to 0.023 (Taddio et al., 2014a). The same phenomenon was also
observed in the outcome of utilization of pain management with effect size ranged
from -0.07 (Cohen et al., 2015) to 43 (Taddio et al., 2015) compared with 2.31
(Bustos, et al., 2008). It was concluded that intervention should be delivered on the
day of the outcome measure.
2.3.3 Implication for practice
Parent-directed educational materials provided on the day of the vaccination can
increase the knowledge and utilization of pain management of parents during
immunization of children under six years old. It is recommended that the use of
printed and video-audio materials could be incorporated into the setting of MCHC
with the development of an evidence-based practice guideline in order to alleviate the
distress towards children, parents and health care providers as well as elevate the
adherence to the immunization schedule. Thus, the health of the whole community
can be safeguarded.
19
Chapter 3: Implementation Potential and Clinical Guideline
Before setting up a clinical guideline for the proposed innovation, the implementation
potential of the innovation should be considered, particularly the transferability,
whether the implementation of the innovation is suitable for a particular setting;
feasibility, whether any resources and support are available for the implementation of
the innovation; and cost-benefit ratio, whether it is worthwhile to implement the
innovation by considering the strengths and weaknesses of implementing and not
implementing the innovation (Polit & Beck, 2012).
3.1 Transferability
3.1.1 Target setting
There are thirty one MCHCs in Hong Kong implementing an integrated child health
and development program to promote health and wellbeing of children, in which
immunization is one of the core components of the program (FHS, 2014). Children at
or below 18-month-old are advised to have immunization as scheduled in MCHCs
while children 6 years old or below with incomplete immunization schedule can also
return to MCHCs for catching up the schedule. Around 84% of local born children
receive vaccines at MCHC (FHS, 2013).
The chosen MCHC is the busiest centre in New Territories West Cluster 2. Children
receive immunization during the child health service session of the target centre. It is
20
observed that around 85% of attendance received immunization at the target MCHC
in 2015.
3.1.2 Target audience
Parents usually accompany their child for immunization. After registering the service
of that day, nurses will interview parents whether the child is suitable for
immunization or not. The child will be proceed for vaccination if he or she is fit for
immunization. The target population of the proposed innovation is parents of child
receiving immunization in MCHC.
Considering the similarity of characteristics and philosophy of care between the
identified studies and the target setting as well as the target population, it helps in
determining whether the findings of the selected studies are transferable or not. The
number of clients who will be benefited from the innovation should be sufficiently
large. The time for implementation and evaluation should not be too long so it is
worth to carry out.
3.1.3 Similarity of the setting between the identified studies and the target setting
All the identified studies were carried out in developed countries, including Australia
(Bustos et al., 2008), USA (Cohen et al., 2015) and Canada (Taddio et al., 2014a;
Taddio et al, 2014c; Taddio et al., 2015). All these countries have well designed
immunization program to protect infants and children from infectious disease. The
21
Hong Kong Childhood Immunization Programme aims at protecting children staying
in Hong Kong away from VPDs.
Three of the reviewed studies recruited subjects and were took place in outpatient
immunization clinic (Bustos et al. 2008; Cohen et al., 2015; Taddio et al., 2015).
Through the studies done by Taddio et al. (2014a) and Taddio et al. (2014c) recruited
their subjects in the hospital setting, they evaluated the effectiveness of the
intervention after the subjects experienced childhood immunization. According to the
Government of Canada (2015), children in Canada receive free routine immunization
in outpatient clinic. Since the children of the identified studies were vaccinated in
outpatient clinic where shared the same characteristic as the MCHCs in the
community, the proposed innovation fits in the target setting.
3.1.4 Philosophy of care
The MCHC is a branch under FHS of DH. The vision of FHS is using strategies and
programs which are evidence-based to empower individuals, families and the
communities to promote the well-being and health of children and their families in
Hong Kong (FHS, 2014). The Human Care Science theory proposed by Waston
(1985) pointed out nursing should integrate science with the respect to the values of
human. The principle of the proposed innovation is in line with the vision of FHS and
the Human Care Science theory which aims to educate parents and empower them
with the skills regarding scientifically proven pain management to reduce painful
sensation of children during immunization, offering holistic care to both children and
their family by scientific strategies.
22
3.1.5 Similarity of characteristic of population between the identified studies and
the target setting
The subjects of the identified studies were parents who experienced the process of
immunization with their children ranged from infants (Bustos et al., 2008; Taddio et
al., 2014a; Taddio et al., 2014c; Taddio et al., 2015) to age between four and six years
(Cohen et al., 2015). The age range of children of the research audience fully covers
the service population of the target MCHC which offers service to children aged
below six years old.
3.1.6 Number of clients benefited from the innovation
Based on clinical observation, around 21316 children attending the child health
service session received immunization in the target MCHC in 2015. It is estimated
that parents of 1776 children per month, a sufficiently large number of clients, will be
benefited from the innovation.
3.1.7 Length of time for implementation and evaluation
It is expected that from preparation, implementation to evaluation, the innovation will
take approximately twelve months to be completed (Appendix F). The proposed
innovation will take two months for setting up working group to prepare proposal and
guideline of the education program, two months for seeking approval by the
administrative level of the department, another two months for preparation of
education pamphlet and video, one month for training the staff regarding the
23
scientifically proven pain management and the flow of the program, two months for
implementation and evaluation of the pilot testing and refining the guideline, one
month for formal implementation with three months of data analysis and evaluation of
the program.
Since the proposed education program shares similar characteristics in target setting,
audience and philosophy of care with a sufficiently large number of target population
being benefited in a reasonable length of time, the proposed innovation is transferable
in the target MCHC.
3.2 Feasibility
Support from the organization, the administrative level as well as frontline nurses
makes the implementation of an innovation easier. The availability of essential
resources and equipment helps smooth the process of implementation.
3.2.1 Organizational climate and administrative support
As stated in the mission statement of FHS, the organization supports the use of
evidence-based practice to improve the quality of care. Eliminating aspiration during
intramuscular vaccination, introduction of Pneumococcal Conjugate Vaccine and
Varicella Vaccine in 2009 and 2015 respectively and updating Childhood
Immunization Guideline periodically demonstrate the determination of FHS in
utilizing evidence-based result.
24
The administrators also support innovations and suggestions. “Sharing of Good
Practice Scheme” encourages exchange of new ideas to improve the delivery of
service. The Nursing Officer In-charge (NOIC) of the target MCHC welcomes
suggestions from frontline nurses to facilitate the process of service delivery
especially in the area of immunization. It is believed that the innovation can smooth
the process of immunization and is worth to be tested.
3.2.2 Consensus and friction among nurses
Half of the nurses in the target MCHC are university graduates. It is expected that
they are willing to accept the innovation as evidence-based practice is strongly
emphasised in their training. The major pocket of resistance which undermines the
efforts to implement and evaluate the innovation comes from the senior staff. Since
the senior staff have been working in the clinical setting for years, they usually make
clinical decision based on their own clinical experience without being proven
scientifically or on outdated belief. For example, nurses in the target MCHC prohibit
infant to be breastfed during vaccination, which is one of the well proven effective
strategies in relieving pain during immunization, as they believe drinking during
vaccination may led to choking.
3.2.3 Interference to current practice
The usual workflow for a child having immunization is registration first, measuring
growth parameter by nurse next, parents are then interviewed by nurse for dietary
habit of the child, developmental surveillance and suitability for immunization on that
25
day. The interview usually takes approximately 20 minutes to be completed. If the
children is suitable for immunization, the nurse will introduce the vaccine(s) and side
effects that the child will have after vaccination. Parents and child will then wait in
the waiting area for immunization. The whole process takes around one and a half
hours to be completed.
The innovation may interfere the current practice as it requires the interview nurses to
introduce a pamphlet of scientifically proven pain management briefly at the end of
the interview and the parents need to watch the pain management video which lasts
for around 10 minutes before vaccination. The implementation may slightly increase
the time of the workflow.
Through the implementation may affect the efficiency of service delivery, nurses have
the freedom to control and terminate the innovation if it is considered to be
undesirable as it is sorely a nursing intervention. There is no special skill needed to
carry out the innovation. However, educating nurses regarding the scientifically
proven pain management described in the pamphlet and video is essential. The
education session can be held during the weekly clinical meeting so that nursing staff
need not to be released from duty, keeping the interference to current practice to be
minimal.
3.2.4 Availability of resources and equipment
The plan for implementation of the innovation is to briefly introduce the pain
management pamphlet to the eligible parents at the end of the interview and then
26
arrange them to watch the video in the function room at the target MCHC. Since there
is no pamphlet and video regarding the pain management strategies available in the
current practice, Health Information Section of FHS will be invited for the production
of the pamphlet and video. The content of both pamphlet and video will be based on
the pamphlet used in the reviewed studies by Taddio et al. (2014a), Taddio et al.
(2014c) and Taddio et al. (2015), except the part of applying topical anaesthetics as it
is out of the scope of the proposed innovation, in cooperation of the pain management
described by Bustos et al. (2008) and Cohen et al. (2015). Details of the content is
shown in Appendix G. The final version of the pamphlet will have picture to magnify
the effect of the pamphlet. The members of the workgroup will be filmed for the
production of the video, minimising the interference to the manpower of the target
setting during the phase of the preparation of equipment.
Other than the pamphlet and video, the target MCHC already has a video player and a
function room for implementing the innovation.
3.2.5 Evaluation tool
To evaluate the increase in knowledge level and utilization of scientifically proven
pain management of the parents, the knowledge test used by the studies of Taddio et
al. (2014a) and Taddio et al. (2014c) and observation of the use of the scientifically
proven pain management are used. The chosen knowledge test is demonstrated to be
feasible in determining knowledge of parents regarding pain management in multiple
studies in the relevant topic. It is a valid measuring tool in this area. The knowledge
test composed of 9 true/ false question after modification with the elimination of
27
question regarding the use of topical analgesia which is out of scope of current
innovation. Observation is used as the outcome measure of the utilization of pain
management as most of the identified studies apply observation as the outcome
measure (Bustos et al., 2008; Cohen et al. 2015; Taddio et al., 2015) and it is much
more objective than self-report by parents. Details of the evaluation plan will be
discussed in the next chapter.
The proposed innovation is highly feasible in the target setting with supportive
organizational climate and frontline staff with minimum interference to current
practice.
3.3 Cost-Benefit Ratio
Balancing the cost of implementing and not implementing the innovation can
visualize the benefits of the innovation.
3.3.1 Potential risk of the innovation
The innovation is solely an education intervention. Thus, the risk of adverse exposure
is rare.
3.3.2 Potential benefits resulted from the innovation
Increasing parents’ knowledge regarding scientifically proven pain management
during childhood immunization helps alleviate stress and anxiety of parents as well as
28
reduces anxiety and irritability of children. On one hand, the level of cooperation of
both parents and children will increase during the procedure, minimising the chance
of injection incident. Thus, it reduces the stress of nurses during injection. On the
other hand, the chance of potential conflict between parents and nurses will reduce,
saving time for managing conflicts and increasing rapport between parents and nurses.
The sense of job satisfaction of nurses will increases.
The innovation also enhances the organization’s image as it offers holistic care to both
the children who receive direct service and their families. Alleviating distress of
parents regarding immunization also increases compliance of parents to adhere to
immunization schedule and willingness of parents to let their children receive multiple
vaccination in a single visit. On one hand, it safeguards the health of the public. On
the other hand, it reduces work stress of nurses as it helps reduce caseload of the
target setting as well as reduces resource for tracing defaulter of immunization. Thus,
staff morale and staff retention will be enhanced.
3.3.3 Risk and cost of maintaining current practice
Maintaining current practice without scientifically proven pain management advice
keeps children and parents uncooperative during vaccination. Children may develop
needle phobia in the future, parents will not adhere to the immunization schedule and
separate visit will be needed for catching up the immunization schedule of the same
children. Workload of nurses may thus increase.
29
3.3.4 Cost of the innovation
The material cost of the innovation is the production of evidence-based practice
guideline, pamphlet, video and evaluation form. The non-material cost comes from
time educating parents regarding the scientifically proven pain management described
in the pamphlet and video. Based on the information given by Civil Service Bureau
(2015), the mean monthly salary of a registered nurse in DH at Master Pay Scale point
19 is $32560 per month. It is estimated that the total material and non-material cost of
the innovation is $19707 per 1000 subjects per month (Appendix H). Financial
support will be granted from DH.
3.3.5 Cost of not implementing the innovation
Through it is observed that only 2% of parents prefer to spread immunization of their
children in a separate visit, additional visit of the same children puts a great burden to
the target MCHC. Extra 20 minutes and 5 minutes are needed for interviewing parents
and vaccinating children respectively for a repeated visit. Although the estimated cost
of repeated visit is far less than the implementation of the innovation (Appendix F),
the repeated visit will occupy the vacancy of booking, delaying the immunization
schedule of another child as there is quota system to control the clients being served
in the target setting. To minimise the risk of delaying immunization, additional quotas
are added for those who are on time for immunization, increasing workload as well as
reducing morale of nurses.
Since the benefits of the innovation outweigh its cost, it is valuable to implement the
30
innovation.
3.4 Evidence-Based Practice Guideline
Since the proposed innovation is transferable, feasible and cost effective, an evidence-
based practice guideline should be set up to facilitate implementation and
communication.
The recommendations of the guideline are based on the five reviewed research. A
grade is given to each recommendation so to determine the strength of evidence. The
grade is based on the Grades of Recommendation suggested by SIGN (2014)
(Appendix J).
The guideline with title “An evidence-based parent-directed education program in
increasing knowledge and utilization of pain management during childhood
immunization” is set up. It is targeted to be used by all nurses responsible for
interviewing parents before childhood immunization. The target group is the parents
of children below six years of age receiving immunization in the target setting. The
ultimate goal of the guideline is to increase parents’ knowledge and utilization of
scientifically proven pain management during childhood immunization. The full
version of the guideline is shown in Appendix K.
31
Chapter 4: Implementation Plan
Though the implementation potential of the proposed parent-directed education
program is affirmed with the evidence-based practice guideline being developed, a
detailed implementation plan, including communication plan for convincing the
stakeholders, pilot study for testing the feasibility of the innovation and plan for
evaluating the success of the innovation, is needed for action.
4.1 Communication Plan
4.1.1 The stakeholders
Stakeholders are those people or organization who have vested interests in the process
and outcome of the proposed innovation (Centers for Disease Control and Prevention,
2012; Schmeer, 1999). Identifying stakeholders is the fundamental step of proposing
any innovation as knowing the interests and concerns of each party helps developing
communication plan in promoting support and minimising opposition from them.
Three levels of stakeholders are identified in the proposed innovation. Approval
should be granted from the higher level of an organization before the implementation
of any new ideas. Gaining support from the administrative level of FHS, including the
Senior Nursing Officer (SNO) of New Territories West Cluster II, Chief Nursing
Officer (CNO) and Principle Nursing Officer (PNO), helps getting both material and
non-material support which facilitate the implementation of the innovation.
The innovation is carried out by frontline staff. Therefore, motivating the people at
clinical level to participate actively is essential. The first step is proposing the idea to
32
the NOIC of the target MCHC as she is the leader of the clinic. She helps conveying
the message to the administrative level for approval. She also supervises the overall
operation of the innovation and makes appropriate adjustment between the innovation
and routine functioning of the clinic. Frontline nurses are the actual users of the
guideline. Getting their support and cooperation makes the implementation of the
innovation much easier.
Parents of the children who receive immunization in the designated clinic are the
actual recipients of the innovation. Communicating with them helps understanding the
effectiveness of the innovation.
4.1.2 The process of communication
The communication process should be started by approaching the NOIC. Discussing
the observed problem and the need for change of current practice arouse her interest
of the innovation. Informing the benefits and evidence behind the innovation
increases her understanding. Indicating the aim of the innovation makes her with a
clearer idea on how to accomplish the goal.
When NOIC agrees for the innovation, a working group will be set up to prepare
proposal for approval from administrative level, develop the guideline, prepare
necessary equipment for the innovation and design timeline to guide the change. The
working group will consist of one Nursing Officer (NO) and two Registered Nurses
including the subject nurse of immunization in the target clinic. These three members
will share the responsibility and reach consensus regarding the details of the education
33
program. Bi-weekly meetings in two-month time in the preparatory phase will be
necessary to come to a unanimous decision of the innovation.
The proposal will be presented to the SNO to gain her approval and support next.
With the help of NOIC and NO in the working group, SNO will be invited to attend a
one-hour meeting regarding the innovation in the clinic. Other than the proposal, the
cost and benefit of the innovation will be emphasised so that she will have a clearer
picture of the benefit of the innovation as it will be launched in the other MCHCs if
the innovation is successful in the target clinic. Higher level of approval from CNO
and PNO should be gained through SNO. It is estimated the process will take three
months to be completed.
After gaining approval from the administrative level, launching of the education
program should be disseminated to frontline staff during clinic meeting. Informing the
staff the reason behind the innovation increases their awareness and acceptance of
teaching parents pain management during immunization. Persuading them with the
benefits from implementing the new idea reduces their resistance. Introducing the
guideline, education materials and logistic of the innovation smoothens the process of
the implementation. Encouraging staff to express their concerns, questions and
opinion helps revise the guidelines before implementation. Two clinic meetings will
be held for this purpose with each meeting last for one hour.
The ultimate goal is to introduce scientifically proven pain management to the parents
through the parent-directed education program. The education pamphlet will be
briefly introduced to parents by nurses while the education video will be broadcasted
34
to parents in the function room before the children receive immunization. Evaluating
outcomes in different perspective helps sustaining the change. The evaluation plan
will be discussed later in this chapter.
4.2 Pilot Study Plan
A pilot test with a small number of clients representing the target group of the
innovation should be conducted to identify possible problems and make appropriate
correction before the actual implementation (Hodges & Videto, 2011). Participants
with the same inclusion and exclusion criteria of the innovation will be recruited in
the pilot study. 17 clients will be invited to participate in the pilot study. It is expected
that the study will take one service session to be completed.
Before the pilot study, briefing session regarding the parent-directed education
program will be given to the nurses in the target MCHC. The background, evidence,
content of the education pamphlet and video, the logistic of the education program
and data collection method will be introduced. The materials, including the education
pamphlet, video, video player and all the forms for evaluation will be prepared by the
working group prior to the beginning of the pilot study.
The clients will be recruited when they approach the registration counter for
immunization service for their children. The clerk in the registration counter will ask
for verbal consent from the parents for the pilot study. If the parents agree to join the
study, explanatory notes on the purpose of the innovation, consent form and the
knowledge test (Appendix L) will be given to clients as pre-test and clients will be
35
asked to fill in the knowledge test while they are waiting for a routine nurse interview.
The interviewing nurse will collect the consent form and pre-test before the routine
interview. At the end of the interview, the interviewing nurse will distribute the
education pamphlet with brief introduction of the pamphlet to the clients. The clients
will then be arranged to watch the video in the function room of the clinic. Each video
broadcasting session will accommodate 5 to 7 clients and will take around 10 minutes
to complete. The same knowledge test will be distributed to clients as post-test after
watching the video by one of the member of the working group and will be collected
before the children proceed to treatment room for immunization. A self-developed
satisfactory questionnaire will be distributed to clients before they leave the function
room and they will be reminded to fill in the questionnaire after immunization.
Another member of the working group will observe the behaviour of the parents
during childhood immunization in the treatment room using a standardised
observation form (Appendix M). The observation will start when the injection nurse
askes the client to prepare a child for immunization and will end when the client
leaves the room. The clients need to hand in the self-developed satisfactory
questionnaire (Appendix N) to the booking counter when they book the next
appointment before leaving the clinic.
The recruitment of clients will start at the second time slot of the service so the
routine service will not be interrupted. The three members of the working group will
take turns in the position of video broadcasting, observation of parents’ behaviour in
the treatment room and supporting the other staff so they can discuss the obstacles
each of the members have in different positions for refining the logistic. Feedback
36
from the staff involved in the pilot study, including the clerk, interviewing nurse and
injection nurse, will be collected in the clinic meeting after the pilot study.
Modification of the process of the innovation will be made accordingly before the full
implementation.
4.3 Evaluation Plan
Evaluation should be done to determine the success of the innovation and make
appropriate modifications for sustaining the change (Centres for Disease Control and
Prevention, 2012). Identifying the outcomes to be achieved, estimating sufficient
sample size to achieve statistical power, collecting data at an appropriate time and
analysing the data with correct method ensure the reliability of the results.
4.3.1 Outcomes to be achieved
Outcomes can be classified as three aspect, client outcome, staff outcome and system
outcome.
The primary outcome of client is to increase their level of knowledge of scientifically
proven pain management. The secondary outcome is to increase the use of
scientifically proven pain management during childhood immunization. The
knowledge test adopted by Taddio et al. (2014a) and Taddio et al. (2014c) is used to
assess the level of knowledge of clients. It is a valid tool as it is specifically designed
to assess the changes in knowledge uptake regarding the scientifically proven pain
relieving interventions based on the Help Eliminate Pain in KIDS clinical practice
37
guideline which summarises various scientifically proven pain relieving strategies
during childhood immunization (Taddio et al.,2014a; Taddio et al., 2014c). It consists
of 10 true or false question originally. Modification is made with the elimination of
the question regarding the use of topical analgesia which is not included in the
proposed innovation. Thus, the knowledge test composes of 9 questions to suit the
need of the innovation. It is expected that the level of knowledge related to
scientifically proven pain management will be increased by one level after receiving
the education program.
Observation of the use of scientifically proven pain management measure will be used
to assess the secondary outcome of client. Observation is chosen as the measuring tool
since three out of five of the selected articles observe the utilization of pain
management (Busto et al., 2008; Cohen et al., 2015; Taddio et al., 2015). It is much
more objective than self-report used by Taddio et al. (2014a) and Taddio et al. (2014c)
as parents may forget or not aware of the strategies that they have used. Clear
definition of use of each scientifically proven pain management is prepared before the
launching of the innovation. Thus, it will reduce the bias of inconsistency between
different observers. It is expected that the clients will use one or more scientifically
proven pain management, including sugar water, breastfeeding or bottle feeding and
holding child without instruction from the injection nurse, at the right time during
childhood immunization after the education program (Appendix M). These pain
management strategies are chosen since they are effective in relieving pain in infant
and children but uncommonly used (Taddio et al., 2015), which is the same
phenomenon observed in the target MCHC. They are also easily identified by the
observer of the working group during the vaccination.
38
For staff outcome, it is expected that frontline nurses will have positive attitude
towards the evidence-based parent-directed education program. A semi-structured
evaluation meeting with staff will be held to assess this outcome (Appendix O).
For the organization outcome, the reputation of the service will increase as the clients
will be more satisfied with the service. Self-developed satisfaction questionnaire
(Appendix N) is used to analysis the satisfactory level of client. It consists of 6 items
regarding the content of both pamphlet and video, whether the program increases
clients’ level of understanding and competence in managing childhood immunization
pain and the supportiveness of the staff. It is expected that the clients will have high
satisfactory level regarding the innovation.
4.3.2 Nature and number of clients involved
Since majority of the population in the target MCHC are Hong Kong Chinese, the
knowledge test and self-developed satisfactory questionnaire will be translated to
Chinese. Parents accompanying child for immunization in the target clinic who are
proficient in written Chinese and spoken Cantonese will be included. Parents of at risk
case, that is either parent with mental illness or substance abuser and teenage mother,
or parents of preterm baby are excluded.
Sample size calculation will be based on the primary outcome for estimation. Since
the standard deviation of change in knowledge is 3 in the selected studies, using one-
sample t-test with power of 0.8 and significance level of 0.05, 73 subjects will be
necessary for the evaluation of meaningful difference in knowledge level. Considering
39
an attribute rate of 10%, 82 subjects will be needed for the innovation. Convenient
sampling method will be used to recruit clients in 5 service sessions.
4.3.3 Time to take measurement
For both the primary, secondary and organization outcomes, the measurement will be
taken on the day when the clients agree for participating in the innovation. Knowledge
test will be given to clients prior to receiving any education materials regarding the
scientifically proven pain management as the pre-test on the day of receiving the
immunization service. After clients receives all the education material, the same
knowledge test will be given as post-test to determine the level of knowledge change.
A member of the working group will observe the use of scientifically proven pain
management during childhood immunization on the same day of receiving
intervention to determine the use of pain management. Clients need to fill in the
satisfactory questionnaire before leaving the clinic the same day for system outcome.
The semi-structured meeting for evaluating the staff outcome will be held in the
weekly clinic meeting one week after the implementation of the innovation to collect
feedback from nurses.
4.3.4 Data analysis
The data collected will be analysed by Statistical Package for Social Science (version
22) for Windows. For client outcome, one sample t-test will be used to analysis the
difference between the pre-test and post-test knowledge level. Logistic regression will
40
be used to analysis the use of scientifically proven pain management by clients as the
clients either use or no use of the pain management, a dichotomous variable. For staff
outcome, feedback in the semi-structured meeting will be summed up for evaluation.
Independent t-test will be used to analysis the satisfactory level of client for system
outcome. The demographic data of clients will be analysed by descriptive statistics.
It is estimated that the process of data analysis will take 4 weeks to be completed.
Evaluation of the whole implementation process will be finished within two weeks.
The whole process will take eight weeks to complete.
4.4 Basis for Implementation
For client outcome, based on the selected studies, it is found that the minimum
increase in knowledge is by mean of one after receiving the education program.
According to Taddio et al. (2014a), at least 10.5% of participants increase in level of
knowledge after the intervention. It is expected that 10.5% of parents with mean score
of the knowledge test increased by 1, the innovation is regarded as successful. The
innovation will be more persuasive if the secondary outcome is also achieved, that is
either 80% of parents use one or more pain management during immunization as the
result of Taddio et al. (2015).
The staff outcome is achieved if the nurses verbalise the innovation has positive
impact in their daily work, they have control over the innovation with the difficulties
can be overcome with minimal barriers during the semi-structured meeting. For the
41
system outcome, if more than 70% of parents report “strongly agree” or “agree” for
all items in the satisfactory questionnaire.
If the outcomes of the above three aspects are met, the implementation of innovation
in the target MCHC is regarded as successfully. The innovation will be fully
implemented in all the MCHCs in Hong Kong, providing benefits to more parents,
children, staff and the whole department.
42
Chapter 5: Conclusion
Immunization is a powerful strategy in reducing VPDs. The low level of notifications
of VPDs in infants and children is achieved by adherence to the Hong Kong
Childhood Immunisation Programme. Majority of infants and children are vaccinated
in MCHCs. To maintain the satisfactory level of protection, infants and children may
need to receive more than one injection in a single visit. The pain induced by
vaccination leads to distress in children, parents and health care providers. The
immunization-induced pain makes the children uncooperative during vaccination and
it may lead to needle phobia when they grow up. The unrelieved pain is a contributing
factor for nonadherence to immunization schedule as parents are stressful when they
witness their children suffer from immunization-induced pain. The uncooperative
behaviours of children or parents during vaccination increase the work stress of nurses
in MCHCs.
Although scientifically proven pain management are available, they are seldom used.
The reason behind is that there is no education intervention regarding pain
management during childhood immunization available in current practice of MCHCs.
Thus, parents do not know that an effective strategy can help their children to relieve
pain during vaccination. Through there are researches showing parent-directed
education program which can increase parents’ knowledge and utilization of pain
management during childhood immunization, there is no systematic review on this
area.
In this translational nursing research, five current literatures are reviewed
43
systematically. After determining the implementation potential of the innovation, an
evidence-based practice guideline is developed. It is target to be used by all nurses
interviewing parents of children receiving immunization in a target MCHC. The
printed and video-audio educational materials are offered to parents on the day of
childhood immunization to obtain the best result. A communication plan is contrived
to gain support from all the stakeholders. A pilot study and evaluation plan are
planned carefully before the actual implementation of the innovation. It is believed
that the guideline can increase parents’ knowledge and the use of scientifically proven
pain management during childhood immunization. Thus, the quality of life of both
parents and children as well as the quality of service of MCHCs will be improved.
Total Words: 9742
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Appendix A
Hong Kong Childhood Immunisation Programme
Age Immunisation RECOMMENDED for infants and children below six
Newborn B.C G. Vaccine
Hepatitis B Vaccine – First dose
1 month Hepatitis B Vaccine – Second dose
2 month DTaP-IPV Vaccine – First dose
PCV – First Dose
4 month DTaP-IPV Vaccine – Second dose
PCV – Second dose
6 month Hepatitis B Vaccine – Third dose
DTaP-IPV Vaccine – Third dose
PCV – Third Dose
12 month MMR Vaccine – First dose
PCV – Booster dose
Varicella Vaccine – First dose
18 month DTaP-IPV Vaccine – Booster dose
B. C. G. = Bacille Calmette-Guerin;
DTaP-IPV = Diphtheria, Tetanus, Acellular Pertussis and Inactivated Poliovirus;
PCV = Pneumococcal Vaccine;
MMR = Measles, Mumps & Rubella
(FHS, 2014)
45
Appendix B Levels of Evidence
Levels of Evidence Description
1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias
1+ Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias
1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias
2++ High quality systematic reviews of case control or cohort or studies High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal
2+ Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal
2- Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal
3 Non-analytic studies, e.g. case report, case series
4 Expert opinion
(SIGN, 2014)
46
Appendix C PRISMA 2009 Flow Diagram
Iden
tifi
cati
on
Record identified
through database
searching in PubMed
on 9/12/2015
(n=36)
Record identified
through database
searching in ISI Web of
Science on 9/12/2015
(n=18)
Record identified
through database
searching in British
Nursing Index on
21/11/2015
(n=1)
↓ ↓ ↓
Scr
eenin
g
Records after duplicates removed
(n= 44)
↓
Records screened
(n= 6)
→ Records excluded
(n=38)
↓
Eli
gib
ilit
y
Full-text articles assessed for
eligibility
(n=5)
→ Full-text articles
excluded
(n=1)
Evaluating the usability
of an educational
pamphlet and video
↓
Incl
uded
Studies included in
qualitative synthesis
(n=5)
(Mocher et al., 2009)
47
Appendix D Table of Evidence
Citation / Design
(Study quality)
Sample
Characteristics
Intervention
Group
Control
Group
Outcome measure
(Assessment time)
Effect Size
(Intervention –Control)
Bustos, Jaaniste,
Salmon &
Champion (2008)
RCT (1+)
Parents of 6-
month-old
children for
immunization at
clinic
1. 40 mothers
(80%)
Pamphlet on
coping-promoting
behavior
N=30
Standard Care
N=32
1. Utilization
- CAMPIS-Rª
- Immediate before
vaccination
Immediate before vaccination 1. Mean of coping-promoting statements
= 2.32 (p<0.01)
Cohen et al. (2015)
RCT (1++)
Parents of 4- to
6-year-old
children for
immunization at
clinic
1. Mean age: 38yrs
2. 78 mothers
(86.7%)
10-minute
animated
computer training
program
N=30
Standard Care
N=30
1. Knowledge
- Parent Procedural Behavior
Test
- VASs
- Immediate post-vaccination
- Three months later
2. Utilization
- Behavioral coding scales*
Immediate post-vaccination 1. Mean of Reassuring =31.36 (p<0.05)
Mean of Providing information = 18.93 (p<0.05) Mean of Apologizing = 15.09 (p<0.05)
2. Mean of Distracting = 0.1 (p<0.05) Mean of Deep breathing = 0.02(p<0.05) Mean of Reassuring = -0.07(p<0.05) Three months later
1. Mean of Providing information = 13.65 (p<0.05) Mean of Apologizing = 15.76 (p<0.05)
Taddio et al.
(2014a)
Controlled before-
and-after study (1-)
Mothers just
given birth to
infants in
postnatal ward
1. Mean age
(I) 30-32 years
(C) 33 years
Black and white
pain management
pamphlet without
special attention
drawn to mothers
N=220
Standard Care
N=220
1. Knowledge
- Knowledge test
- After next vaccination
2. Utilization
- Self report
- After next vaccination
After next vaccination
1. Mean = 0.4 (p=0.115)
2. Mean =0.2 (p=0.935)
For mothers who had read the pamphlet
in invention site
1. Mean = 1.0 (p=0.023)
2. Mean = 0.2 (p=0.294)
48
CAMPIS-R: Child-Adult Medical Procedure Interaction Scale-Revised; VASs: Visual analog scale; (I): Intervention group; (C): Control group;
ªThe use of statements were recorded for 30 seconds before the vaccination
*Observation by video recording for the parents’ behavior 3 minutes before cleaning the skin till 3 minutes following removal of needle/ parents left treatment room
** Observation by video recording. Use of one or more evidence-based pain management strategy at the right time for optimal analgesia was recorded
For study done by Cohen et al. (2015), the intervention group is compared to the control group which is related to the research topic, the distraction only group was ignored
For study done by Taddio et al. (2014c), the whole intervention group (the pamphlet only group and pamphlet with pretest group) is compared to the whole control group
(control group and control with pretest group)
Taddio et al.
(2014c)
Solomon 4-group
RCT (1++)
Mothers just
given birth to
infants in
postnatal ward
1. Mean age
(I) 32.2 years
(C) 33.9 years
Pain management
pamphlet and
pain management
pamphlet with
pretest
N=60
Factsheet on
normal growth
and factsheet on
normal growth
with pretest
N=60
1. Knowledge
- Knowledge test
- Immediate post
intervention
- After next vaccination
2. Utilization
- Self-report
- After next vaccination
Immediate post-intervention
1. Mean = 5.9 (p<0.05)
After next vaccination
1. Mean = 0.2 (p=0.27)
2. Mean = 0.1 (p=0.89)
Taddio et al. (2015)
Cluster RCT(1++)
Parents of 2- or
4-month-old
infants for
immunization at
clinic
1. Mean Age:
(I) 33.2 years
(C) 32.8
Pain management
pamphlet, video
and poster
N= 80
Standard Care
N=80
1. Utilization
- Observation**
- Immediate post-vaccination
Immediate post-vaccination
1. Mean = 43 (p<0.001)
49
Appendix E
Checklist of SIGN
Bustos, T., Jaaniste, T., Salmon, K., & Champion, G. D. (2008). Evaluation of a brief parent
intervention teaching coping-promoting behavior for the infant immunization context: A randomized
controlled trial. Behavior Modification, 31(4), 450-467.
Section 1: Internal Validity
In a well conducted RCT study …
1.1 The study addresses an appropriate and
clearly focused question Yes
PICO is clearly stated
1.2 The assignment of subjects to treatment
groups is randomised Yes By computer-generated random
numbers table
1.3 An adequate concealment method is used Can’t say Outcome assessor is not
aware of the condition which the parent-
infant pairs are assigned but method of
concealment is not mentioned
1.4 Subjects and investigators are kept ‘blind’
about treatment allocation Yes
Outcome assessor is kept blinded
1.5 The treatment and control groups are similar
at the start of the trial Can’t say Though there is no
significant different in terms of gender, age
and gestational age of the infants, the
characteristic of parents have not been
described adequately
1.6 The only difference between groups is the
treatment under investigation Yes The only difference between the
group is the recipient of information sheet
on coping-promoting behavior
1.7 All relevant outcomes are measured in a
standard, valid and reliable way Yes Parents’ behavior is coded by the
Child-Adult Medical Procedure Interaction
Scale-Revised.
1.8 What percentage of the individuals or
clusters recruited into each treatment arm of
the study dropped out before the study was
completed?
0%
1.9 All the subjects are analysed in the groups
to which they were randomly allocated
(often referred to as intention to treat
analysis)
No
No drop out
1.10 Where the study is carried out at more than
one site, results are comparable for all sites
Does not apply
Study is done in a clinic
Section 2: Overall Assessment of the Study
2.1 How well was the study done to minimise
bias?
Code as follows:
Acceptable (+)
2,2 Taking into account clinical considerations,
your evaluation of the methodology used,
and the statistical power of the study, are
you certain that the overall effect is due to
the study intervention?
Yes
The recruited sample is enough to detect a
significant effect
2.3 Are the results of this study directly
applicable to the patient group targeted by
this guideline?
Yes
50
Cohen, L. L., Rodrigues, N. P., Lim, C. S., Bearden, D. J., Welkom, J. S., Joffe, N. E., McGrath, P.
J., & Cousins, L. A. (2015). Automated parent-training for pre-schooler immunization pain relief: A
randomized controlled trial. Journal of Pediatric Psychology, 40(5), 526-534.
Section 1: Internal Validity
In a well conducted RCT study …
1.1 The study addresses an appropriate and
clearly focused question Yes
PICO is clearly stated
1.2 The assignment of subjects to treatment
groups is randomised Yes By computer-generated random
number table
1.3 An adequate concealment method is used Yes Concealed in a binder and is only
revealed when the participants agree to join
the study
1.4 Subjects and investigators are kept ‘blind’
about treatment allocation Yes Nurse who administers the
vaccine is blinded to the study
1.5 The treatment and control groups are similar
at the start of the trial Yes No significant difference in race,
gender, marital status, income, education
level and number of injections between the
groups
1.6 The only difference between groups is the
treatment under investigation Yes No other information regarding
pain relief measures is provided
1.7 All relevant outcomes are measured in a
standard, valid and reliable way Yes Visual analog scale, which is
commonly used in pediatric procedural
distress studies, is used for assessing
parental knowledge
Standardized behavioral coding scale is used
to code the parental and child behavior
during the procedure
1.8 What percentage of the individuals or
clusters recruited into each treatment arm of
the study dropped out before the study was
completed?
No No mention regarding the
participants drop out from the study at the
phase of follow up 90 days later after the
intervention
1.9 All the subjects are analysed in the groups
to which they were randomly allocated
(often referred to as intention to treat
analysis)
No
Follow up data are not included if the
participants cannot be reached at the 90 days
follow up
1.10 Where the study is carried out at more than
one site, results are comparable for all sites
Does not apply
In only one site
Section 2: Overall Assessment of the Study
2.1 How well was the study done to minimise
bias?
Code as follows:
High quality (++)
2,2 Taking into account clinical considerations,
your evaluation of the methodology used,
and the statistical power of the study, are
you certain that the overall effect is due to
the study intervention?
Yes. RCT is used to determine whether the
intervention is useful for parents in
engaging evidence-based pain relief
measure during preschoolers’ vaccination.
Sample size is carefully calculated based on
previous study. Enough participates are
recruited in each arm of the study. It is
certain that the overall effect is due to the
study intervention.
2.3 Are the results of this study directly
applicable to the patient group targeted by
this guideline?
Yes
51
Taddio, A., MacDonald, N. E., Smart, S., Parikh, C., Allen, V., Halperin, B., & Shah, V. (2014a).
Impact of a parent-directed pamphlet about pain management during infant vaccinations on maternal
knowledge and behaviour. Neonatal Network, 33(2), 74-82.
Section 1: Internal Validity
In a well conducted RCT study …
1.1 The study addresses an appropriate and
clearly focused question Yes
PICO is clearly stated
1.2 The assignment of subjects to treatment
groups is randomised No
It is not a RCT
1.3 An adequate concealment method is used No It is not a RCT
1.4 Subjects and investigators are kept ‘blind’
about treatment allocation. Yes Participants and outcome
assessors are blinded to the study.
1.5 The treatment and control groups are similar
at the start of the trial Yes No significant difference in the
marital status, education level and age of
mothers and the mode of delivery, maturity
and age of vaccination of infants between
control and intervention group
1.6 The only difference between groups is the
treatment under investigation Yes Various methods are used to
reduce the potential bias of the study. For
example, participants are not told the nature
of the research so to reduce the risk of
participants finding the information
regarding the research topic
1.7 All relevant outcomes are measured in a
standard, valid and reliable way. Yes Standardized survey and
knowledge test is used
1.8 What percentage of the individuals or
clusters recruited into each treatment arm of
the study dropped out before the study was
completed?
Overall = 19.5%
Intervention group = 18.2%
Control group = 20.9%
1.9 All the subjects are analysed in the groups
to which they were randomly allocated
(often referred to as intention to treat
analysis)
No
No ITT is mentioned
1.10 Where the study is carried out at more than
one site, results are comparable for all sites.
Yes No marked difference between
the intervention and external control sites in
terms of number of delivery per years, nurse
to mother-infant dyads ration, treatment
after delivery and knowledge and use of
pain management at the before
implementation phase
Section 2: Overall Assessment of the Study
2.1 How well was the study done to minimise
bias?
Code as follows:
Acceptable (+)
2,2 Taking into account clinical considerations,
your evaluation of the methodology used,
and the statistical power of the study, are
you certain that the overall effect is due to
the study intervention?
Yes. The authors minimize the bias of the
study by blinding the participants and
outcome assessors of the natural and using
valid standardized survey for assessing
participants’ knowledge. The rate of
response is also high.
2.3 Are the results of this study directly
applicable to the patient group targeted by
this guideline?
Yes
52
Taddio, A., Ipp, M., Vyas, C., Parikh, C., Smart, S., Thivakaran, S., … Shah, V. (2014c). Teaching
parents to manage pain during infant immunizations. Laying the foundation for better pain
management practices. Clin J Pain, 30(11), 987-994.
Section 1: Internal Validity
In a well conducted RCT study …
1.1 The study addresses an appropriate and
clearly focused question Yes
PICO is clearly addressed
1.2 The assignment of subjects to treatment
groups is randomised Yes By off-site computer random
numbers table.
1.3 An adequate concealment method is used Yes By sequentially numbered
opaque sealed envelopes
1.4 Subjects and investigators are kept ‘blind’
about treatment allocation. Yes Outcome assessor who
conducted the interview is kept blinded
1.5 The treatment and control groups are similar
at the start of the trial Yes No significant difference in the
maternal age, parity, marital status and
maternal feeling towards immunization,
gestational age, mode of delivery and birth
weight of infants between the four groups.
1.6 The only difference between groups is the
treatment under investigation Yes No important differences
between the control and intervention groups.
1.7 All relevant outcomes are measured in a
standard, valid and reliable way Yes Outcome measures are clearly
stated as knowledge test with 5-point Likert
scale. The knowledge test has been used to
assess knowledge of mothers in previous
study. For answer in the knowledge to be
scored, participants need to answer the
question correctly with indication of “very
sure” to that answer.
1.8 What percentage of the individuals or
clusters recruited into each treatment arm of
the study dropped out before the study was
completed?
Overall = 31.7%
Intervention group = 26.7%
Control group = 35%
1.9 All the subjects are analysed in the groups
to which they were randomly allocated
(often referred to as intention to treat
analysis)
Yes
ITT is used
1.10 Where the study is carried out at more than
one site, results are comparable for all sites.
Does not apply
The study is taken place at a perinatal
hospital in Canada
Section 2: Overall Assessment of the Study
2.1 How well was the study done to minimise
bias?
Code as follows:
High quality (++)
2,2 Taking into account clinical considerations,
your evaluation of the methodology used,
and the statistical power of the study, are
you certain that the overall effect is due to
the study intervention?
Yes. Rigorous randomised controlled trial
and validated outcome measurements are
used. Through 31.7% of participants drop
out from the study, there is no significantly
difference in the characteristics between
those who can be contacted and those who
cannot. Nonresponse bias dose not affect the
observed results on follow up.
2.3 Are the results of this study directly
applicable to the patient group targeted by
this guideline?
Yes
53
Taddio, A., Parikh, C., Yoon, E. W., Sgro, M., Singh, H., Habtom, E., Ilersich, A. F., Riddell, R. P., &
Shah, V. (2015). Impact of parent-directed education on parental use of pain treatments during
routine infant vaccinations: a cluster randomized trial. Pain, 156(1), 185-191.
Section 1: Internal Validity
In a well conducted RCT study …
1.1 The study addresses an appropriate and
clearly focused question Yes
PICO is clearly addressed
1.2 The assignment of subjects to treatment
groups is randomised Yes By off-site computer random
number generator
1.3 An adequate concealment method is used Yes It is a cluster RCT
1.4 Subjects and investigators are kept ‘blind’
about treatment allocation Yes Participants and outcome
assessors are kept blinded
1.5 The treatment and control groups are similar
at the start of the trial Yes No statistically significant
differences between the intervention and
control groups in terms of maternal
characteristics, ethnicity, parity and number
of children of participants and infant
characteristics
1.6 The only difference between groups is the
treatment under investigation Yes Standardized study procedures
are used to minimize bias as nurses who
administering vaccine work in multiple
clinics
1.7 All relevant outcomes are measured in a
standard, valid and reliable way Yes Numerical rating scale, Modified
Behavioral Pain Scale and crying duration
are used as outcomes measures
1.8 What percentage of the individuals or
clusters recruited into each treatment arm of
the study dropped out before the study was
completed?
Overall = 21.3%
Intervention group = 25%
Control group = 14%
1.9 All the subjects are analysed in the groups
to which they were randomly allocated
(often referred to as intention to treat
analysis)
Can’t say
Modified intention-to-treat is used without
explanation
1.10 Where the study is carried out at more than
one site, results are comparable for all sites.
Yes No difference between the sites in
terms of usual practice of vaccination
Section 2: Overall Assessment of the Study
2.1 How well was the study done to minimise
bias?
Code as follows:
High quality (++)
2.2 Taking into account clinical considerations,
your evaluation of the methodology used,
and the statistical power of the study, are
you certain that the overall effect is due to
the study intervention?
Yes. Cluster randomization design is used to
minimize bias. Standardized study
procedures and data collection method are
used to minimize contamination between the
intervention and control groups. Though
21.3% of drop-out rate is observed, it is
typical in the study setting as the study
setting is a temporary measure after infant
birth. It is also common a high drop out rate
observed in studies conducted over a long
period of time. So the authors account for
10% loss during calculating the sample size
to increase the number of participants in
order to reduce the bias of the study.
2.3 Are the results of this study directly
applicable to the patient group targeted by
this guideline?
Yes
54
Appendix F
Time Schedule for Implementation Process of the Innovation
Task Month 1 2 3 4 5 6 7 8 9 10 11 12
Preparation of proposal & guideline by working group
Approval of proposal by the administrative level of DH
Preparation of equipment
Staff training
Pilot testing, evaluation of pilot test and refining guideline
Formal implementation of innovation
Data analysis and evaluation
55
Appendix G
Content of the Pamphlet and Video
A) Pharmacological Strategies
i) Sugar Water
Give baby sugar water to drink right before the injection
Prepare sugar water by mixing 1 teaspoon of sugar with 2 teaspoons of water
B) Physical Strategies
i) Hold Upright
Hold baby close during injection, in a hug or on your lap.
ii) Breastfeeding
Breastfeed baby before, during and after injection
If baby cannot be breastfeed, offer a bottle or pacifier instead
C) Psychological Strategies
i) Deep Breathing
Breath so the stomach expands, not the chest
For parents
Stay calm and deep breath. This helps your child stay calm as he/ she looks to parents
for how to act and feel
If parents are nervous, take a few slow deep breaths to calm yourself down before and
during the injection
For child 3 years old or above
Teach child how to breath slow and deep
ii) Distraction
Methods which keep baby’s attention away from the injection:
Rocking, cuddling, singing, sucking (breastfeeding or pacifier), toys
Coping-promoting talk
a) Humor or Praise
“This is a Super Baby’s job”
b) Non-procedural Talk
“We’re going to watch movie later on”
c) Prompt to use a coping strategy
“Look at Mami/ Daddy”
(Bustos et al.,2008; Cohen et al. (2015); Taddio et al., 2014a;
Taddio et al., 2014c; Taddio et al. ,2015)
56
Appendix H
Costs of the Innovation
Material Cost per 1000 subjects
Item Budget Estimation
(HKD)
Cost
(HKD)
Guideline for Nurses ( 3 pages) $0.5/page x 3 x 1000 $1500
Education pamphlet(1 page) $0.5/page x 1 x 1000 $500
Evaluation form (1 page) $0.5/page x1 x 1000 $500
Video production $11000 $11000
DVD production (2 copies) $20/copy x 2 $40
Subtotal $13540
Non material cost per 1000 subjects
Additional time for brief introduction of
pamphlet (2 minute)
$185 x 2 /60 x 1000 $6167
Subtotal $6167
Grand total $19707
The mean monthly salary of registered nurse in DH at Master Pay Scale point 19 is
$32560 per month. Having to work 44 hours per week and 4 weeks per month, the
hourly salary for registered nurse in MCHC is $32560/44/4 = $185 per hour (Civil
Service Bureau, 2015)
57
Appendix I
Cost of Not Implementing the Innovation
Non material cost per 20 repeated visit
Item Budget Estimation (HKD) Cost (HKD)
Nurse interview (20 minutes) $185 x 25/60 x20 $1542
Vaccination (5 minutes)
Grand Total $1542
2% of parents prefer spread immunization into two separate visit. For each 1000
children, there are 20 children revisit the designated MCHC for immunization
The mean monthly salary of registered nurse in DH at Master Pay Scale point 19 is
$32560 per month. Having to work 44 hours per week and 4 weeks per month, the
hourly salary for registered nurse in MCHC is $32560/44/4 = $185 per hour (Civil
Service Bureau, 2015)
58
Appendix J
Grades of Recommendations
Grade Statements
A At least one meta-analysis, systematic review, or RCT rated as 1++, and directly applicable to the target population; or
A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating
overall consistency of results
B A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall
consistency of results; or
Extrapolated evidence from studies rated as 1++ or 1+
C A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency
of results; or
Extrapolated evidence from studies rated as 2++
D Evidence level 3 or 4; or
Extrapolated evidence from studies rated as 2++
(Scottish Intercollegiate Guidelines Network, 2014)
59
Appendix K
Evidence-based Practice Guideline
Background: Immunization is the most effective way in controlling, reducing and
eliminating infectious disease. However, immunization-induced pain leads to distress
to children, parents and health care provider, including needle phobia, nonadherence
to immunization schedule and conflict between parents and health care provider.
Through lots of scientifically proven pain management available, they are seldom
used as parents do not know them.
Clinical issue: To educate parents regarding the scientifically proven pain
management in order to empower parents managing immunization-induced pain
Title: An evidence-based parent-directed education program
Target users: All nurses responsible for interviewing parents before childhood
immunization in MCHC
Target group: Parents of children below 6 years old receiving immunization in
MCHC
Aim: To increase parents’ knowledge and utilization of scientifically proven pain
management during childhood immunization
Objectives:
1) To summarize the best available evidence on parental educational intervention
regarding pain management during childhood immunization.
2) To formulate clinical guideline in educating parents regarding pain management
strategy based on the best available evidence.
3) To standardize the process of educating parents regarding pain management
during childhood immunization in MCHC.
Evidence based recommendations
Recommendation 1
The education intervention should be delivered on the day of childhood
immunization.
(Grade of Recommendations: A)
Available evidence
a. Offering training program when parents and children were waiting for
immunization successfully increased the parental awareness of the downside of
undesirable parent procedural behaviors (Cohen et al., 2015). (1++)
b. There was acute knowledge gain in evidence-based pain management immediately
after reading the factsheet (Taddio et al., 2014c). (1++)
c. The use of pain interventions by parents increased on the day of education (Taddio
et al., 2015). (1++)
60
Recommendation 2
Parents should be directed to read or watch the education materials.
(Grade of Recommendation: B)
Available evidence
a. The impact of an instructional pamphlet was low when it was passively distributed
to the target population and without attention was drawn on it. However, the
impact of the pamphlet on knowledge gain and utilization of effective pain
management intervention would be significant if the target population had read it
(Taddio et al., 2014a). (1-)
b. Reminder was given to the research participants to review the educational material
before childhood immunization with significant increase in the use of evidence-
based pain management (Bustos et al., 2008; Taddio et al., 2015). (1+; 1++)
Recommendation 3
One-page pamphlet with picture and word description should be disturbed to parents.
(Grade of Recommendation: B)
a. A simple, low-cost printed material was feasible and useful to educate and change
the behavior of a wide range of audience and the impact to the workload of staff
was low (Bustos et al., 2008; Taddio et al., 2014a; Taddio et al., 2014c) (1+; 1-;
1++)
Recommendation 4
Ensuring parents do not miss the important message from the pain management video
by gathering parents to watch the video in the function room before vaccination.
(Grade of Recommendation: A)
a. Method engaging parents to watch the whole video ensured them do not miss the
relevant content (Cohen et al., 2015; Taddio et al., 2015). (1++; 1++)
Recommendation 5
Incorporating both pamphlet and video on the day of immunization.
(Grade of Recommendation: A)
a. Implementing both pamphlet and video in outpatient clinic significantly increased
the use of pain management by parents during childhood immunization (Taddio et
al., 2015). (1++)
61
Reference of Guideline:
Bustos, T., Jaaniste, T., Salmon, K., & Champion, G. D. (2008). Evaluation of a brief
parent intervention teaching coping-promoting behavior for the infant
immunization context: A randomized controlled trial. Behavior Modification,
32(4), 450-467.
Cohen, L. L., Rodrigues, N. P., Lim, C. S., Bearden, D. J., Welkom, J. S., Joffe, N. E.,
McGrath, P. J., & Cousins, L. A. (2015). Automated parent-training for
preschooler immunization pain relief: A randomized controlled trial. Journal of
Pediatric Psychology, 40(5), 526-534. doi: 10.1093/jpepsy/jsu162
Taddio, A., MacDonald, N. E., Smart, S., Parikh, C., Allen, V., Halperin, B., & Shah,
V. (2014a). Impact of a parent-directed pamphlet about pain management during
infant vaccinations on maternal knowledge and behaviour. Neonatal Network,
33(2), 74-82.
Taddio, A., Ipp, M., Vyas, C., Parikh, C., Smart, S., Thivakaran, S., … Shah, V.
(2014c). Teaching parents to manage pain during infant immunizations. Laying
the foundation for better pain management practices. Clin J Pain, 30(11), 987-
994.
Taddio, A., Parikh, C., Yoon, E. W., Sgro, M., Singh, H., Habtom, E., Ilersich, A. F.,
Riddell, R. P., & Shah, V. (2015). Impact of parent-directed education on parental
use of pain treatments during routine infant vaccinations: a cluster randomized
trial. Pain, 156(1), 185-191.
62
Appendix L
Knowledge Test
Please circle the correct answer
Answer Correct
Answer
(will not be
shown)
1. Giving sugar water can reduce pain and distress T/F True
2. Using medicines like acetaminophen (Tylenol,
Tempra), or ibuprofen (Advil, Motrin) can reduce pain
and distress
T/F False
3. Putting ice on the skin can reduce pain and distress T/F False
4. Breastfeeding can reduce pain and distress T/F True
5. Bottle feeding can reduce pain and distress T/F True
6. Holding the baby can reduce pain and distress T/F True
7. Distracting the baby can reduce pain and distress T/F True
8. Acting calm can reduce pain and distress T/F True
9. Rubbing the skin can reduce pain and distress T/F False
(Taddio et al., 2014a ; Taddio et al., 2014c)
63
Appendix M
Observation Form of Parental use of Scientifically Proven Pain Management
during childhood immunization
Scientifically proven
pain management
Timing Tick whenever
appropriate
Sugar Water Before injection
Breastfeeding Before injection
During injection
Bottle feeding Before injection
During injection
Holding Before injection
During injection
64
Appendix N
Self-developed Satisfactory Questionnaire
Please put a tick in the appropriate boxes below to indicate your view on the following statements:
Strongly
Agree
Agree
Neutral
Disagree
Strongly
Disagree
Content of video is clear, concise and precise
Content of pamphlet is clear, concise and precise
I understand more regarding evidence based pain management during
childhood immunization
I feel more confidence to manage child’s pain during immunization after
watching the video and/or reading the pamphlet
Nurses are supportive in the way of using evidence based pain management
during childhood immunization
The innovation meets my need
Additional comment:
65
Appendix O
Outline of the Semi-structured Meeting
Aim: Providing opportunity for frontline nurses to express feeling and opinion
regarding the innovation
Participants: All front line nurses
Discussion point
1. Impact of the innovation in daily work (positively and negatively)
2. Difficulties encountered during interview and immunization process (Can they
be solved? Whether nurses have control over the implementation?)
3. Suggestion for improvement
4. Other opinion
66
Reference
Bustos, T., Jaaniste, T., Salmon, K., & Champion, G.D. (2008). Evaluation of a brief
parent intervention teaching coping-promoting behaviour for the infant
immunization context: A randomized controlled trial. Behavior Modification,
31(4), 450-467.
Centers for Disease Control and Prevention (2012). Introduction to program
evaluation for public health programs: A self-study guide. Retrieved May 2,
2016 from http://www.cdc.gov/eval/guide/step1/
Centre for Health Protection (2010, April). Child health survey 2005-2006. Retrieved
October 17, 2015, from the World Wide Web:
http://www.chp.gov.hk/files/pdf/chs_eng.pdf
Civil Service Bureau (2015). Master Pay Scale. Retrieved February 10, 2016 from
http://www.csb.gov.hk/english/admin/pay/42.html
Cohen, L., Rodrigues, N. P., Lim, C. S., Bearden, D. J., Welkom, J. S., Joffe, N. E., …
Cousins, L. A. (2015). Automated parent-training for pre-schooler immunization
pain relief: A randomized controlled trial. Journal of Pediatric Psychology,
40(5), 526-534.
67
Department of Health (2015, September 30). Department of Health annual report
2011/2012. Retrieved October 17, 2015, from the World Wide Web
http://www.dh.gov.hk/english/pub_rec/pub_rec_ar/pub_rec_arpis_1112_html.htm
l
Family Health Service (2013). 80th anniversary of Family Health Service, Department
of Health. The Government of the Hong Kong Special Administrative Region:
Department of Health. Retrieved October 24, 2015, from the World Wide Web
http://www.fhs.gov.hk/english/archive/files/reports/DH_booklet_18-7-2013.pdf
Family Health Service (2014, February 24). Child Health. Retrieved October 17,
2015, from the World Wide Web:
http://www.fhs.gov.hk/english/main_ser/child_health/child_health.html
Government of Canada (2015). Immunize your child. Retrieved January 24, 2016
from http://healthycanadians.gc.ca/healthy-living-vie-saine/immunization-
immunisation/children-enfants/immunize-immuniser-eng.php#s5
Hodges, B. C., & Videto, D. M. (2011). Assessment and planning in health programs
(2nd ed.). Sudbury, MA: Jones & Bartlett Learning.
Koperski, M. (1989). Health education using video recordings in a general practice
waiting area: an evaluation. Journal of the Royal College of General
Practitioner, 39, 328-330.
68
Moher, D., Liberati, A., Tetzlaff, J., Altman, D. G., The PRISMA Group (2009).
Preferred reporting items for systematic reviews and meta analyses: The
PRISMA Statement. PLoS Med 6(6): e1000097.
doi:10.1371/journal.pmed1000097
Parvez, E., Stinson, J., Boon, H., Goldman, J., Shah, V., & Taddio, A. (2010).
Mothers’ beliefs about analgesia during childhood immunization. Paediatr Child
Health, 15(5), 289-293.
Polit, D. F., & Beck, C. T. (2012). Nursing research: Evidence for nursing practice
(9th
ed.). Philadelphia, PA: Lippincott Williams & Wilkins.
Primary Care Office (2015, June 8). Hong Kong Reference Framework for Preventive
Care for Children in Primary Care Setting. Retrieved October 18, 2015, from the
World Wide Web
http://www.pco.gov.hk/english/resource/professionals_preventive_children_pdf.h
tm
Schechter, N. L., Zempsky, W. T., Cohen, L. L., McGrath, P. J., McMurtry, C. M., &
Bright, N. S. (2007). Pain reduction during pediatric immunizations: evidence-
based review and recommendations. Pediatrics, 119(5), e1184-e1198.
Doi:10.1542/peds.2006-1107
69
Scottish Intercollegiate Guidelines Network (2012, May). Methodology checklist 2:
Controlled trials. Retrieved December 14, 2015, from
http://www.sign.ac.uk/methodology/checklists.html
Scottish Intercollegiate Guidelines Network (2014, October). SIGN 50: A guideline
developer’s handbook. Retrieved December 14, 2015 from
http://www.sign.ac.uk/pdf/sign50.pdf
Stalker, C., & Elander, J. (2015). Effects of a pain self-management intervention
combining written and video elements on high-related quality of life among
people with different level of eduvation. Journal of Pain Research, 8, 581-590.
Taddio, A., Chambers, C. T., Halperin, S. A., Ipp, M., Lockett, D., Rieder, M. J., &
Shah, V. (2009). Inadequate pain management during rountine childhood
immunizations: The nerve of it. Clinical Therapeutics, 31(Supplement B), S152-
S167.
Taddio, A., Ipp, M., Vyas, C., Parikh, C., Smart, S., Thivakaran, S., … Shah, V.
(2014c). Teaching parents to manage pain during infant immunizations. Laying
the foundation for better pain management practices. Clin J Pain, 30(11), 987-
994.
70
Taddio, A., MacDonald, N. E., Smart, S., Parikh, C., Allen, V., Halperin, B., & Shah,
V. (2014a). Impact of a parent-directed pamphlet about pain management during
infant vaccinations on maternal knowledge and behaviour. Neonatal Network,
33(2), 74-82.
Taddio, A., Manley, J., Potash, L., Ipp, M., Sgro, M., & Vibhuti, S. (2007). Routine
immunization practices: use of topical anethetic and oral analgesic. Pediatrics,
120(3), e637-643. DOI: 10.1542/peds 2006-3351.
Taddio, A., Parikh, C., Yoon, E. W., Sgro, M., Singh, H. Habtom, E., Ilersich, A. F.,
Riddell, R. P., & Shah, V. (2015). Impact of parent-directed education on parental
use of pain treatments during routine infant vaccinations: A cluster randomized
trial. Pain, 156(1), 185-191.
Taddio, A., Shah, V., Leung, E., Wang, J., Parikh, C., Smart, S., Hetherington, R., Ipp,
M., Riddell, R. P., Sgro, M. Jovicic, A., & Franck, L. (2013). Knowledge
translation of the HELPinKIDS clinical practice guideline for managing
childhood vaccination pain: usability and knowledge uptake of educational
materials directed to new parents. BMC Pediatrics, 13(23).
Taddio, A., Smart, S., Sheedy, M., Yoan, E. W., Vyas, C., Parikh, C., Riddell, R. P., &
Shah, V. (2014b). Impact of prenatal education on maternal utilization of
analgesic interventions at future infant vaccinations: a cluster randomized trial.
Pain, 155, 1288-1292.
71
Tuong, W., Larsen, E. R., & Armstrong, A. W. (2014). Video to influence: a
systematic review of effectiveness of video-based education in modifying health
behaviors. J Behav Med, 37, 218-233.
Wallace, A. S., Mantel, C., Mayers, G., Mansoor, O., Gindler, J. S., & Hyde, T. B.
(2014). Experiences with provider and parental attitudes and practices regarding
the administration of multiple injections during infant vaccination visits: Lessons
for vaccine introduction. Vaccine, 32, 5302-5310.
Waston J. (1985). Nursing the philosophy and science of caring. Boulder, Colorado:
University Press of Colorado.
Woodin, K. A., Rodewald, L. E., Humiston, S. G., Carges, M. S., Shcaffer, S. J., &
Szilagyi, P. G. (1995). Physician and parent opinions. Are children becoming
pincushions from immunizations? Arch Pediatr Adolesc Med, 149, 845-849.
World Health Organization (2013). Global vaccine action plan 2011-2020. The USA:
WHO Press. Retrieved October 15, 2015 from the World Wide Web:
http://www.who.int/immunization/global_vaccine_action_plan/GVAP_doc_2011
_2020/en/
World Health Organization, Regional Office for Eastern Mediterranean (2013). Health
education: theoretical concepts, effective strategies, and core competencies.
Cario, Egypt: Author.