i

Abstract of thesis entitled

“Evidence-Based Guideline for Using Ginger for Primary Dysmenorrhea”

Submitted by

WAI Ka Yan

for the degree of Master of Nursing

at The University of Hong Kong

in July 2016

In Hong Kong, the prevalence of dysmenorrhea is 69-80% as mentioned in

local studies. Primary dysmenorrhea is a common gynecological diagnosis

which means pelvic pain during menstruation without any pathological cause.

The unpleasant feeling affects the physical health and daily living of women and

causes absenteeism from work or school and even hospital admission. The

traditional pharmacological therapy had 20-25% of failure rate as reported from

some studies. The unwanted side effects from the medications also leaded to

poor compliance and made the treatment ineffective. Evidence suggested ginger

as an effective alternative therapy in pain reduction for primary dysmenorrhea

although it is not practicing in the target gynecology department. Five related

studies were recognized from a systematic search with translational review

ii

performed which showed ginger is effective in pain relief in primary

dysmenorrhea with statistical significance. Level of evidence and critical

appraisal were made according to the recommendation of the SIGN grading

system. Subsequently, an evidence-based guideline for using ginger for primary

dysmenorrhea is formulated after assessing the transferability and feasibility that

benefits offset the costs. Communication plan included all the stakeholders and

a pilot test were addressed prior to the full implementation of the innovation.

Finally, evaluation plan was made to estimate the effectiveness and satisfaction

in order to have improvement in the future development of the innovation.

iii

Evidence-Based Guideline for Using

Ginger for Primary Dysmenorrhea

by

WAI Ka Yan

B.Nurs. H.K.U.

A thesis submitted in partial fulfillment of the requirements for

the degree of Master of Nursing

at The University of Hong Kong

July 2016

iv

Declaration

I declare that this dissertation represents my own work, except where due

acknowledgement is made, and that is has not been previously included in a

theses, dissertation or report submitted to this University or to any other

institution for a degree, diploma or other qualifications.

Signed _______________________

WAI Ka Yan

v

Acknowledgements

I would like to express my deepest gratitude to my dissertation supervisor,

Dr. Elizabeth Hui, for her guidance, encouragement and support to make this

thesis possible.

I would like to extend my heartfelt thanks to all the staff in the School of

Nursing, the University of Hong Kong and colleagues in my department for

their continuous support during my two-year study.

It is an honor for me to have my classmates and friends who provided

constructive inputs and endless support to me.

Lastly, I am grateful to have masters and angels surrounding me especially

my idol and my love.

vi

Contents

Declaration--------------------------------------------------------------------------------iv

Acknowledgements------------------------------------------------------------------------v

Contents------------------------------------------------------------------------------------vi

Abbreviations-----------------------------------------------------------------------------vii

Chapter 1 Introduction

1.1 Background--------------------------------------------------------------------1

1.2 Affirming the Need-----------------------------------------------------------4

1.3 Objectives and Significance-------------------------------------------------8

Chapter 2 Critical Appraisal

2.1 Search and Appraisal Strategies--------------------------------------------11

2.2 Results-------------------------------------------------------------------------13

2.3 Summary and Synthesis-----------------------------------------------------18

Chapter 3 Implementation Potential and Clinical Guideline

3.1 Transferability----------------------------------------------------------------21

3.2 Feasibility---------------------------------------------------------------------27

3.3 Cost-Benefit Ratio-----------------------------------------------------------31

3.4 Evidence-Based Guideline-------------------------------------------------35

Chapter 4 Implementation Plan

4.1 Communication Plan--------------------------------------------------------36

4.2 Pilot Study Plan--------------------------------------------------------------42

4.3 Evaluation Plan---------------------------------------------------------------44

4.4 Basis for Implementation---------------------------------------------------48

Conclusion-------------------------------------------------------------------------------49

Bibliography References--------------------------------------------------------------50

Appendices

Appendix I PRISMA 2009 Flow Diagram--------------------------------------55

Appendix II Bibliographic Citation of Selected Studies-----------------------56

Appendix III Table of Evidence----------------------------------------------------57

Appendix IV SIGN Methodology Checklist and Grading System-------------60

Appendix V Cost-Benefit Ratio Calculation-------------------------------------65

Appendix VI Evidence-Based Practice Guideline--------------------------------67

Appendix VII Menstrual Pain Chart------------------------------------------------69

Appendix VIII Timeline for Implementation of the Innovation------------------70

Appendix IX Patient Satisfaction Questionnaire---------------------------------71

Appendix X Staff Satisfaction Questionnaire------------------------------------72

vii

Abbreviations

APN Advanced Practice Nurse

BMI Body Mass Index

COS Chief of Service

DOM Department Operation Manager

GM(N) General Manager (Nursing)

HCE Hospital Chief Executive

NSAID Non-Steroidal Anti-inflammatory Drug

RCT Randomized Control Trial

RN Registered Nurse

SPSS Statistical Package for Social Sciences

VAS Visual Analogue Scale

WHO World Health Organization

WM Ward Manager

1

CHAPTER 1

Introduction

Primary dysmenorrhea is the most common gynecology diagnosis. In Hong

Kong, pharmacological therapy is the first line treatment to primary

dysmenorrhea. However, different studies have evidence showed that

non-pharmacological therapy, like the use of ginger, has pain relief property and

is effective in primary dysmenorrhea patients. In this chapter, the background,

affirming needs, objectives and significance of using ginger as pain relief

method in primary dysmenorrhea would be addressed.

1.1 Background

Dysmenorrhea is the most common diagnosis in gynecology that also

called menstrual pain or menstrual cramps which means pelvic pain during

menstruation in women of all ages over the world (Osayande & Mehulic, 2014).

The primary dysmenorrhea is having pelvic pain during menstruation without

any pathological cause with onset usually starts at 6-12 months after menarche

and peak in late teens or early 20s (Osayande & Mehulic, 2014). Unmarried

women affected more than married women (Osayande & Mehulic, 2014). On

the other hand, secondary dysmenorrhea is menstrual pain caused by underlying

2

pathological reasons commonly due to endometriosis or uterine fibroid which

accounted for about 10% of whom with dysmenorrhea (Harel, 2006). The

prevalence rate of dysmenorrhea varies from 1.7% to as high as 97% (Latthe,

Latthe, Say, Gülmezoglu & Khan, 2006). In Hong Kong, the prevalence rate was

69% (Chan, Yiu, Yuen, Sahota & Chung, 2009) to 80% (Chia, Lai, Cheung,

Kwong, Lau, Leung, Leung, Wong & Ngu, 2013). Dysmenorrhea often causes

absenteeism from school or work which pointed out a great trouble in daily life

such as sleep disturbance, concentration ability and influence in normal physical

activity (Chia et al., 2013).

The increased production of prostaglandins and leukotrienes leads to

uterine contraction which could induce primary menstrual pain (Fraser, 1992).

The current practice for primary dysmenorrhea is the use of non-steroidal

anti-inflammatory drug (NSAID), oral contraceptive pills and other analgesic

(Daniels, Torri & Desjardins, 2005).

Ginger, species named as Zingiber officinale, is an important herbal

supplement with a long history of 2500 years of traditional usages especially in

painful diseases (Kizhakkayil & Sasikumar, 2011). Ginger had been classified in

the Food and Drug Administration of the United States as a “generally

recognized as safe” herb (Dermarderosian & Beutler, 2000). Ginger could

3

reduce the production of prostaglandins and leukotrienes which results in

effective on anti-inflammation and pain reduction (Van Breemen, Tao & Li,

2011).

4

1.2 Affirming the Need

Primary dysmenorrhea is not life threatening, but severe menstrual pain can

cause fainting. Menstrual pain could be steadily resolved over 12-72 hours

(Lentz, Lobo, Gershenson, & Katz, 2012). According to Chia et al. (2013), the

peak of menstrual pain is at the beginning of menstruation with average pain

score 5/10 in Visual Analog Scale (VAS) and 70% of the participants had regular

menstrual cycles. Besides hospital admission, about 19% of dysmenorrhea

patients need to sick leave from school or work in Hong Kong (Chia et al.,

2013). Severe pain also caused sleep disturbance, lowered concentration ability,

reduced physical activity, etc. (Chia et al., 2013). The prognosis of primary

dysmenorrhea depends on the successful of treatment. Consequently,

dysmenorrhea is accountable for a substantial economic loss attributable to the

costs of medical care, medications and reduced productivity.

In a gynecology department of one of the Hong Kong public hospitals,

primary dysmenorrhea is one of the significant diagnoses. Women sought

medical advice as out-patients, admitted as in-patients or even with repeated

admission. The hospital admission rate of the dysmenorrhea patients is 3% in

Hong Kong according to Chia et al. (2013). It is accounted for around 180

admissions per year in the designated department by observation. The

5

gynecology out-patient clinic often encountered patients who were suffering

from primary dysmenorrhea. From experience, roughly 300 cases per year

sought medical advice in the gynecology out-patient clinic of the selected

department directly or referred for follow-up from in-patients upon discharge for

primary dysmenorrhea. For both out-patients and in-patients, the first line

treatment is the pharmacological mean by prescribing chemical medication like

NSAIDs which usually referred to mefenamic acid and secondary by injecting

pain relieving medication such as tramadol in acute situation. There is a lack of

nurse directed intervention in cases with primary dysmenorrhea while nurses

could participant more in caring of primary dysmenorrhea patients.

Conversely, some studies reported the failure rate of the use of NSAIDs

and oral contraceptive pills is about 20-25% (Proctor, Smith, Farquhar & Stones,

2002). Gastrointestinal disorders like nausea, vomiting and dyspepsia are the

common unwanted side effects of NSAIDs which causing intolerance and made

the need from the medical practitioners to prescribe other medications to treat

the gastrointestinal symptoms. Besides, some people are even allergy to

NSAIDs. With direct observation in the gynecology department, it was found

that the contraindications and the unwanted side effects of NSAIDs made people

hesitate or even refuse to take the medication which leads to a poor compliance

6

and made the treatment ineffective. Therefore, there is increasing number of

people to seek for alternative management (Abdul-Razzak, Ayoub, Abu-Taleb

& Obeidat, 2010). But those alternative managements such as sleeping, taking

warm beverage, adjusting posture, using warm water bag were not very effective

as NSAIDs (Chia et al., 2013).

Ginger is inexpensive and regarded as a safe herb which had been proved

effective in many medical purposes like managing pain in osteoarthritis and

relieving nausea and vomiting (Kizhakkayil & Sasikumar, 2011). Ginger could

be taking into account in pain reduction in primary dysmenorrhea with the

reduction in the production of prostaglandins and leukotrienes feature (Van

Breemen et al., 2011). By reducing the synthesis of prostaglandin, it could also

be an anti-inflammatory agent (Grzanna, Lindmark & Frondoza, 2005).

Furthermore, the prevalence of using herbal supplements is highest among

Asians (30%) with the effect of ethnic background (Gardiner, Whelan, White,

Filippelli, Bharmal & Kaptchuk, 2013) that the self administration of ginger as

pain alleviating may be easier acceptable in the innovation. In Germany’s

Commission E Monograph, found ginger with no severe side effects reported or

drug interactions (Blumenthal & Busse, 1998). Ginger is also easily available

which may demonstrate as the first line therapy instead of those chemical

7

medications.

There are some systematic reviews about the effect of the use of ginger

such as for stomach upset and motion sickness, and also some systematic

reviews about pain management of primary dysmenorrhea. Nevertheless, there

is no published systematic review noted at the time of evidence searching in the

topic of the use of ginger as pain relieving method in primary dysmenorrhea

patients which indicate the need of a systematic review because it does not only

benefits the patients who are suffering from primary dysmenorrhea but also

lessen the burden of the health care system and economic lost due to

absenteeism from work.

A translational review should be conducted so as to develop an innovative

evidence-based guideline for primary dysmenorrhea patients with the use of

ginger as pain relieving method.

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1.3 Objectives and Significance

Objectives

The objectives of the thesis is to perform a comprehensive literature search

for the evidence of using ginger as pain relief method in primary dysmenorrhea

patients. And, it is aimed to discuss the effectiveness of using ginger as pain

relief method in primary dysmenorrhea patients. Another objective is to evaluate

of the feasibility of using ginger as pain relief method in the gynecology

department. Also, an evidence-based guideline on using ginger as pain relief

method in primary dysmenorrhea patients would be developed.

Research Question

How effective would the use of ginger be on pain reduction in primary

dysmenorrhea patients?

PICO Component

The population is primary dysmenorrhea patients who seek medical advice

in gynecology department with the use of oral ginger as the intervention to

compare with the control which is the use of placebo or with the use of NSAIDs.

And, the outcome measure is the pain level.

Hypothesis

The tested hypothesis is whether ginger is associated with pain relief in

9

primary dysmenorrhea.

Significance

Dysmenorrhea affects the society which could cause a loss of $600million

working hours and $2billion per year in United States due to the absenteeism

from work (Doty & Attaran, 2006). Most people suffering from primary

dysmenorrhea start with self management of the symptoms (Chia et al., 2013).

Yet, self management of primary dysmenorrhea like using hot pad, drinking

warm beverage, sleeping, adjusting postural may not be effective (Chia et al.,

2013). These then initiate the seeking of medical advices with the help of

chemical medications. However, chemical medications are not preferred due to

the unwanted side effects and the intolerance. New innovation with effective and

little negative effects method should be introduced for the people who suffering

primary dysmenorrhea.

As primary dysmenorrhea usually affects women at age 20s (Osayande &

Mehulic, 2014) that they are still at school or just entered the labor force. In

minimizing the pain during menstruation, the innovation of using ginger as pain

relieving method could benefit the quality of life of the patients physically and

psychologically by symptoms alleviating so that patients could continue their

daily living without disturbance by the menstrual pain. To the society, beneficial

10

is made to the public health and the economy by reducing the recurrent

short-term work or school absenteeism.

Last but not least, minimizing the side effects of the treatment could change

the health seeking behavior. People would have courage to seek proper medical

advice by reducing the fear of the use of chemical medications (Chan et al.,

2009). An early starts of an effective treatment could reduce the need of hospital

admission and lower the repeated admission rate.

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CHAPTER 2

Critical Appraisal

Systematic searching and appraising strategies are needed to identify

relevant data and useful information from various literatures. Results, summary

and synthesis of the literature searching would be reviewed in this chapter.

2.1 Search and Appraisal Strategies

Search strategy

Literature searching of relevant studies through electronic databases was

performed from April to June 2015. Three chosen electronic databases are

PubMed, CINAHL Plus and the Cochrane Library. The keywords used in all

three electronic databases are dysmenorrhea, menstrual pain, ginger and

Zingiber Officinale. After searching the keywords, results were limited to

English or Chinese and clinical trial. Then screening of the title and abstract was

performed according to inclusion and exclusion criteria. Also, manual searching

was performed by searching the reference list of the related studies.

Inclusion criteria

For the Participants, all women with primary dysmenorrhea could be

included in the searching strategy. The use of ginger as per oral pain relieving

12

method would be the only intervention. Any comparison to placebo and/or

NSAID could fulfill the inclusion criteria. And the type of outcome measure was

the pain level.

Exclusion criteria

Cases with secondary diagnosis would be excluded in the searching.

Appraisal strategy

Each selected studies were made into a table of evidence for comparing

data among the selected studies as in Appendix III by using bibliographic

citation, study design, study quality, sample characteristics, intervention, control,

outcome measure and effect size.

The Scottish Intercollegiate Guidelines Network (SIGN, 2015)

methodology checklist for controlled trails was used as quality assessment for

all the selected studies. And the SIGN grading system 1999-2012 was used as

recommended for grading the level of evidence which has been attached in

Appendix IV.

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2.2 Results

With the use of keywords dysmenorrhea OR menstrual pain AND ginger

OR Zingiber Officinale, there were total of 26 results available from the three

electronic databases which included 16 from PubMed, 2 from CINAHL Plus and

8 from the Cochrane Library. After the removal of duplicated studies, there were

16 studies left. According to inclusion and exclusion criteria and limited to full

text, 5 clinical trial studies were included finally. The search results were

presented in the PRISMA flow chart which was attached as Appendix I.

The five studies were as follow: Jenabi (2013); Kashefi, Khajehei, Cher,

Alavian & Asili, (2014); Marjan, Narges & Abbas (2015); Rahnama, Montazeri,

Huseini, Kianbakht & Naseri (2012); and Ozgoli, Goli & Moattar (2009). The

bibliographic citation of the selected studies was detailed in Appendix II.

The selected studies were clinical trials that published from 2009-2015 and

were all written in English. All were one site studies expect Kashefi et al. (2014)

which was a multicentre study. Three studies had one intervention group and

one control group while Kashefi et al. (2014) and Ozgoli et al. (2009) were 3

arms control studies.

All the five studies had comparable characteristics between groups. Among

the five selected studies, participants were aged above 18 and with no upper age

14

limit during recruitment except Kashefi et al. (2014) which only recruited 15-18

years old participants. Two studies mentioned the participants recruited were all

single (Jenabi, 2013 & Rahnama et al., 2012) while the other three did not

mentioned the marital status.

All the participants in the five studies were suffered from moderate to

severe primary dysmenorrhea (Rahnama et al., 2012 & Ozgoli et al., 2009),

primary dysmenorrhea with VAS >4/10cm (Kashefi et al., 2014 & Marjan et al.,

2015) and primary dysmenorrhea with VAS >3/10cm (Jenabi 2013) without

taking any hormones especially contraceptive pills or with any other secondary

diagnoses. Besides, extreme Body Mass Index (BMI) such as >26kg/m² were

excluded in studies (Rahnama et al., 2012 and Ozgoli et al., 2009) as their

dysmenorrhea may be due to other influencing factors.

In addition, all the five studies compared the use of ginger powder capsule

to placebo or NSAIDs. Jenabi (2013) gave 500mg 3 times a day in the first 3

days of menstrual cycle. Kashefi et al. (2014) gave 250mg 3 times a day in the

first 4 days of menstrual cycle for 2 cycles. Marjan et al. (2015) gave 250mg

every 6 hours from the onset of menstruation till no more pain for 2 cycles.

Rahnama et al. (2012) gave 500mg 3 times a day 2 days before menstrual cycles

till day 3 of menstruation in protocol 1 and during the first 3 days of menstrual

15

cycle in protocol 2. Ozgoli et al. (2009) gave 250mg 4 times a day for the first 3

days of menstrual cycle.

For the control group, Jenabi (2013) and Rahnama et al. (2012) gave

placebo for comparison. Kashefi et al. (2014) was compared to placebo and

another arm to zinc sulfate. Marjan et al. (2015) was compared with the usual

care which is a NSAID also in capsule form called mefenamic acid. Ozgoli et al.

(2009) was compared with the usual NSAID care which included mefenamic

acid in capsule form and ibuprofen in tablet form.

All five studies showed statistically significant (p<0.05) that ginger is

effective for pain relieving in primary dysmenorrhea compared to placebo and

same effect as NSAIDs. Marjan et al. (2015), Rahnama et al. (2012) and Ozgoli

et al. (2009) measured the pain intensity before and after the menstrual cycle

while Jenabi (2013) and Kashefi et al. (2014) measured every day during

treatment. Jenabi (2013) had the effect size of 3.33cm reduction in VAS

(p=0.001). Kashefi et al. (2014) had the effect size of 0.93cm reduction in VAS

in the first month and 3.87cm reduction in VAS in the second month (p<0.001).

The effect size of Rahnama et al. (2012) was 1.28cm mean reduction in VAS in

protocol 1 (p=0.015) and 1.21cm mean reduction in VAS in protocol 2

(p=0.029). Marjan et al. (2015) and Ozgoli et al. (2009) showed no significant

16

difference in pain level compared to NSAID groups (p<0.05). All the selected

studies showed pain reduction and no statistically difference in adverse effect

with the use of ginger compared to other groups.

All the subjects of the selected studies were recruited by using convenience

sampling. And then participants were randomly assigned into intervention and

control group except Ozgoli et al. (2009) which assigned participants alternately

into groups. Only Jenabi (2013) and Kashefi et al. (2014) used random table to

minimize bias while the other two studies did not specified. For allocation

concealment, Jenabi (2013) concealed with envelop, Kashefi et al. (2014) and

Ozgoli et al. (2009) used coded method while the other two studies did not.

Only Rahnama et al. (2012) and Ozgoli et al. (2009) were double blinded but

others were all single blinded. The sample size of the five studies ranged from

70 to 150 with a total of 600 participants involved and all had informed consent.

All five studies had comparable groups and treatment was the only different that

the participants had similar baseline characteristics. There were four out of the

five selected studies used VAS as outcome measure which is a valid and reliable

tool but Ozgoli et al. (2009) did not. The drop-out rate is acceptable in all the

five studies that the maximum drop-out rate was 12.4% in total (Rahnama et al.

2012). Only three studies which were Marjan et al. (2015), Rahnama et al. (2012)

17

and Ozgoli et al. (2009) had intention to treat. For the only multicentre study,

Kashefi et al. (2012) didn’t compared results from all sites.

All five studies had overall effect due to intervention alone and the results

were applicable to the target group. Jenabi (2013) and Kashefi et al. (2014) had

high quality in minimizing the risk of bias while Marjan et al. (2015) and Ozgoli

(2009) just had low quality. Rahnama et al. (2012) is acceptable in minimizing

the risk of bias. According to the SIGN Methodology Checklist, the level of

evidence of Jenabi (2013); Kashefi et al. (2014); and Rahnama et al. (2012)

were 1+ and Marjan et al. (2015) and Ozgoli et al. (2009) were 1-.

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2.3 Summary and Synthesis

All the five selected studies used ginger powder capsule as the intervention

for pain relieving in primary dysmenorrhea cases but there was diversity in the

control group between studies. There were three studies (Jenabi, 2013; Kashefi

et al., 2014; & Rahnama et al., 2010) used ginger to compare with placebo

showed statistically significant in menstrual pain reduction and the other two

studies (Marjan et al., 2015; & Ozgoli et al., 2009) used NSAIDs as the

comparing group showed ginger as effective as NSAIDs in menstrual pain

reduction. All the five studies consistently support the use of ginger powder

capsule in primary dysmenorrhea patients as pain alleviating agent. Though, it

seems to be more ideal to compare the use of ginger to the current practice

which is the use of NSAID instead of a placebo because ginger may be effective

but not as effective as the current practice.

Furthermore, the five selected studies also had a consistent target setting.

Participants were all recruited as out-patients only that the participants received

the ginger powder capsules from the hospitals and took the ginger powder

capsules by themselves at home (Jenabi, 2013; Kashefi et al., 2014; Marjan et al.,

2015); Rahnama et al., 2012; & Ozgoli et al., 2009).

VAS is a reliable measurement tool which is valid and widely used

19

(Williamson & Hoggart, 2005). There were four studies used VAS as outcome

measure in measuring the pain intensity while Ozgoli et al. (2009) used verbal

multi-dimensional scoring system and Jenabi (2013) used Likert Scale in

addiction to VAS for the pre and post treatment response.

As mentioned by the studies, ginger had lower level of side effects than

NSAIDs (Kashefi et al., 2014) and it is safe that there were no significant

differences in adverse effects noted (Rahnama et al., 2010). Jenabi (2013) also

showed that the ginger group rated 35.8% (p=0.001) more in pain improvement

than the placebo group. However, there were not severe but some minor adverse

effects were pointed out in some of the selected studies. Marjan et al. (2015)

mentioned the ginger group reported a prolonged duration of menstruation

within group (p=0.001) and between group (p=0.003) though it was not

significantly difference between groups over time. Although the menstrual

length was longer in ginger group, there was no statistically significant change

in bleeding amount, volume and length of pain (Marjan et al., 2015) which

means that it is not a serious adverse effect of using ginger during menstrual

period as pain relieving method. In addition, Kashefi et al. (2014) found ginger

is statistically effective in reduction of menstrual blood flow. For the adverse

effects measured, Rahnama et al. (2012) showed only 5.1% in the ginger group

20

had reported heartburn that it was not statistically significant compared to the

placebo group. Kashefi et al. (2014) told adverse effects included headache and

heartburn mentioned by two subjects during the first month and three in the

second month but it is also not statistically significant between groups (p=0.85).

Ginger only caused minor adverse effects which is much better than the current

treatment with the use of NSAIDs.

Overall, all of the five selected studies provided adequate evidence in

supporting the innovation of using ginger as a safe and inexpensive pain

alleviating method in primary dysmenorrhea cases with acceptable technique in

minimizing the risk of bias with level of evidence ranged from 1+ to 1-.

In conclusion, the innovation by using ginger as a pain relieving method in

primary dysmenorrhea patients has been supported by various evidences

consistently with a low degree of diversity. Owing to the lack of effective

method and specific guideline in pain relieving other than the use of pain killers

in treating primary dysmenorrhea, it is essential to have an innovation.

Additionally, after synthesized the information from the five selected studies, it

is transferable and feasible to develop a comprehensive evidence-based

guideline in the target local setting.

21

CHAPTER 3

Implementation Potential and Clinical Guideline

The selected studies recommended the use of ginger for pain relief for

primary dysmenorrhea patients. In this chapter, the potential of implementation

of the proposed innovation in the target setting would be discussed. The

transferability of findings, feasibility of initiating the innovation, cost-benefit

ratio of implementing the innovation would also be assessed. Besides, an

evidence-based guideline would be developed based on the selected studies.

3.1 Transferability

Target Setting and Target Population

The target setting of the evidence based guideline is one of the gynecology

departments in the public hospitals under the Hospital Authority in Hong Kong.

There are 17 hospitals under the Hospital Authority provide gynecological

services (Hospital Authority, 2014). The target setting provides both in-patient

and out-patient services for women who suffered from different gynecological

conditions includes primary dysmenorrhea. Gynecology out-patient services

could be referred by general practitioners, general out-patient department, or

accident and emergency department. For the in-patients, they will continue to

22

follow up in the gynecological out-patient clinic after being discharged. Each of

the patients who attend gynecological services will have an ultrasound scan

performed by gynecologist to rule out underlying causes if it is needed. To

facilitate the innovation, the patients would meet the nurse in the nurse-led day

centre. The nurse-led day centre which is currently used for different

pre-operation education and post-hysterectomy rehabilitation group. The

nurse-led day centre consists of computers, projector and other equipments for

nurses to meet their clients. The nurses only meet pre-operation patients in the

afternoon from Monday to Friday and post-hysterectomy patients once a month

on Saturday.

The target population is those who attended the gynecology ward and the

gynecology out-patient clinic of the target setting. Patients who have regular

menstrual cycles but suffered from primary dysmenorrhea with moderate to

severe pain that pain score >3 out of 10cm under the VAS and free from other

medical disease are the target population. Further assessment on BMI,

pregnancy history, health condition would be made before they participate in the

innovation.

Transferability in the Target Setting

23

Similarity of the Target Setting and Population

Both target setting and target population were similar to the five selected

studies. All the selected studies (Jenabi, 2013; Kashefi et al., 2014; Marjan et al.,

2015; Rahnama et al., 2012; and Ozgoli et al., 2009) were conducted in

out-patient setting that is same as the target setting which is the nurse-led day

centre of the gynecology department. For the population of the selected studies,

all the studies recruited women suffered from primary dysmenorrhea with

moderate to severe pain or with VAS =/>3cm which is same as the target

population. All the subjects in the selected studies sharing similar characteristics

compared to the target population: no history of pregnancy, BMI ranged from

19-25, with regular menstrual cycle, no hormones usage or having other

secondary diseases. Four of the studies found ginger is effective with selected

subjects over 18 years old with no upper limit (Jenabi, 2013; Marjan et al., 2015;

Rahnama et al., 2012; and Ozgoli et al., 2009) while one studies limited age to

15-18 years old (Kashefi et al., 2014) which means age did not affect the

effectiveness so there are no age limit in the target population.

Philosophy of Care

By sharing similar philosophy of care, the transferability of the innovation

would be enhanced.

24

“People-first” is the main philosophy of care of the Hospital Authority.

With the mission of helping people stay healthy, the Hospital Authority has the

values that provide patient-centered care with professional service to understand

and meet patients’ needs. Using ginger as an alternative pain relief method could

reduce both the physical discomfort and the unwanted side effects caused by

medications so as to improve the health and quality of life of the primary

dysmenorrhea patients.

For the philosophy of care of the target hospital, it intends to heal the sick

and to relieve the distressed. The target hospital has the mission of providing

medical services free of charge and expanding medical services such as to

integrate Chinese and Western medicine treatment. Ginger is an ingredient

generally used in Chinese cuisine. In the target hospital, the Chinese Medicine

Department would add ginger into their medicine in some situations such as

patients with nausea and vomiting. The most important is ginger had been

classified as “substance generally recognized as safe” (US Food and Drug

Administration, 2016). In this evidence-based guideline, ginger is used in the

western medicine part to help patients who suffered from menstrual pain.

In the gynecology department of the target hospital, the philosophy of care

is to provide people-centered safe and evidence-based care. The use of ginger as

25

a pain relief method for women with primary dysmenorrhea is evidence-based

according to the selected studies. And, ginger is safe that it has only few mild

negative side effects which had been shown by the selected studies.

Having similar philosophy of care makes the proposed innovation transferable

in the target setting.

Clients Benefited

A sufficiently large number of patients in the target setting could get benefits

from the innovation. According to the direct observation made in the target

department, around 30 patients admitted over the past one year with dysmenorrhea

as chief complaint. However, in-patients with other chief complaints may also

complaining moderate to severe dysmenorrhea at the same time during the

admission assessment. The rate was as high as around 150 patients per year but they

may only seek medical advice from general practitioners previously. If all the

patients complaining with dysmenorrhea fit the criteria of the target population,

approximately 180 patients could be benefited per year.

Implementation and Evaluate Time

After receiving all the approval of the innovation from the target department,

the preparation phase would begin and then followed by implementation and

evaluation phase. For the preparation period, it takes around two month time to

26

prepare the materials included the information sheet and the menstrual pain chart,

train the staff and prepare ginger capsules. A pilot program last for two months

would then be followed. An evaluation would go after so as to make adjustment

based on the comments about the pilot program. After that, full program of the

innovation would be carried out. Evaluation would be made every 6 months

continuously.

27

3.2 Feasibility

Freedom to Implement

Nurses have the freedom to carry out and terminate the innovation. Once

the nurses found the case is considered ineffective in the innovation, the nurse

could terminate the innovation and refer the case back to the out-patient clinic

for follow up. Also, nurses who were not yet assigned in other teams could join

the innovation according to their wish. And, the participating nurses could feel

free to quit the innovation once they found they are not competent in carrying

out the innovation or even due to their own personal reason.

Interference of Current Staff Function

The nursing manpower in the target department is fairly enough. Three

nurses are needed to participate in the innovation preferably that the current staff

function may be interfered in certain extent. Official hours should be provided

for the nurses who involved in the program to have related training. The three

nurses will take turn to run the innovation. One nurse is needed to interview and

follow up the patients by providing education, information, counseling and

evaluation once a week to meet up the needs of the target population. Therefore,

one extra nurse is needed one day per week that it may not be easy to release

28

manpower from the current staff.

Administrative Support

The target department support patient-centered evidence-based practice

which keeps up with the pace of time. New innovations that could provide safe

care to patient keep carrying out in the department. Supports from other

departments such as Pharmacy and Chinese Medicine Department are needed

for the preparation of the ginger capsule and staff training respectively.

Consensus

Use ginger as pain relief is evidence based but any innovation could cause

extra workload to the current staff in the target setting as extra time are needed

to have training, preparation and to familiarize with the new guideline. The

benefits from the innovation hope to offset the extra workload caused. Some

nurses and physicians in the target setting had already got a brief idea of the

innovation during staff lunch gathering and all sound support towards the

innovation.

Friction

The innovation may cause friction among nursing staff in the target setting

29

because extra manpower is needed to run the innovation. Barriers may be raised

by the medical officers because they may not accept the alternative therapy

although the target setting has integrated therapy which involved Chinese and

Western medicine treatment at the same time. Besides the target department,

friction from other departments may also be raised. Support and cooperation

from other departments is definitely needed especially manpower supported

from the Pharmacy for ginger capsule preparation and the Chinese Medicine

Department for the sharing of machines and techniques to chop and ground the

ginger.

Staff Development

Staff training is needed in order to implement the innovation successfully.

Currently, the target setting is using a menstrual chart to chart the menstrual

amount. The use of the renewed the menstrual chart to a menstrual pain chart

with the use of VAS is needed to introduce to the staff. At the same time,

education talks about the manifestation of ginger should be provided to the

related staff.

Equipment and Facilities

Suitable equipment and facilities could facilitate the innovation. Ginger is

the key element needed in this innovation. Machines which can ground the

30

ginger into ginger powder are needed. Afterwards, the ginger capsules could be

provided by the Pharmacy to the patients. Both ginger and machines are

available in the Chinese Medicine Department but extra amount of these items

are needed due to the increase in demand. Nevertheless, menstrual pain chart,

leaflet about the use of ginger and menstrual pain relief, and poster about the

innovation are needed to promote and run the innovation.

Evaluation Tool

The pain level of the patients would be assessed by using the VAS. With

the use of menstrual pain chart, patients need to mark the daily pain level on the

chart according to the days of their menstrual period. VAS is an appropriate

measuring tool for pain in the clinical evaluation of the innovation.

31

3.3 Cost-Benefit Ratio

Risk to Clients Exposed to Innovation

One of the selected studies mentioned some participants complained of

prolonged duration of period compared to the control group which used

mefenamic acid (Marjan, 2015)

Potential Benefits from Innovation

According to the selected studies, the use of ginger reduced the pain level

of dysmenorrhea patients and had little adverse effect especially compared to the

use of mefenamic acid. Once pain relieved, medical expenditure included

readmission cost and doctors’ consultation cost could be reduced. And,

manpower included nurses, doctors and pharmacists needed in patients cares

could be lowered. Also, the quality of life of the affected patients could be

enhanced.

Risks of Maintaining Current Practice

The current practice to treat moderate to severe primary dysmenorrhea is

the use of NSAIDs which usually is mefenamic acid. NSAIDs are advised to

take with food as the common side effects included gastrointestinal upset and

diarrhea since it is absorbed in the gastrointestinal tract rapidly (MIMS, 2016).

Due to the failure rate and unwanted side effects, the compliance of the use of

32

mefenamic acid was not good enough which leads to a high rate of repeat

attending the medical services. In addition, some patients even complaining the

current regime cannot relief their pain which made them absent from work or

school.

Material Costs of Innovation

The material costs could be developed into two types which are paper work

and the ginger capsule. For the paper works, information leaflet costs HK$0.5

each; menstrual pain chart costs HK$0.5 each; poster promoting the innovation

costs HK$1 each; assessment form costs HK$0.5 each; and evaluation form

costs HK$0.5 each. For the ginger capsule, ginger costs HK$20 per KG; a

drying machine costs HK$2500; a grinding machine costs HK$2500; empty

capsule costs HK$0.01 each. Appendix V has the details of the costs of the

innovation.

Material Costs of Not Implementing Innovation

If not implement the innovation, the major cost would be the substitute

which is the mefenamic acid that costs HK$0.1812/250mg capsule (usual dose

is 500mg three times a day for three days). At the same time, physicians

prescribe mefenamic acid together with an antacid called lantacid which costs

HK$0.0885/tablet (usual dose is one tablet three times a day for three days) to

33

relieve the side effect of mefenamic acid like heartburn. And, the cost for the

consultation time and the cost of readmission are counted. Appendix V has the

details of the material cost of not implementing the innovation.

Potential Nonmaterial Costs of Innovation

Apart from the material costs, there are some potential nonmaterial costs of

the innovation. The major nonmaterial cost would be the staff development cost

included training and education provided to the staff involved in the innovation

which takes four hours per course and the speakers are registered nurses and

Chinese Medicine practitioners. Besides, the cost of the nurses involved in

assessing, educating and evaluating patients is part of the nonmaterial costs. It is

estimated that a nurse needs to spend around 20 minutes on each patient per visit.

Every patients need to meet the nurse before and after the use of ginger.

Approximately one registered nurse is needed in the clinic once a week to

interview patients. Furthermore, pharmacists are needed for the ginger

processing and dispensing. The details of the nonmaterial costs were listed in

Appendix V.

Potential Nonmaterial benefits of the Innovation

For nurses, as the innovation is initiated by nurses, the job satisfaction

would be increased by helping patients with their autonomy. For doctors, their

34

workload would be relieved as the cases are shared by nurses and they could

spend much more time for other cases. For the pharmacists, their workload

would also be relieved because the time used to manage the chemical

medications should be longer than ginger. For management, reduced admission

rate and out-patients consultations, the resources could be reallocated to others

in necessity. The details of nonmaterial benefits had been mentioned in

Appendix V.

35

3.4 Evidence-Based Practice Guideline

An evidence-based guideline of using ginger as pain relieving method in

primary dysmenorrhea patients is developed based on the five selected studies

mentioned in the previous chapter (Jenabi, 2013; Kashefi et al., 2014; Marjan et

al., 2015; Rahnama et al., 2012; and Ozgoli et al., 2009). The details of the

guideline were attached as Appendix VI.

36

CHAPTER 4

Implementation Plan

The plan for implementation included the communication plan, pilot study

test, evaluation plan and the implementation basis would be explored to

facilitate an effective implementation of the innovation.

4.1 Communication Plan

An effective communication plan by addressing all levels of stakeholders

with a well-formed communication working team can promotes efficiency as a

result of reducing the friction of the innovation.

Stakeholders

Managerial level

The Chief of Service (COS), the Department Operation Manager (DOM)

and the Ward Manager (WM) from the selected gynecology ward of the public

hospital are included in the managerial level of the stakeholders. They involved

in the final decision making and allocation of resources included money and

manpower. Approval and support are needed from them so as to carry out the

proposed innovation. A comprehensive proposal of the innovation with the

affirming needs and the cost and benefit would be listed out and presented to

37

them.

Administrative level

The Hospital Chief Executive (HCE) and the General Manager (Nursing)

(GM(N)) of the selected hospital would be included as they responsible for the

administration of the hospital. They should be informed and endorsement should

be granted from them after getting the approval from the managerial level.

Operational level

The frontline staff of the selected gynecology department included medical

officers, Advanced Practice Nurses (APN) and Registered Nurses (RN) and

pharmacists were included in this level as they are the users of the proposed

innovation.

For nurses, they are the main users with autonomy to carry out and

terminated the proposal innovation to patients. To smooth the implementation,

nurses must be well equipped before the implementation and their concerns

must be voiced out and being considered.

For medical officers, they are responsible for the referral of suitable

patients to nurses in order to carry out the proposed innovation. The use of

ginger in dysmenorrhea is a new concept to the medical officers. They must be

well informed and their opinions must be fully addressed.

38

For pharmacist, they are involved in the ginger powder capsule making

which is an important part of the proposed innovation. Their concerns should

also be considered and their support is important.

Communication Process

First, the innovator would give a brief introduction of the proposed

innovation to the WM of the gynecology ward face-to-face individually to gain

the approval before any start. The WM has experience about the feasibility and

power to grant the approval of any new innovation. Amendment of the proposed

innovation could be made according to the meeting with the WM. After

approved by the WM, a communication working team would be formed prior to

the start of the communication process with different stakeholders. One of the

APNs of the gynecology ward would be the representative of the

communication working team for the overall coordination. And, two RNs of the

gynecology ward included the innovator would also be in the team. Also, one

pharmacist is also being included in the team. The innovator will share the

information of the innovation with the team. The team would be in-charge for

the preparation, staff training, implementation and evaluation during the whole

innovation. To facilitating the proposed innovation, the team would ensure the

39

communication between different departmental staff is effective.

For the initiation phase, the APN of the communication working team

would give a PowerPoint presentation of the proposed innovation included

affirming needs, aims and objectives, evidence and cost and benefit to the

stakeholders of the managerial level during the monthly departmental meeting in

order to gain the approval. The proposed guideline and the logistics would be

provided to them during the meeting too. The COS, the DOM and the WM have

the authority to approve any new innovation and reallocate the resource of the

ward. One month would be allowed to get feedbacks and recommendations from

them and to revise the proposed innovation. The revised proposal would then be

made and sent to the stakeholders via the intranet by E-mail to get further

endorsement. Once approval is granted from the managerial level, the finalized

proposal of the innovation would be sent to the stakeholders of the

administrative level to gain the support from the HCE and the GM(N). After that,

all the materials needed in the innovation, such as ginger, capsule and machines,

would be started to purchase and prepare.

For the guiding phase, two identical sessions of introduction meeting about

half an hour each would be provided to the frontline staff, included doctors,

nurses and pharmacists, with written information provided. Information about

40

the affirming needs, evidence of the use of ginger, cost and benefit and the

guideline would be presented to the staff with PowerPoint slides. A question and

answer session would be included in the end of the meeting for them to rise out

their concerns. E-mail and posters would be sent via intranet and posted up in

ward and pharmacy in order to raise the rate of participation of the staff one

week before the meeting.

For the staff training, two identical sessions of training workshop organized

by the communication working team with the collaboration of the Chinese

Medicine practitioner from the Department of Chinese Medicine of the selected

hospital would be provided. The workshop included the manifestation of ginger,

the use of the guideline and the logistic of the innovation. Not only the nurses

who responsible for the cases follow up but all the nurses of the department are

welcomed. Certificate of attendance would be issued at the end of the workshop

for proving as a service provider of the innovation. Study hours would also be

granted by the department.

Comments and feedbacks from colleagues will be reviewed for the revision

of the guideline. After the training sessions and revised the guideline, a pilot test

will be started.

For the sustaining phase, communication and feedback updates are

41

important. Supports to the colleagues from the communication working team

would be offered throughout the innovation. Continuous feedbacks, discussions

and recommendations are welcomed from all the stakeholders to the

communication working team by E-mail or face-to-face. As only three nurses

would be responsible for the cases follow up, sharing session among them

would be arranged monthly to share the difficulties they came across and the

successful cases they met so as to remove the obstacles. Also, regular updates

from the representative of the communication working team to the WM would

be made monthly. Amendment would be made from time to time based of the

recommendation of the stakeholders or due to the update of evidences. Any

changes of the guideline would be informed by the communication working

team via E-mail and during the hand over time. Furthermore, an annually

evaluation about the effectiveness and efficacy of the innovation would be

carried out and reported during the departmental meeting by the representative

of the communication working team.

42

4.2 Pilot Study Plan

A pilot study would be performed prior to the full implementation of the

proposed innovation.

The objectives of the pilot study are to ensure the feasibility of the

innovation and recognize the potential obstacles for the modification of the

evidence-based guideline according to the findings.

A two month period pilot study would be carried out in the selected

gynecology ward. Total 20 patients fulfilled the selection criteria mentioned in

Chapter 3 would be recruited by convenience sampling. One education session

and one follow up session would be given to each of the recruited patients.

The communication working team would manage the pilot study according

to the proposed guideline. The frontline staff included medical officers, nurses

and pharmacists would be informed two weeks before the start of the pilot study.

Consent form and educational leaflet would be given to the participants for

recruitment and education. Education session would be repeated twice a week

but feasible to the number of patients recruited and the follow up session would

be one month after the education session.

Evaluation according to the objectives of the pilot study would be

performed in the end of the pilot study. Evaluation meeting among the medical

43

officers, nurses and pharmacists who involved in the pilot study would be held

after the pilot study with the communication working team to collect feedbacks

regarding the feasibility of the innovation. Feedbacks from all the colleagues

even though they did not directly involve in the pilot study are also welcomed at

anytime through E-mail or face-to-face individually if they wanted. Refinement

of the evidence-based guideline would be made according to the evaluation

result. The refined guideline would be submitted to the WM afterwards. The full

scale innovation would be implemented with the estimated timeline has been

showed in Appendix VIII.

44

4.3 Evaluation Plan

A systematic evaluation can assess the effectiveness of the innovation and

sustain subsequent improvement.

Outcome evaluation

Patient outcome evaluation

The primary outcome of the proposed innovation is to reduce pain level

during menstruation. The pain level would be measured prior to the innovation

as baseline measurement and every menstrual period involved in the innovation.

The pain level would be marked by patient themselves on a menstrual pain chart

as showed on Appendix VII. The VAS measured from 0-10cm would be chose

as the measurement tool because four out of the five selected studies were also

used VAS (Jenabi, 2013; Kashefi et al., 2014; Marjan et al., 2015; and Rahnama

et al., 2012). Besides, VAS is the most frequently used measuring scale in pain

related endometriosis like dysmenorrhea (Bourdel, Alves, Pickering, Ramilo,

Roman, and Canis 2014). Apart from pain level, a questionnaire would be given

to patients recruited during the follow up sessions, every two months, to collect

feedback and assess the level of satisfaction with the 5-point Likert Scale as

showed in Appendix IX. Likert Scale was also used in two of the five selected

studies to measure the satisfactory level (Jenabi, 2013 and Ozgoli et al., 2009).

45

Health care provider outcome evaluation

In order to ensure the efficacy of the innovation, the level of satisfaction,

confidence in implementing the evidence based guideline and an increase in

knowledge of the health care providers should also be evaluated. An evaluation

questionnaire would be distributed to the staff during the evaluation period,

every six month apart, as showed in Appendix X.

System outcome evaluation

An effective innovation would be appreciated by the department and could

maintain the innovation in long run. A reduction in admission rate which then

reduces the hospitalization cost would be welcomed. The actual expenses of the

material cost should match with the budget plan so as to be cost effective. Also,

no adverse effect should be noted among the patients.

Nature and number of patients involved

The patients involved in the evaluation would be the same as the target

population.

For the sample size calculation, according to the table of evidence, the

average of the effect size is around 2.1cm of the VAS and the maximum stigma

is 2.82. With reference of the five selected studies, the level of significance

equals to 0.05 and the power equals to 0.8. By using the two-tailed paired t-test,

46

the number of patients needed should be 20. In addition, the average dropout

rate of the 5 selected studies is around 10%. Therefore, the sample size included

the dropout rate should be 23.

Data collection

Data collection process would be performed throughout the full scale

implementation.

Eligible cases once referred by the medical officers with their demographic

data would receive a leaflet about the innovation and an informed consent for

the participation in the innovation. The number of eligible patients and the

participation rate would be recorded in order to calculate the utilization rate of

the innovation.

In the full scale implementation, the menstrual pain chart would be

distributed to patients during the education session for the record of the pain

score, which is the primary outcome, before and after the innovation applied.

Evaluation questionnaire has been showed in Appendix IX about the satisfaction

level would be distributed to patients during the follow up sessions which is

every two months apart.

For the staff satisfaction level, evaluation questionnaire has been attached

as Appendix X would be distributed to them at the end of sixth, and twelve

47

month.

Data analysis

For data analysis, Statistical Package for Social Sciences version 20 would

be used. For the demographic data received during the referral, Chi-square test

would be used to analyze the baseline different among the participants. The

mean with the standard deviation of the VAS would be calculated. A two-tailed

paired t-test would be used to determine the effectiveness of the innovation in

pain reduction. The percentage of the response from the self reported Likert

Scale questionnaire would be calculated so as to find out the satisfaction level of

both patients and staff.

48

4.4 Basis for Implementation

A comprehensive outcome and process evaluation enhances the

effectiveness of the innovation. For patients, as mentioned in the sample size

calculation, it would be consider as effective if the VAS pain score lowered by 2.

For the level of satisfaction of patients and staff, it would be effective if more

than 70% of the patients and staff chose “Strongly Agree” or “Agree” on the

level of satisfaction. Besides, all the items should obtained a statistically

significant p-value <0.05. Moreover, the utilization of the innovation is also

important. The staff moral should be raised under the implementation of the

innovation. Last but not least, the innovation should be updates from time to

time according the results of evaluation and feedbacks.

49

Conclusion

Despite the usual first line treatment of primary dysmenorrhea which is the

use of pharmalogical therapy, the use of ginger powder capsule, an alternative

therapy, was evidence proved to be effective. With literature supported, an

evidence-based guideline had been generated. The innovation could benefit

patients with primary dysmenorrhea, reduce the medical expenditure included

material costs and manpower costs on the above diagnosis and promote the

economy of the society by a reduction of absenteeism from work or school.

50

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Chia, C.F., Lai, J.H.Y., Cheung, P.K., Kwong, L.T., Lau, F.P.M., Leung, K.H.,

Leung, M.T., Wong, F.C.H., & Ngu, S.F., (2013). Dysmenorrhoea among

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Daniels, S.E., Torri, S., & Desjardins, P.J., (2005). Valdecoxib for treatment of

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Dermarderosian, A., & Beutler, J.A., (2000). Review of natural products. St.

Louis: Facts and Comparisons, 243-6.

Doty, E., & Attaran, M., (2006). Managing primary dysmenorrhea. Journal of

Pediatric & Adolescent Gynecology, 19(5), 341-44.

Fraser, I.S., (1992). Prostaglandins, prostaglandin inhibitors and their roles in

gynaecological disorders. Baillieres Clin Obstet Gynaecol, 6, 829-57.

Gardiner, P., Whelan, J., White, L.F., Filippelli, A.C., Bharmal N., & Kaptchuk,

T.J., (2013). A systematic review of the prevalence of herb usage among

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Harel, Z., (2006). Dysmenorrhea in adolescents and young adults: etiology and

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Hospital Authority, (2014). Hospital Authority Statistical Report 2012-2013.

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Jenabi, E., (2013). The effect of ginger for relieving of primary dysmenorhoea. J

Pak Med Assoc, 63(1), 8-10.

Kashefi, F., Khajehei, M., Cher, M.T., Alavian, M., & Asili, J., (2014).

Comaprison of the effect of ginger and zinc sulfate on primary dysmenorrhea:

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Kashefi, F., Khajehei, M., Alavinia, M., Golmakani, E., & Asili, J., (2015).

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Appendix II

55

PRISMA 2009 Flow Diagram

From: Moher D, Liberati A, Tetzlaff J, Altman DG, 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

Records identified through

database searching (n = 26)

PubMed=16

CINAHL Plus=2

The Cochrane Library=8

Additional records identified

through other sources (n = 2)

(Manual searching from

reference of selected studies)

Records after duplicates removed (n = 16)

Full-text articles assessed for

eligibility (n = 12)

Records excluded (n = 2) Records screened (n = 14)

Studies included (n = 5) Included

Eligibility

Screening

Identification

Full-text articles excluded (n=7)

According to inclusion and

exclusion criteria and limited to

clinical trial studies:

Not primary dysmenorrhea only

(n=3)

Not clinical trial (n=4)

Appendix II

56

Bibliographic Citation of Selected Studies

Jenabi, E., (2013). The effect of ginger for relieving of primary dysmenorhoea. J

Pak Med Assoc, 63(1), 8-10.

Kashefi, F., Khajehei, M., Cher, M.T., Alavian, M., & Asili, J., (2014).

Comaprison of the effect of ginger and zinc sulfate on primary

dysmenorrhea: a placebo-controlled randomized trial. Pain Manag Nurs,

15(4), 826-833

Marjan, A.S., Narges, M.T., & Abbas, A. (2015). The effect of mefenamic acid

and ginger on pain relief in primary dysmenorrhea: a randomized clinical

trial. Arch Gynecol Obstet, 291, 1277-1281.

Rahnama, P., Montazeri, A., Huseini, H.F., Kianbakht, S., & Naseri, M., (2012).

Effect of Zingiber officinale R. rhizomes (ginger) on pain relief in primary

dysmenorrheal: a placebo randomized trial. BMC Complement & Altern

Med, 12(1), 92

Ozgoli, G., Goli, M., & Moattar, F., (2009). Comparison of effects of ginger,

mefenamic acid, ibuprofen on pain in women with primary dysmenorrhea.

J Altern Complement Med, 15(2), 129-132.

Table of Evidence Appendix III

57

Citation / Design

(Study quality)

Sample characteristics Intervention Control Outcomes (Assessment time) Effect size

(Intervention-Control)

Jenabi (2013)

RCT (1++)

70 single female

Primary dysmenorrhea

Pain: VAS>3/10cm

Age mean: GG=21.33+/-1.16

PG=21.54+/-1.78

Menarche age mean:

GG=13.36+/-1.71

PG=13.66+/-1.32

BMI mean: GG=21.33+/-1.30,

PG=22.78+/-1.55

GG:

500mg ginger

capsule TDS in the

1st 3 days of

menstrual period

(n=35)

PG:

Powdered placebo

capsule TDS in

the 1st 3 days of

menstrual period

(n=35)

Pain intensity:

VAS(0-10cm)

(0, 1st, 2

nd & 3

rd day of menstrual

period)

Post-treatment feeling:

5-point Likert scale (much worse

worsesamebettermuch better)

(after one menstruation)

Pain intensity:

3.33 (p=0.001)

Post-treatment

improvement:

35.8%

(p=0.001)

Kashefi et al.

(2014)

RCT (1++)

150 female (aged 15-18)

Primary dysmenorrhea

Regular menstrual cycles

Pain: VAS >4/10cm

Age mean: 17+/-4.3

Menarche age mean:

GG=12.8+/-1.14,

PG=12.4+/-1.2

GG:

250mg capsule TDS

for 4 days from the

day before to 3rd

day

of menstrual period

for 2 conservative

cycles

(1st month n=47, 2

nd

month n=45)

PG:

Lactose capsules

TDS for 4 days

from the day

before to the 3rd

day of menstrual

period for 2

conservative

cycles

(1st month n=45,

2nd

month n=42)

Pain intensity:

VAS(0-10cm)

(Every 24 hours during intervention

days)

Adverse effects

(Diarrhea, headache, heartburn)

(after every cycle)

Pain intensity:

After 1st month: 0.93

After 2nd

month: 3.87

(p<0.001)

Adverse effects:

1.9% (p=0.85)

BMI=body mass index; VAS=visual analog scale; GG=ginger group; PG=placebo group; TDS=3 times a day

Table of Evidence Appendix III

58

Citation / Design

(Study quality)

Sample characteristics Intervention Control Outcomes

(Assessment time)

Effect size

(Intervention-Control)

Marjan et al.

(2015)

RCT (1-)

122 adult female (unspecified marital

status)

Primary dysmenorrhea with regular cycle

Pain: VAS >4/10cm

Age mean: GG=21.60+/-2.14, MG=

21.62+/-2.0

Menarche age mean: GG=13.29+/-1.32,

MG=13.14+/-1.15

BMI mean (kg/m2): GG=21.65+/-3.08,

MG=21.84+/-3.92

GG:

250mg capsules Q6H

from onset of

menstrual period till

pain relief x2 cycles

(n=61)

MG (usual care):

250mg capsules Q8H

from onset of

menstrual period till

pain relief x2 cycles

(n=61)

Pain intensity:

VAS (0-10cm)

(0 & last day of

menstrual period of

every cycle)

Pain intensity

1st

month: 0.447

2nd

month: 0.444

(p>0.05)

Rahnama et al.

(2012)

RCT (1+)

105 single adult female

Primary dysmenorrhea

Regular menstrual cycle

Mean Pain: VAS 7.4cm

Age mean: GG=21.4+/-2.0,

PG=21.3+/-2.2

Menarche age mean: GG=13.7+/-0.9,

PG=13.6+/-1.1

BMI mean (kg/m2): GG=20.4+/-2.2,

PG=20.7+/-2.2)

GG:

500mg Ginger powder

capsule TDS

Protocol 1:

2 days before onset till

3rd

day of menstrual

period (n=59)

Protocol 2:

1st 3 day of menstrual

period only (n=59)

PG:

Toasted powder

placebo capsule TDS

Protocol 1:

2 days before onset till

3rd

day of menstrual

period (n=59)

Protocol 2:

1st 3 day of menstrual

period only (n=46)

Pain intensity:

VAS (0-10cm)

(before treatment &

after every cycle)

Adverse effect:

diarrhea, stomach

upset, heartburn

(before treatment &

after every cycle)

Pain intensity:

Protocol 1: 1.28

(p=0.015)

Protocol 2: 1.21

(p=0.029)

Adverse effect:

-3.6% (p>0.05)

BMI=body mass index; VAS=visual analog scale; GG=ginger group; MG=mefenamic acid group; PG=placebo group; Q6H=every six hour; Q8H=every eight

hour; TDS=3 times a day

Table of Evidence Appendix III

59

Citation / Design

(Study quality)

Sample characteristics Intervention Control Outcomes (Assessment time) Effect size

(Intervention-Control)

Ozgoli et al.

(2009)

Clinical trial /

comparative study

(2-)

150 adult female (unspecified

marital status)

Moderate to severe primary

dysmenorrhea

Regular Menstrual cycle

Age mean: GG=21.5+/-2.6,

MG=21.8+/-2.3,

IG=21.3+/-2.3

Menarche age mean:

GG=12.9+/-0.9,

MG=12.9+/-1.3, IG=13+/-1.5

BMI mean (kg/m2):

GG=22.2+/-2.3,

MG=22.2+/-2.2, IG=22.3+/-2.3

GG:

250mg ginger

rhizome powder

capsule QID for

3 days from

onset of

menstrual period

(n=50)

2 Usual Care:

MG—

250mg mefenamic acid

capsule QID for 3 days from

onset of menstrual period

(n=50)

IG—

400mg ibuprofen capsule

QID for 3 days from start of

menstrual period

(n=50)

Pain intensity:

Verbal multidimensional

scoring system=

A 4-point scale: painless,

mild, moderate, severe

A 5-point scale: considerably

relieved, relieved, unchanged,

worse, considerably worse

Satisfaction: satisfied, not

satisfied

(before treatment & after

cycle)

Pain intensity:

-4% (p>0.05)

Rate of satisfaction:

Compared to MG=2%

Compared to IG=-2%

(p>0.05)

BMI=body mass index; GG=ginger group; MG=mefenamic acid group; IG=ibuprofen group; QID=4 times a day

Appendix IV

60

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

Guideline topic: Key Question No: Reviewer:

Before completing this checklist, consider:

1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the

study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated

higher than 1+

2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):

SECTION 1: INTERNAL VALIDITY

In a well conducted RCT study… Does this study do it?

1.1 The study addresses an appropriate and clearly focused question.

Yes

Can’t say

No

1.2 The assignment of subjects to treatment groups is randomised. Yes

Can’t say

No

1.3 An adequate concealment method is used.

Yes

Can’t say

No

1.4 The design keeps subjects and investigators ‘blind’ about treatment allocation.

Yes

Can’t say

No

1.5 The treatment and control groups are similar at the start of the trial. Yes

Can’t say □

No

1.6 The only difference between groups is the treatment under investigation.

Yes

Can’t say

No

1.7 All relevant outcomes are measured in a standard, valid and reliable way.

Yes

Can’t say

No

1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?

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

Can’t say

No

Does not apply

1.10 Where the study is carried out at more than one site, results are

comparable for all sites.

Yes

Can’t say

No

Does not apply

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

Appendix IV

61

2.1 How well was the study done to minimise bias? Code as follows:

High quality (++)

Acceptable (+)

Low quality (-)

Unacceptable – reject 0

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?

2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above.

Appendix IV

62

SIGN grading system 1999 – 2012

Levels of evidence

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 reports, case series

4 Expert opinion

Grades of recommendations

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

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+

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++

Evidence level 3 or 4; or

Extrapolated evidence from studies rated as 2+

Good practice points

Recommended best practice based on the clinical experience of the guideline development group

Appendix IV

63

Quality Assessment Using SIGN Methodology Checklist for Controlled Trials

Section 1:

Internal Validity

Jenabi (2013) Kashefi et al.

(2014)

Marjan et al.

(2015)

Rahnama et al.

(2012)

Ozgoli et al. (2009)

Clearly Focused

Question

Yes Yes Yes Yes Yes

Randomization Yes

Random table

Yes

Random table

Can’t say

Randomization

mentioned but

not specified

Can’t say

Randomization

mentioned but

not specified

No

Allocation

Concealment

Yes

Concealed

with envelop

Yes

Coded

No No Yes

Coded

Blinding No

Subject

blinded only

No

Subject

blinded only

No

Subject

blinded only

Yes

Double

blinded

Yes

Double blinded

Comparable

Groups

Yes Yes Yes Yes Yes

Treatment is the

Only Difference

Yes Yes Yes Yes Yes

Valid and

Reliable

Outcome

Measures

Yes

Visual Analog

Scale & Likert

Scale

Yes

Visual Analog

Scale

Yes

Visual Analog

Scale

Yes

Visual Analog

Scale

No

Verbal

multi-dimensional

scoring system

Drop-Out Rate 2.8% from

placebo group

1.43% in total

8.7% in total No drop-out

rate was

reported

28% from

placebo group

12.4% in total

0

Intention to Treat

Analysis

No No Yes Yes Yes

Comparable

Results from All

Sites

Not applicable No Not applicable Not applicable Not applicable

Appendix IV

64

Quality Assessment Using SIGN Methodology Checklist for Controlled Trials

Section 2: Overall

Assessment

Jenabi

(2013)

Kashefi et

al. (2014)

Marjan et al. (2015) Rahnama et al.

(2012)

Ozgoli et al.

(2009)

Risk of Bias

Minimized

++ ++ - + -

Overall Effect due

to Intervention

Alone

Yes Yes Yes Yes Yes

Result Applicable

to Target Group

Yes Yes Yes Yes Yes

Notes Blinding to

researchers

didn’t

mentioned

Blinding to

researchers

didn’t

mentioned

Randomization

method didn’t

specified

Concealment and

blinding to

researchers didn’t

mentioned

Randomization

method didn’t

specified

Drop-out rate is

acceptable

Concealment

didn’t mentioned

Non randomized

may increase

bias

Level of Evidence 1+ 1+ 1- 1+ 1-

Appendix V

65

Cost-Benefit Ratio Calculation

Estimated set-up cost of the innovation

Item Estimated Cost Total (HK$)

Material cost Information leaflet HK$0.5/leaflet x 180clients 90

Assessment form HK$0.5/form x 180clients 90

Evaluation form HK$0.5/form x 180clients 90

Menstrual pain chart HK$0.5/chart x 180clients 90

Poster HK$1/poster x 5 5

Ginger HK$20/kg x 0.0015kg/day

x3day/cycle x 2cycle x

180clients

33

Empty capsule HK$0.01/capsule x

6capsule/day x 3day/cycle x

2cycle x 180clients

65

Drying machine HKS2500 2500

Grinding machine HKS2500 2500

Nonmaterial cost Pharmacist ─ ginger

processing and dispensing

HKS225/hour x 8hour/month x

12month

21600

Extra Nurse ─ holding the

innovation

HKS200/hour x 8hour/week x

52week

83200

Training cost Time cost for nurses to attend

training

HK$200/hour x 4hour x

20nurse

16000

Instructor ─ Chinese

Medicine practitioner

HKS250/hour x 2hour 500

Instructor ─Registered Nurse HKS200/hour x 2hour 400

Total set-up cost of

the innovation/year

127163

Appendix V

66

Estimated running cost of the innovation per year

Item Estimated Cost Total (HK$)

Material cost Information leaflet HK$0.5/leaflet x 180clients 90

Assessment form HK$0.5/form x 180clients 90

Evaluation form HK$0.5/form x 180clients 90

Menstrual pain chart HK$0.5/chart x 180clients 90

Poster HK$1/poster x 5 5

Ginger HK$20/kg x 0.0015kg/day

x3day/cycle x 2cycle x 180clients

33

Empty capsule HK$0.01/capsule x 6capsule/day

x 3day/cycle x 2cycle x 180clients

65

Nonmaterial cost Pharmacist ─ ginger

processing and dispensing

HKS225/hour x 8hour/month x

12month

21600

Nurse ─ holding the

innovation

HKS200/hour x 8hour/week x

52week

83200

Total running cost of

the innovation/year

105263

Estimated cost of not implementing the innovation

Item Cost Total (HK$)

Material cost mefenamic acid HK$0.1812/capsule x

6capsule/day x 3day x

180clients

588

lantacid HK$0.0885/tablet x

3tablet/day x 3day x

180clients

144

Nonmaterial cost Admission HK$4680/day x 2 days x

180clients

1684800

Total cost of

current practice

1685532

*Estimated 180 client/year

Mean salary of Registered Nurse in Hospital Authority ~HKS200/hour

Mean salary of Pharmacist in Hospital Authority ~HKS225/hour

Mean salary of Chinese Medicine Practitioner in Hospital Authority ~HK$250/hour

Mean hospitalization days for dysmenorrhea is 2 days

Total 20 Nursing staff in the target setting

Cost reduction = 1685532-127163/1685532x100 = 92.5%

Appendix VI

67

Evidence-Based Practice Guideline

Title

An evidence-based guideline of using ginger as pain relief method in primary

dysmenorrhea patients

Aim

To provide guidelines for nurses in helping patients with primary

dysmenorrhea to relieve pain by using ginger.

Objectives

To standardize the use of ginger as pain relief method in primary

dysmenorrhea patients

To guide nurses on the use of ginger in primary dysmenorrhea patients

To reduce pain intensity of primary dysmenorrhea patients

Major outcomes

To lessen pain level in patients with primary dysmenorrhea in order to

promote better quality of life and reduce admission rate and consultation

frequency

Target users

Nurses in gynecology ward who attended training about using ginger as pain

relief method

Target group

Patients who had admitted to gynecology ward or attended out-patient

consultation and diagnosed with primary dysmenorrhea together with the

followings:

- Menstrual pain level >3/10 in Visual Analog Scale

- Regular menstrual cycle

- BMI within 19-25 kg/m²

- No hormonal medication intake

- No pre-existing diagnosed disease

- No pregnancy history

Appendix VI

68

Recommendations

The recommendations are graded with the reference of the Scottish

Intercollegiate Guidelines Network (SIGN) (2015) (see Appendix IV)

Recommendation 1: Timing

Grade A ─ Taking ginger for the first three days of menstrual cycle (Jenabi,

2013) (1+); (Kashefi et al., 2014) (1+); (Marjan et al., 2015) (1-); (Rahnama et al.,

2012) (1+); and (Ozgoli et al., 2009) (1-)

Recommendation 2: Dosage & Frequency & Duration for Trial

Grade C ─ At least 250mg three times a day to maximum 500mg three times a

day which is 1500mg per day:

500mg three times a day=1500mg/day (Jenabi, 2013) (1+) and (Rahnama et

al., 2012) (1+)

250mg three times a day=750mg/day (Kashefi et al., 2014) (1+)

250mg four times a day=1000mg/day (Marjan et al., 2015) (1-) and (Ozgoli

et al., 2009) (1-)

Grade A ─ For 2 cycles (Kashefi et al., 2014) (1+); (Marjan et al., 2015) (1-);

and (Rahnama et al., 2012) (1+)

Recommendation 3: Ginger Capsule Preparation

Grade C ─ Preparation: fresh ginger chopped into pieces, baked for 24 hours,

ground into powder, filled in capsule after weighed (Jenabi, 2013) (1+)

Appendix VII

69

Menstrual Pain Chart

Please color the dates to indicate the days of menstrual period

Please mark the maximum pain score of the day in the box from 0-10

(rounding to 1 decimal place)

Year_____________ Month____________

Date 1 2 3 4 5 6 7 8 9 10

Pain

Date 11 12 13 14 15 16 17 18 19 20

Pain

Date 21 22 23 24 25 26 27 28 29 30 31

Pain

Year_____________ Month____________

Date 1 2 3 4 5 6 7 8 9 10

Pain

Date 11 12 13 14 15 16 17 18 19 20

Pain

Date 21 22 23 24 25 26 27 28 29 30 31

Pain

Year_____________ Month____________

Date 1 2 3 4 5 6 7 8 9 10

Pain

Date 11 12 13 14 15 16 17 18 19 20

Pain

Date 21 22 23 24 25 26 27 28 29 30 31

Pain

Notes:

Pain Score—Visual Analog Scale

0 1 2 3 4 5 6 7 8 9 10

No pain----------------------moderate------------------------Worse possible pain

Appendix VIII

70

Timeline for Implementation of the Innovation

Phase

Month

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

Forming communication working team

Obtaining approval

Communicating between stakeholders

Equipment preparation

Staff training and preparation

Pilot study

Pilot study evaluation and refinement

Full scale implementation

Innovation evaluation

Reporting

Appendix IX

71

Patient Satisfaction Questionnaire

Date: ______________________

Please the most appropriate box

Question Strongly

Agree

Agree Neutral Disagree

Strongly

Disagree

The instruction of the use of ginger

capsule is clear

The explanation provided by nurses is

adequate

The nurses are knowledgeable and

supportive

The intervention is helpful in pain

relieving

The menstrual chart is easy to use

The leaflet is informative

Overall, I satisfy with the intervention

Other feedback / comment / suggestion:

Thank you for your valuable comment!

Appendix X

72

Staff Satisfaction Questionnaire

Date: ______________________

Please the most appropriate box

Question

Strongly

Agree

Agree Neutral Disagree

Strongly

Disagree

The flow of the guideline is clear

I have enough knowledge about the

use of ginger in dysmenorrhea

I have confidence to educate patients

The workload of patient education

and follow up is affordable

The innovation is properly arranged

I have adequate support from the

communication working team

Overall, I satisfy with the guideline

Other feedback / comment / suggestion:

Thank you for your valuable comment!