chapter ii review of literature - shodhgangashodhganga.inflibnet.ac.in/bitstream/10603/50662/2/11....
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CHAPTER II
REVIEW OF LITERATURE
2.1 REVIEW OF LITERATURE
Review of literature refers to the activities involved in searching for information
on a topic and developing a comprehensive picture of the state as knowledge on that
topic ( Polit & Hungler, 1993).
Therefore the researcher studied and reviewed the related literature to broaden
the understanding about the topic to gain insight in to the selected problem
Section A: Literature regarding complementary therapies for hypertension
Section B: Literature regarding biofeedback on hypertension
Section C: Literature regarding anxiety among hypertensive patients
Section D: Literature regarding biofeedback on anxiety
Section A: Literature regarding complementary and alternative therapies for
hypertension
Hänsel & Känel (2012) presented a narrative review focusing on the current
stress concept and factors that influence the degree of blood pressure change following
a psychosocial stressor. Relevant psychosocial factors such as marital status, social
support, socioeconomic status, work conditions, personality and cognition on blood
pressure were discussed. It also focused on the outcome of cognitive-behavioural
therapies and relaxation techniques as a means to effectively control blood pressure.
They concluded that psychosocial factors and stressors may increase blood pressure
and agreed that with respect to therapeutic options, cognitive-behavioural interventions,
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combined with relaxation techniques all fitting the needs of the individual patient best
can offer a clinically meaningful contribution of an effective blood pressure control.
Anderson and Taylor (2012) compared complementary and alternative
medicine (CAM) use among those individuals in the United States who have known
coronary heart disease; n = 1055, general population among individuals who are not
having CVD or CVD risk factors, n = 22 290, as well as individuals with CVD risk
factors (hypertension, n = 6849 or high cholesterol, n = 5808) through secondary
analyses of the 2007 National Health Interview Survey data. Use of complementary
practices and products by patients with CVD and CVD risk factors was common and
significantly greater than individuals without CVD in the general population. The most
common categories of complementary modalities used by individuals with a self-
reported diagnosis of CVD or CVD risk factors were natural products and mind-body
practices.
Agte , Jahagirdar and Tarwadi (2011) undertook an open label intervention
study on 26 mild hypertensives and 26 apparently healthy adults of age group 30-60
yrs, for the effect of Sudarshan Kriya Yoga practice for two months as complementary
therapy. In the hypertensives, there was a significant decrease in diastolic blood
pressure (P < 0.01), serum urea (P < 0.01) and plasma MDA (malondialdehyde
adducts) as oxidative stress marker (P < 0.05). The pattern of change in most of the
study parameters was such that values above normal range were lowered but values
within normal range were unaltered.
Edwards , Wilson , SadjaJ, Ziegler and Mills (2011) investigated the effects
of lifestyle interventions on autonomic nervous system function in patients with
elevated BP. Sedentary participants with elevated BP were randomly assigned to either
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an exercise only (N = 25), exercise plus dietary approaches to stop hypertension
(DASH) diet (N = 12), or waitlist control (N = 15) 12-week intervention. Plasma nor
adrenaline was measured at rest and participants performed a peak exercise test before
and after the intervention. Heart rate recovery (HRR) was calculated as peak heart rate
(HR) minus HR at 1 min post-exercise. Similarly, exercise plus diet and exercise
groups, but not waitlist, showed significant increase in HRR, significant reductions in
BP from pre- to post-intervention. Linear regression revealed that BP post-intervention
was significantly predicted by change in HRR when controlling for pre-BP, age, gender
and BMI. Lifestyle interventions induced BP reduction and altered autonomic tone,
indexed by HRR. This study indicates the importance of behavioural modification in
hypertension and that increased parasympathetic function is associated with success in
reduction of BP.
Ireland, MacKenzie, Gould, Dassinger, Koper and LeBlanc (2010)
addressed the need to improve risk factor outcomes through identifying clients with
uncontrolled hypertension. Cognitive, self-efficacy and/or adherence characteristics
predictive of non-achievement of blood pressure targets and an expanded nurse case
management care delivery model was pilot tested for feasibility in a participant sample
of 20 clients. Motivational interviewing and self-management approaches were
combined with interventions designed to improve adherence: facilitation of the
simplification of medication routines, providing memory cues, home self-monitoring
equipment, counselling, and six-month nursing follow-up. At six months, there were
significant reductions in blood pressure and increases in medication self-efficacy and
adherence for selected clients identified with high risk for stroke and non-achievement
of treatment outcomes.
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Tang, Harms and Vezeau ( 2008) conducted a pilot study with purpose to
evaluate the effectiveness of an audio relaxation tool for lowering blood pressure and
augmenting heart rate variability (HRV) in older adults. Fourteen older adults (83 +/- 8
years) participated in the study. The intervention consisted of 12 sessions of a guided
relaxation program. Blood pressure was taken before and after each intervention. HRV
was assessed once before training and at the conclusion of the final session. Paired
sample t tests were used for data analysis. Comparing pre and post parameters for all
sessions, the intervention resulted in a statistically significant reduction in systolic
blood pressure (P < .001), diastolic blood pressure (P < .001), and heart rate (P < .005).
HRV was unaffected. This study provides support for the use of guided relaxation to
reduce high blood pressure in older adults.
Nahas (2008) reviewed the evidence supporting complementary and alternative
medicine approaches used in the treatment of hypertension. MEDLINE and EMBASE
were searched from January 1966 to May 2008 combining the key words hypertension
or blood pressure with acupuncture, chocolate, cocoa, coenzyme Q10, ubiquinone,
melatonin, vitamin D, meditation, and stress reduction. Clinical trials, prospective
studies, and relevant references were included. Evidence from systematic reviews
supports the blood pressure-lowering effects of coenzyme Q10, polyphenol-rich dark
chocolate, Qigong, slow breathing, and transcendental meditation. Vitamin D
deficiency is associated with hypertension and cardiovascular risk; supplementation
lowered blood pressure in 2 trials. Acupuncture reduced blood pressure in 3 trials;
melatonin was effective in 2 small trials. Investigators suggested that several
complementary and alternative medicine therapies can be considered as part of an
evidence-based approach to the treatment of hypertension.
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Dickinson et al. (2008) evaluated the effects of relaxation therapies on
cardiovascular outcomes and blood pressure in people with elevated blood pressure.
Meta-analysis of 25 RCTs, with eight weeks to five years follow-up, indicated that
relaxation resulted in small, statistically significant reductions in SBP (mean difference:
-5.5 mmHg, 95% CI: -8.2 to -2.8, I2 =72%) and DBP (mean difference: -3.5 mmHg,
95% CI: -5.3 to -1.6, I2 =75%) compared to control. The nine trials that reported
blinding of outcome assessors found a non-significant net reduction in blood pressure
(SBP mean difference: -3.2 mmHg, 95% CI: -7.7 to 1.4, I(2) =69%) associated with
relaxation. The 15 trials comparing relaxation with sham therapy likewise found a non-
significant reduction in blood pressure (SBP mean difference: -3.5 mmHg, 95% CI: -
7.1 to 0.2, I(2) =63%).
Linden and Moseley (2006) reviewed evidence for the efficacy of behavioral
treatments for hypertension. Extensive evidence from over 100 randomized controlled
trials indicated that behavioural treatments reduced blood pressure (BP) to a modest
degree, and this change was greater than what is seen in wait-list or other inactive
controls. Effect sizes were quite variable. The observed BP reductions were much
greater when BP levels were high at pre-test, and behavioural studies tend to
underestimate possible benefits because of floor effects in their protocols. Multi-
component, individualized psychological treatments lead to greater BP changes than do
single-component treatments. Among biofeedback treatments, thermal feedback and
electrodermal activity feedback fared better than EMG or direct BP feedback, which
tended to produce null effects.
Yeh, Davis and Phillips (2006) conducted a study using the 2002 National
Health Interview Survey and analyzed data on CAM use in 10,572 respondents with
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cardiovascular disease. Among those with CVD, 36% had used CAM in the previous
12 months. The most commonly used therapies were herbal products (18%) and mind-
body therapies (17%). Among mind-body therapies, deep-breathing exercises and
meditation were most commonly used. Overall, CAM was used most frequently for
musculoskeletal complaints. Mind-body therapies were also used for anxiety or
depression (23%) and stress or emotional health and wellness (16%). Fewer
respondents (10%) used CAM specifically for their cardiovascular conditions (5% for
hypertension, 2% for coronary disease, 3% for vascular insufficiency, < 1% for heart
failure or stroke) however most of them perceived the therapies to be helpful (80% for
herbs, 94% for mind-body therapies). CAM use was more common in younger
respondents, women, Asians, and those with more education and greater incomes. In
was concluded that, CAM use, particularly herbs and mind-body therapies, is common
in the United States in patients with cardiovascular disease and mirrors use in the
general population.
Tibbits, Ellis, Piramelli, Luskin and Lukman (2006) conducted a study with
objective to determine if patients with diagnosed stage-1 hypertension could benefit by
a forgiveness training program to achieve measurable reductions in anger expression
and blood pressure. Twenty-five participants were randomly divided into wait-listed
control and intervention groups. The control group monitored blood pressure while the
intervention group participated in an 8-week forgiveness training program. At the end
of eight weeks, the wait listed group became an intervention group. Those who
received forgiveness training achieved significant reductions in anger expression when
compared to the control group. While reductions in blood pressure were not achieved
by all the participants, those participants who entered the program with elevated anger
expression scores did achieve significant reductions in blood pressure.
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Ernst (2005) summarised the evidence from clinical trials of numerous herbal
remedies in which non-herbal remedies and other approaches have been tested and
some seemed to have antihypertensive effects. They felt that the effect size was usually
modest, and independent replications were frequently missing. According to them, the
most encouraging data pertain to garlic, autogenic training, biofeedback and yoga.
Section B: Literature regarding biofeedback on hypertension
McGrady (2010) described that the metabolic syndrome was likely to develop
in patients in whom genetic predisposition, chronic stress, negative emotion, and
unhealthy lifestyle habits converge. In light of the psycho-physiologic aspect of most of
these factors, biofeedback, relaxation, and other psycho-physiologic interventions have
been studied and used in patients with elements of the metabolic syndrome, particularly
diabetes and hypertension. The article reviewed the rationale and evidence for
biofeedback for the treatment of diabetes and hypertension, which has been shown to
effectively lower blood glucose and blood pressure in numerous studies. Investigator
felt that patients with pre-hypertension are particularly appropriate target population
for biofeedback for blood pressure reduction.
Tsai, Chang, Chang, Lee and Wang (2007) examined whether a 4-week
blood pressure (BP) biofeedback program can reduce BP and BP reactivity to stress in
participants with mild hypertension in a randomized controlled study. Participants in
the active biofeedback group (n=20) were trained in 4 weekly laboratory sessions to
self-regulate their BP with continuous BP feedback signals, whereas participants in the
sham biofeedback group (n=18) were told to manipulate their BP without feedback
signals. BP, skin temperature, skin conductance, BP reactivity to stress, body weight,
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and state anxiety were assessed before training and repeated at the eighth week after the
training. The decreases in systolic (12.6 +/- 8.8 versus 4.1 +/- 5.7) and mean BP (8.2
+/- 6.9 versus 3.3 +/- 4.9) from baseline at week 12 follow-up were significantly greater
in the active biofeedback group compared with the sham biofeedback group (p=0.001
and 0.017, respectively). The pre-to-post differences in skin conductance and SBP
reactivity were statistically significant for the biofeedback group (p=0.005 and 0.01,
respectively), but not for the control group. They concluded that BP biofeedback
exerted a specific treatment effect in reducing BP in individuals with mild
hypertension, possibly through reducing pressor reactivity to stress.
Khanna, Paul and Sandhu (2007) evaluated the effect of progressive muscle
relaxation training and galvanic skin response biofeedback training in reducing the
blood pressure and respiratory rate of stressed female students of age group 18–27 yrs.
Their stress level was assessed using Comprehensive Anxiety Test questionnaire. It
was administered to about 120 females undergraduate, post graduate, graduate and
research scholars from Guru Nanak Dev University, Amritsar, India. 30 highly stressed
females with high anxiety scores, who were free from any ailments and not undergoing
any kind of medication treatment were chosen for the study. Of these subjects, 20 were
randomly fedback from the machine. Blood pressure was measured using
sphygmomanometer with conventional method and respiratory rate was recorded by
observing the movement of chest wall for one minute. There were two training groups:
GSR biofeedback training (n = 10) and PMR training (n = 10). The remaining 10
subjects were taken as control. The training was provided for 20 min daily for 10
consecutive days. Results indicated that PMR group showed significant differences for
SBP (P<0.05) and DBP (P<0.001). Pre and post session comparison of blood pressure
values of GSR biofeedback group on day 1 revealed significant reduction in SBP
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values (P<0.05) while no effect was observed for DBP while on day 10, both SBP and
DBP values showed significant differences in pre and post session values. Results
indicated the effectiveness of GSR biofeedback training in reducing blood pressure
after training session. PMR group showed significant reduction in pre-post session
values of SBP and DBP on day 10 only. Control group (group 3) did not show
significant results on both day 1 and day 10 .
Toshiho, Kazuhiro, Fusae and Haruna (2006) demonstrated the efficacy of
biofeedback (BF) therapy using electroencephalograms (indirect method) and BF
therapy using a monitoring system in the treatment of hypertension and white-coat
hypertension, and reported that a combination of BF therapy (indirect method) and
relaxation therapy was also effective. In the present study, they compared the effects
of a combination of the direct method and relaxation therapy (11 cases) for essential
hypertension with those of the direct method alone (20 cases). After BF therapy,
systolic blood pressure, diastolic blood pressure, anxiety score, and depression score
decreased significantly in both groups. Comparing the two groups, significantly higher
effects on systolic blood pressure, diastolic blood pressure, anxiety score, and
depression score were obtained in the combination therapy group than in the mono-
therapy group.
McGrady, Nadsady and Schumann-Brzezinski (2005) assessed the usefulness
of biofeedback-assisted relaxation as an adjunct or substitute for pharmacotherapy in
essential hypertension and whether can be enhanced if the effects are shown to persist
after formal treatment has ended. Patients with essential hypertension successfully
treated with biofeedback-assisted relaxation were recalled for follow-up yearly after the
termination of treatment. Twenty-six of 40 patients met the BP criterion for success. At
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one-, two-, and three-year follow-up, 31%, 38%, and 27% of the successful completers
continued to meet the criterion for success. The pretreatment-posttreatment decreases in
BP were accompanied by decreases in forehead muscle tension and urinary cortisol.
Forehead muscle tension, urinary cortisol, and anxiety levels were significantly lower
than pretreatment one year after the end of treatment. Self-report data were used to
assess continued relaxation practice. It was concluded that some patients trained in
biofeedback-assisted relaxation can maintain lowered blood pressure, muscle tension,
anxiety, and cortisol levels over the long term.
Carolyn et al. (2005) conducted a study was to determine the effectiveness of
biofeedback in the treatment of stages 1 and 2 essential hypertension via meta-
analytical methods. A utilization-focused integrative review was limited to adult
randomized clinical trials, and study groups were categorized into biofeedback, active
control, and inactive control. Both biofeedback and active control treatments resulted in
a reduction in systolic blood pressure (SBP) and diastolic blood pressure (DBP). Only
biofeedback (with related cognitive therapy and relaxation training) showed a
significantly greater reduction in both SBP (6.7 mm Hg) and DBP (4.8 mm Hg) when
compared with inactive control treatments. The investigator also suggested that nurses
in practice settings should consider biofeedback therapy for their hypertensive clients.
Yucha et al. (2005) conducted a study to develop a way to predict which
persons with essential hypertension would benefit most from biofeedback-assisted
relaxation (BFAR) training. The authors evaluated the effect of BFAR on blood
pressure (BP) reduction, which was measured in the clinic and outside the clinic using
an ambulatory BP monitor. Fifty-four adults with stage 1 or 2 hypertension (78%
taking BP medications) received 8 weeks of relaxation training coupled with thermal,
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electromyographic, and respiratory sinus arrhythmia biofeedback. Blood pressure was
measured in the clinic and over 24 hours using an ambulatory BP monitor pretraining
and posttraining. Systolic BP dropped from 135.0 ± 9.8 mm Hg pretraining to 132.2 ±
10.5 mm Hg posttraining (F = 6.139, P = .017). Diastolic BP dropped from 80.4 ± 8.1
mm Hg pretraining to 78.5 ± 10.0 mm Hg posttraining (F = 4.441, P = .041). Data from
37 participants with baseline BP of 130/85 mm Hg or greater were used to develop a
prediction model. Regression showed that those who were able to lower their SBP 5
mm Hg or more were (1) not taking antihypertensive medication, (2) had lowest
starting finger temperature, (3) had the smallest standard deviation in daytime mean
arterial pressure, and (4) the lowest score on the Multidimensional Health Locus of
Control-internal scale. Author suggested that since these types of persons are most
likely to benefit from BFAR, they should be offered BFAR prior to starting
hypertensive medications
Del Pozo et al. (2004) tried to determine if cardio respiratory biofeedback
increases heart rate variability (HRV) in patients with documented coronary artery
disease (CAD). Patients with established CAD (n = 63; mean age, 67 years) were
randomly assigned to conventional therapy or to 6 biofeedback sessions consisting of
abdominal breath training, heart and respiratory physiologic feedback, and daily
breathing practice. HRV was measured by the standard deviation of normal-to-normal
QRS complexes (SDNN) at week 1 (pretreatment), week 6 (after treatment), and week
18 (follow-up). The SDNN for the biofeedback and control groups did not differ at
baseline or at week 6 but were significantly different at week 18. The biofeedback
group showed a significant increase in SDNN from baseline to week 6 (P < .001) and to
week 18 (P = .003). The control subjects had no change from baseline to week 6 (P =
.214) and week 18 (P = .27).
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Nakao, Yano, Nomura and Kuboki (2003) tried to examine the blood
pressure-lowering effects of biofeedback treatment in patients with essential
hypertension, a meta-analysis was conducted on studies published between 1966 and
2001. A total of 22 randomized controlled studies with 905 essential hypertensive
patients were selected for review. Compared with clinical visits or self-monitoring of
blood pressure (non-intervention controls), biofeedback intervention resulted in systolic
and diastolic blood pressure reductions that were greater by 7.3 mmHg (for systole;
95% confidence interval: 2.6 to 12.0) and 5.8 mmHg (for diastole; 95% confidence
interval: 2.9 to 8.6). Compared with sham or non-specific behavioural intervention
controls, the net reductions in systolic and diastolic blood pressures by biofeedback
intervention were 3.9 (95% confidence interval: -0.3 to 8.2) and 3.5 (-0.1 to 7.0)
mmHg, respectively. The results of multiple regression analysis also indicated that
biofeedback intervention decreased systolic and diastolic blood pressures more than
non-intervention controls (p < 0.001), but not more than sham or non-specific
behavioural intervention controls (p > 0.05), when controlling for the effects of initial
blood pressures. When biofeedback intervention types were classified into two types,
simple biofeedback and relaxation-assisted biofeedback, only the relaxation-assisted
biofeedback significantly decreased both systolic and diastolic blood pressures (p <
0.05) compared with those in sham or non-specific behavioral intervention controls.
Rau, Bührer and Weitkunat (2003) investigated whether biofeedback of
the R-wave-to-pulse interval, a measure related to the pulse wave velocity, enabled
participants with either high or low arterial blood pressure to modify their blood
pressure. Twelve participants with high blood pressure (mean systolic blood pressure =
142.6 +/- 13.5 mmHg; mean diastolic blood pressure = 99.9 +/- 12.3 mmHg) and 10
participants with low blood pressure (mean systolic blood pressure = 104.8 +/- 6.6
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mmHg; mean diastolic blood pressure = 73.2 +/- 4.2 mmHg) received 3 individual
sessions of RPI biofeedback within a 2-week period. Participants with high blood
pressure were rewarded for decreasing and participants with low blood pressure for
increasing their blood pressure. Standard arm-cuff blood pressure measurements across
the sessions served as dependent variables. Participants with high blood pressure
achieved significant reductions of systolic (15.3 mmHg) and diastolic (17.8 mmHg)
blood pressure levels from the beginning of the first to the end of the last training
session. In contrast, participants with low blood pressure achieved significant increases
in systolic (12.3 mmHg) and diastolic (8.4 mmHg) blood pressure levels.
Linda and Paul (2003) studied a variety of non pharmacologic interventions
in an attempt to discover their use as therapies for these diseases. The literature relating
to the use of biofeedback therapies for hypertension, cardiac arrhythmias, angina
pectoris, cardiac ischemia, myocardial infarction, and Raynaud's phenomenon was
reviewed. They identified that various methods of biofeedback have shown promise in
the treatment or management of several cardiovascular disorders. The number and
types of studies in each of these areas varied widely, but biofeedback was suggested to
be a useful alternative or adjunct to more conventional forms of treatment.
Nakao, Nomura, Shimosawa, Fujita and Kuboki (2000) compared blood
pressure (BP) biofeedback treatment (BF) effects between white-coat hypertension and
essential hypertension. Fifteen white-coat hypertensive out-patients and 23 essential
hypertensive out-patients were randomly assigned to groups A or B. Subjects in group
A underwent BF once a week for a total of four sessions. Those in group B visited the
clinic only to measure BP and later underwent the same BF. In group A, BPs of white-
coat hypertensives and essential hypertensives were significantly reduced by 22/11 and
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14/8 mmHg, respectively. In group B, they were unchanged during the same period but
later suppressed by BF. Under BF, elevation of diastolic BP due to mental stress testing
was better suppressed in white-coat hypertensives than in essential hypertensives. This
treatment was effective in both types of hypertension, and pressor response to stress
seems to be important in the differentiated BF effect.
Libo and Arnold (1983) did a follow-up study 1 to 5 years after biofeedback
therapy, involving 58 patients in six diagnostic groups (migraine headache, tension
headache, mixed headache, chronic pain, anxiety, and essential hypertension), revealed
that 86% of the patients who continued to practice relaxation techniques improved,
while only 50% of those who had stopped practice improved (p=.04). Among the
patients who improved, 91% had continued to practice and only 9% had stopped
practice, while among the patients who did not improve, 63% had continued to practice
and 36% had stopped practice. Patients who were practicing only occasionally, as
needed, or when stressed improved as much as or more than those who practiced
regularly and frequently (i.e., at least weekly): 89% versus 77% improved, respectively
(p=n.s). There was no difference in the occurrence or frequency of relaxation practice
between patients who have been out of therapy 3 to 5 years and those who completed
therapy more recently, or between those who were in brief versus longer-term therapy.
Although continued relaxation practice is significantly related to the maintenance of
long-term improvement, a few patients manage to improve without it, or continue to
practice yet relapse. It also appeared that only occasional relaxation practice after
therapy is sufficient to maintain long-term therapeutic gains.
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Section C: Literature regarding anxiety among hypertensive patients
Aydoğan et al. (2012) examined the frequency of anxiety disorders among
hypertensive patients. 52 primary hypertensive patients followed by Gulhane Military
Medical Akademi (GATA) Internal Medicine Polyclinic were included. Beck Anxiety
Inventory (BAI) was applied and blood pressures were measured in polyclinic
(measured by physician in sitting position) and house measures were recorded. Co-
morbid diseases and drugs used by patients were asked, all data were transferred to
database. 63.46% (n=33) of patients were female and 36.54% (n=19) male. Mean age
was 57.33±15.88 (20-91). The mean systolic blood pressure was detected 137.50±18.79
(110-180) mmHg, while diastolic blood pressure was 79.38±7.71 (60-90) mmHg in
polyclinics. When BAI scores were examined, the average score was found as 14.61 ±
8.80 (3-36) and 25% (n=13) of patients had minimal anxiety, 36.5% (n=19) mild, 25%
(n=13) moderate and 13.5% (n=7) severe anxiety. There wasn’t a statistically
significant difference between BAI scores and blood pressure values at target (p>0.05).
Bajkó et al. (2012) examined the relationship between autonomic nervous
system dysfunction, anxiety and depression in untreated hypertension. 86 newly
diagnosed hypertensive patients and 98 healthy volunteers were included in the study.
The psychological parameters were assessed with Spielberger State-Trait Anxiety
Inventory and Beck Depression Inventory by a skilled psychologist. Autonomic
parameters were examined during tilt table examination (10min lying position, 10min
passive tilt). Heart rate variability (HRV) was calculated by autoregressive methods.
Baroreflex sensitivity (BRS) was calculated by non-invasive sequence method from the
recorded beat to beat blood pressure values and RR intervals. Significantly higher state
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(42.6±9.3 vs. 39.6±10.7 p=0.05) and trait (40.1±8.9 vs. 35.1±8.6, p<0.0001) anxiety
scores were found in the hypertension group. There was no statistically significant
difference in the depression level. LF-RRI (Low Frequency-RR interval) of HRV in
passive tilt (377.3±430.6 vs. 494.1±547, p=0.049) and mean BRS slope (11.4±5.5 vs.
13.2±6.4, p=0.07) in lying position were lower in hypertensives. Trait anxiety score
correlates significantly with sympatho/vagal balance (LF/HF-RRI) in passive tilt
position (Spearman R=-0.286, p=0.01).
Rafanelli, Offidani, Gostoli and Roncuzzi (2012) aimed to assess clinical
and subclinical distress, psychosocial aspects and psychological well-being in treated
hypertensive patients and to evaluate the psychosocial variables associated with higher
levels of blood pressure according to guidelines for hypertension management. A
consecutive series of 125 hypertensive patients were evaluated using both self- and
observer-rated reliable measures. Generalized anxiety disorder, minor depression,
demoralization and alexithymia were the most frequent diagnoses. Cluster analysis
revealed an association of three distinct symptomatological groups such as the Anxiety-
Depression, the Alexithymia and the Somatization groups, with different levels of
hypertension. Patients with moderate to severe hypertension were more frequently in
the Anxiety-Depression and the Alexithymia groups, whereas the Somatization cluster
has been shown to be associated with isolated systolic hypertension.
Chiaie et al. (2011) investigated the nature of the association between
hypertension and subsyndromal depression in hospitalized hypertensive patients.196
hypertensive and 96 non hypertensive inpatients underwent a SCID interview, to
exclude patients positive for any Axis I or Axis II diagnosis. Symptomatic
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Subsyndromal Depression (SSD) was identified according to criteria proposed by Judd.
Psychopathological assessment was performed with Anxiety Sensitivity Index (ASI)
and Hopkins Symptom Checklist-90 (SCL-90). Clinical assessments included blood
pressure measurement, evaluation of general health conditions and screening
cardiovascular risk factors (smoke, alcohol, body weight, sedentary life style).
Hypertensives met more frequently criteria for SSD. They also scored higher on ASI
and SCL-90.
Saboya, Zimmermann and Bodanese (2010) aimed to test the hypothesis
that arterial hypertension can be associated with anxiety and depressive symptoms and
to verify its effect on the quality of life. A controlled cross-sectional study included 302
patients (152 hypertensive and 150 normotensive) outpatients at a selected hospital.
Measurements were made in individual interviews and included data collection and
application of general scales such as State-Trait Anxiety Inventory (STAI), Beck
Depression Inventory (BDI), and Medical Outcome Study Short Form, General Health
Survey (SF-36).Anxiety was significantly associated with SAH only after adjusted for
relevant risk factors (odds ratio (OR) = 2.83, 95% confidence interval (CI) = 1.55 to
5.18). Depressive symptoms were significantly associated with SAH (OR) = 4.34 (95%
CI: 2.34 to 8.06). A significant association between quality of life and SAH were also
found and the effect of depressive symptoms, in particular, and anxiety, in the
worsening of quality of life.
Hamer, Batty, Stamatakis and Kivimaki (2010) in a representative study of
33 105 adults (aged 51.7+/-12.1 years; 45.8% men), measured levels of psychological
distress using the 12-item General Health Questionnaire and collected blood pressure,
data on history of hypertension diagnosis, and medication usage. Awareness of
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hypertension was confirmed through a physician diagnosis or the use of
antihypertensive medication, and unaware hypertension was defined by elevated clinic
blood pressure (systolic/diastolic > or =140/90 mm Hg) without previous treatment or
diagnosis. In comparison with normotensive participants, an elevated risk of distress
(General Health Questionnaire score > or =4) was observed in aware hypertensive
participants (multivariable adjusted odds ratio: 1.57 [95% CI: 1.41 to 1.74]) but not in
unaware hypertensives (odds ratio: 0.91 [95% CI: 0.78 to 1.07]). Antihypertensive
medication and comorbidity were also associated with psychological distress. These
findings suggest that distressed participants were more likely to have low or highly
elevated blood pressure and labeling individuals as hypertensive, rather than having
elevated blood pressure, may partially explain the greater levels of distress in patients
treated for hypertension.
Masmoudi et al. (2010) focussed on the links between the blood pressure
imbalance and some psychosocial factors in a population of ambulatory patients with
hypertension. It was a cross-sectional study on 100 patients with hypertension followed
up in Cardiology in Sfax (Tunisia). Anxiety and depression were assessed by the
Hospital Anxiety and Depression Scale (HADS). Behavioural pattern was evaluated by
a clinical interview, referring to the model of Friedman and Rosenman. They also
collected socio-environmental, clinical, therapeutic and prognostic data. The most
predictive factors of an unbalanced blood pressure were independently: personality
type "A" or unspecified (p = 0002), high fat diet (p = 0026), poor drug adherence (p =
0038) and depression (p = 0015).Several sociodemographic and lifestyle factors are
interrelated and implicated in the blood pressure imbalance, suggesting the need of a
hygienic behavior joining the international recommendations.
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Joyner, Mount, McCorkle, Simmons, Ferrario and Cline (2009) in response
to almost universally recorded poor blood pressure (BP) control rates, developed a
novel health paradigm model to examine the mindset behind BP control barriers. This
approach, termed patient inertia (PtInert), is defined as an individual's failure to take
responsibility for health conditions and proactive change. Fifty percent of patients
reported slight psychological distress (psychosomatic > anxiety > depression), with
61% possessing hopelessness surrounding complications from high BP no matter their
actions. An unanticipated finding was that patients who had a low reading proficiency
self-reported high levels of hypertension health literacy. Less than half of patients
transferred this health literacy into lifestyle changes in diet, exercise, and medication
adherence. Although patients felt that they could control their BP and frequently
thought about better BP control, 55% of the subjects had uncontrolled hypertension
(>140/90 mm Hg).
Antropova, Osipova, Simonova , Vorob'eva , Pyrikova and Zal'tsman
(2009) elucidated rates of development of arterial hypertension (AH) at working place
(wp), risk factors of cardiovascular diseases (CVD) and anxiety depressive disorders in
persons with professional stress using the Hamilton scale in 138 men (mean age 40.0+/-
1.2 years). Results of the study evidenced for high frequency (46.4%) of development
of AHwp among representatives of stressful occupations. Patients with AHwp have risk
factors of CVD development and total coronary risk comparable with those of patients
with hypertensive disease. Patients with AH have more pronounced anxiety depressive
disorders than healthy subjects.
Han, Yin, Xu, Hong , Liang and Wang (2008) studied the current situation of
depression and anxiety from patients with hypertension as well as to provide reference
35
for the development of control and prevention program. Participants older than 35-year
including both hypertensive patients and healthy controls were randomly selected in 2
communities through Health Behavior Survey. All the subjects were assessed by the
Zung's self-rating depression scale (SDS) and the Zung's self-rating anxiety scale
(SAS).Raw score and index score of SDS and SAS were both significantly (P < 0.01)
greater in hypertensive patients than in healthy control group. The prevalence of
depression of 17.9% and anxiety of 9.5% in patient group were found significantly
higher than that in healthy control group as 11.5% and 4.3%. Data from logistic
regression model analysis showed that depression and anxiety were possible risk
factors of hypertension (OR = 1.677, 95% CI: 1.013-2.776; OR = 2.451, 95% CI:
1.228-4.894). There was a combined effect seen between depression and anxiety (OR =
5.238, 95% CI: 2.356-11.664).
Wei and Wang (2006) investigated incidence and severity of anxiety
symptoms in patients with hypertension. A cross-sectional survey in 891 (432 females)
hypertensive patients was conducted in a regional community. All patients were
interviewed and detailed physical examination was performed. Zung self-rating anxiety
scale (SAS) was used to evaluate the severity of anxiety symptoms. Anxiety was
diagnosed on clinical grounds in 103 patients (11.6%) who also had a raw SAS score of
more than 40. In all subjects surveyed, the average SAS score in females was higher
than males (32.9+/- 7.1 vs 31.2+/-6.4, p < 0.001). The average SAS score was also
higher in patients with hypertension of more than 3 years (32.4+/-7.0 vs 31.2+/-6.1, p =
0.01), in patients with severe hypertension (39.8+/-6.9 vs 29.6 4+/-4.5, p < 0.001), and
in patients with a history of hospitalization for cardiovascular disorders (35.7+/-7.7 vs
31.7+/-6.6, p < 0.001). Multivariate regression analysis showed that female gender,
36
duration of hypertension, and hospitalization history were independent predictors of
anxiety symptoms (p < 0.05).Almost 12% of hypertensive patients have anxiety
symptoms.
Cilli et al. (2007) verified whether hypertensive patients, with recent or old
poor-controlled hypertension, asymptomatic for anxiety and/or depression, seemed
more disturbed in personality than normotensive patients.122 patients with arterial
hypertension and 65 normotensive subjects (37 women, 28 men, middle age 41 +/-
11.7 years) answered two self-extiming questionnaires: A.S.Q. by Krug and Cattel and
C.D.Q. by Krug and Laughlin. 37 hypertensive patients (30.3%) were positive in the
C.D.Q. and 34 (27.8%) in the A.S.Q. test. In the group of normotensive subjects, 13
(20%) were positive in C.D.Q. and 12 (8.4%) in A.S.Q. There was a statistical
difference in C.D.Q and A.S.Q. between hypertensive and normotensive subjects. No
statistical difference was found in C.D.Q. and A.S.Q. between new and old-
hypertensives. The study has shown a significant higher level of anxiety and depression
in hypertensive subjects as compared to normotensives. However, no significant
difference in anxiety and depression levels was found between new- and old-
hypertensive patients or in relation with the use of antihypertensive drugs.
Vetere, Ripaldi, Ais , Korob , Kes and Villamil (2007) determined and
compared prevalence of anxiety disorder among patients with essential hypertension
and a control group. The structured clinical interview (SCID I) was administered
(anxiety disorder module) to 157 people including 57 essential hypertensive patients
(non diabetics, without CVA and or other complications) and 100 controls (non
hypertensive people that converge to the hospital).They observed a higher frequency of
anxiety disorder in the hypertensive group than in the control group (p <0.001).
37
Yasunari , Matsui , Maeda , Nakamura , Watanabe and Kiriike (2006)
examined the hypothesis that anxiety and depression lead to increased plasma
catecholamines and to production of reactive oxygen species (ROS) by mononuclear
cells (MNC) in hypertensive individuals. They also studied the role of BP in this effect.
In Protocol 1, a cross-sectional study was performed in 146 hypertensive patients to
evaluate whether anxiety and depression affect BP and ROS formation by MNC
through increasing plasma catecholamines. In Protocol 2, a 6-month randomized
controlled trial using a subtherapeutic dose of the alpha(1)-adrenergic receptor
antagonist doxazosin (1 mg/day) versus placebo in 86 patients with essential
hypertension was performed to determine whether the increase in ROS formation by
MNC was independent of BP. In Protocol 1, a significant relationship was observed
between the following: trait anxiety and plasma norepinephrine (r = 0.32, P < .01);
plasma norepinephrine and ROS formation by MNC (r = 0.36, P < .01); and plasma
norepinephrine and systolic, diastolic, and mean BP (r = 0.17, P = .04; r = 0.26, P = .02;
r = 0.23, P < .01, respectively). In Protocol 2, subtherapeutic doxazosin treatment (1
mg/day) had no significant effect on BP.
Vicario, Martinez, Baretto, Diaz Casale and Nicolosi (2005) studied sixty
hypertensive patients, aged 65-80 years, compared with 30 normotensive individuals
for recall scores. Neither gender differences, duration of hypertension (10.2+/-8.2
years), nor prescribed antihypertensive drug treatment had an influence on study
results. Immediate recall was impaired in both groups. The hypertensive patients
evinced impairment in all tests vs. the normotensive subjects. Mean deferred recall
scores +/- SD were 5.68+/-2.6 vs. 7.13+/-2.4; p<0.01. Deficits in attention speed and
executive function, as measured by non-performance on the Trail Making Test Part B,
38
were present in 46% of hypertensive patients vs. 13% of normotensive patients
(p<0.005), with more errors made by the hypertensive patients (1.15+/-1.54 vs. 0.46+/-
0.9; p<0.02). Scores on the Stroop Color and Word Test also revealed deficits in the
hypertensive patients (24.7+/-7.6 vs. 32+/-10.7; p<0.005). Compared with the control
group, the hypertensive participants revealed more deficits in skills involving delayed
recall and prefrontal-region skills.
Section D: Cognitive behaviour therapy for the anxiety triad.
Sarris et al. (2012) did a meta review with an objective to examine evidence
across a broad range of CAM and lifestyle interventions in the treatment of anxiety
disorders. In early 2012 they conducted a literature search of PubMed, Scopus,
CINAHL, Web of Science, PsycInfo, and the Cochrane Library, for key studies,
systematic reviews, and meta analyses in the area. The paper found that in respect to
treatment of generalized anxiety or specific disorders, CAM evidence revealed current
support for the herbal medicine Kava. One isolated study shows benefit for
naturopathic medicine, whereas acupuncture, yoga, and Tai chi have tentative
supportive evidence, which is hampered by overall poor methodology. The breadth of
evidence does not support homeopathy for treating anxiety. It was also identified that
strong support existed for lifestyle modifications including adoption of moderate
exercise and mindfulness meditation, whereas dietary improvement, avoidance of
caffeine, alcohol, and nicotine offer encouraging preliminary data. In conclusion,
certain lifestyle modifications and some CAMs may provide a beneficial role in the
treatment of anxiety disorders.
39
Chen et al. (2012) screened over 1,000 abstracts and reviewed 200+ full
articles. Only randomized controlled trials were included. The Boutron checklist to
evaluate a report of a non pharmaceutical trial (CLEAR-NPT) was used to assess study
quality; 90% of the authors were contacted for additional information. Review Manager
5 was used for meta-analysis. A total of 36 RCTs were included in the meta-analysis
(2,466 observations). Most RCTs were conducted among patients with anxiety as a
secondary concern. Twenty-five studies reported statistically superior outcomes in the
meditation group compared to control. No adverse effects were reported. This review
demonstrates some efficacy of meditative therapies in reducing anxiety symptoms,
which has important clinical implications for applying meditative techniques in treating
anxiety.
Bystritsky et al. (2012) examined a large sample of patients with anxiety and
the association between types of complementary and alternative treatments that were
used, demographic variables, diagnostic categories, and treatment outcomes.
Interviewer-administered questionnaires via a centralized telephone survey by blinded
assessment raters. The interviews were done at baseline, 6, 12, and 18 months of the
study. A total of 1004 adults ages 18-75 who met DSM-IV criteria for Generalized
Anxiety Disorder (GAD), Panic Disorder, Social Anxiety Disorder, or Post-Traumatic
Stress Disorder. They assessed medication/herbal use, the use of any alternative
therapies, and combined Complementary and Alternative Medicine (CAM) use. They
found an extensive (43%) use of a variety of CAM treatments that is consistent with
previous study results in populations with anxiety. Users most often had a diagnosis of
GAD, were older, more educated, and had two or more chronic medical conditions.
40
Chung , Brooks , Rai , Balk and Rai (2012) investigated the effect of Sahaja
yoga meditation on quality of life, anxiety, and blood pressure control. The prospective
observational cohort study enrolled two study groups: (meditation group) and (control
group). Researchers measured quality of life, anxiety, and blood pressure before and
after treatment. Sixty-seven (67) participants in the meditation group and 62
participants in the control group completed the study. The two groups were comparable
in demographic and clinical characteristics. At baseline, the meditation group had
higher quality of life (p<0.001) than controls but similar anxiety level (p=0.74) to
controls. Within-group pre- versus post-treatment comparisons showed significant
improvement in quality of life, anxiety, and blood pressure in the meditation group
(p<0.001), while in controls, quality of life deteriorated and there was no improvement
in blood pressure. The improvement in quality of life, anxiety reduction, and blood
pressure control was greater in the meditation group.
Ko, Lin (2012) aimed to investigate the effect of a relaxation tape on levels of
anxiety in surgical patients with a one-group pretest-post-test quasi-experimental
design. The patients were given relaxation tapes the day before their scheduled surgery.
Tests were conducted before and after patients listened to the tapes. STAI and
respiration, pulse and blood pressure were used to collect data measurements on the
anxiety level of these patients. The average age of 80 patients was 43·14 (SD 17·27)
years. After the patients listened to the relaxation tape, their respiration rate dropped
from 18·4 (SD 6·9) -17·8 (SD 7·4), pulse rate dropped from 81·9 (SD 33·5) - (SD
33·7), systolic blood pressure decreased from 125·4 (SD 16) mmHg - 121·5 (SD 13·4)
mmHg and STAI score dropped from 50·9 (SD 11·1) - 41·1 (SD 9·8). They all showed
a significant level of difference (p < 0·05). The results showed that a relaxation tape
41
can significantly reduce the level of anxiety and vital signs related to anxiety in surgical
patients.
Busch, Magerl, Kern, Haas, Hajak and Eichhammer (2012) in order to
disentangle the effects of relaxation and respiration, investigated two different DSB
techniques at the same respiration rates and depths on pain perception, autonomic
activity, and mood in 16 healthy subjects. In the attentive DSB intervention, subjects
were asked to breathe guided by a respiratory feedback task requiring a high degree of
concentration and constant attention. In the relaxing DSB intervention, the subjects
relaxed during the breathing training. The skin conductance levels, indicating
sympathetic tone, were measured during the breathing maneuvers. Thermal detection
and pain thresholds for cold and hot stimuli and profile of mood states were examined
before and after the breathing sessions. The mean detection and pain thresholds showed
a significant increase resulting from the relaxing DSB, whereas no significant changes
of these thresholds were found associated with the attentive DSB. The mean skin
conductance levels indicating sympathetic activity decreased significantly during the
relaxing DSB intervention but not during the attentive DSB. Both breathing
interventions showed similar reductions in negative feelings (tension, anger, and
depression). Results suggested that the way of breathing decisively influences
autonomic and pain processing, thereby identifying DSB in concert with relaxation as
the essential feature in the modulation of sympathetic arousal and pain perception.
Reinecke, Hoyer, Rinck and Becker (2012) investigated whether generalized
anxiety disorder (GAD) is susceptible to cognitive-behavioural treatment (CBT). 22
GAD patients and 22 healthy controls (HC) were tested twice within 15 weeks, with
patients receiving CBT in between. A subset of patients was additionally tested while
42
waiting for treatment to control for retest effects. Using a mental control paradigm, they
measured intrusion frequency during the voluntary suppression of thoughts related to
(a) the individual main worry topic, (b) a negative non-worry topic, and (c) a neutral
topic. Self-reported worry was measured before and after treatment, and at 6-months
follow-up. Compared to HC, GAD showed specifically more worry-related intrusions.
CBT reduced this bias to a healthy level, over and above mere test-retest effects.
Norton and Barrera (2012) conducted a randomized clinical trial examining
the efficacy of a 12-week trans diagnostic cognitive- behavioral group treatment in
comparison to 12-week diagnosis-specific group Cognitive-Behavioral Therapy (CBT)
protocols for panic disorder, social anxiety disorder, and generalized anxiety disorder.
Results from 46 treatment initiators suggested significant improvement during
treatment, strong evidence for treatment equivalence across transdiagnostic and
diagnosis-specific CBT conditions, and no differences in treatment credibility. This
study provided evidence supporting the efficacy of transdiagnostic CBT by comparison
to current gold-standard diagnosis-specific CBT for social anxiety disorder, generalized
anxiety disorder, and panic disorder.
Hedman, Andersson, Lindefors, Andersson, Rück and Ljótsson (2012)
investigated the cost-effectiveness and 1-year treatment effects of ICBT for severe
health anxiety. Cost-effectiveness and 1-year follow-up data were obtained from a
randomized controlled trial comparing ICBT (n=40) to an attention control condition
(CC, n=41). The primary outcome measure was the Health Anxiety Inventory (HAI). A
societal perspective was taken and incremental cost-effectiveness ratios (ICERs) were
calculated using bootstrap sampling. Baseline to 1-year follow-up effect sizes on the
43
primary outcome measure were large (d=1.71-1.95). ICBT is a cost-effective treatment
for severe health anxiety that can produce substantial and enduring effects.
Cutshall et al. (2011) assessed whether a self-directed, computer-guided
meditation training program is useful for stress reduction in hospital nurses. They
prospectively evaluated participants before and after a month-long meditation program.
The meditation program consisted of 15 computer sessions that used biofeedback to
reinforce training. Participants were instructed to practice the intervention for 30
minutes per session, four times a week, for four weeks. Visual analogue scales were
used to measure stress, anxiety, and quality of life (assessments were performed using
Linear Analogue Self-Assessment [LASA], State Trait Anxiety Inventory [STAI], and
Short-Form 36 [SF-36] questionnaires). Differences in scores from baseline to the
study's end were compared using the paired t test. Eleven registered nurses not
previously engaged in meditation were enrolled; eight completed the study. Intent-to-
treat analysis showed significant improvement in stress management, as measured by
SF-36 vitality subscale (P = .04), STAI (P = .03), LASA stress (P = .01), and LASA
anxiety (P = .01). Nurses were highly satisfied with the meditation program, rating it
8.6 out of 10.The results of this pilot study suggest the feasibility and efficacy of a
biofeedback-assisted, self-directed, meditation training program to help hospital nurses
reduce their stress and anxiety. Optimal frequency of use of the program, as well as the
duration of effects, should be addressed in future studies.
Sherman et al. (2010) evaluated the effectiveness of therapeutic massage for
persons with generalized anxiety disorder (GAD).Sixty-eight persons with GAD were
randomized to therapeutic massage (n=23), thermotherapy (n=22), or relaxing room
therapy (n=23) for a total of 10 sessions over 12 weeks. Mean reduction in anxiety was
44
measured by the Hamilton Anxiety Rating Scale (HARS). Secondary outcomes
included 50% reduction in HARS and symptom resolution of GAD, changes in
depressive symptoms (Patient Health Questionnaire (PHQ-8)), worry and GAD-related
disability. They compared changes in these outcomes in the massage and control
groups posttreatment and at 6 months using generalized estimating equation (GEE)
regression. All groups had improved by the end of treatment (adjusted mean change
scores for the HARS ranged from -10.0 to -13.0; P<.001) and maintained their gains at
the 26-week followup. Massage was not superior to the control treatments, and all
showed some clinically important improvements, likely due to some beneficial but
generalized relaxation response.
Bertisch, Wee, Phillips and McCarthy (2009) analyzed data on MBT use
from the 2002 National Health Interview Survey Alternative Medicine Supplement
(n=31,044). MBT included relaxation techniques (deep breathing exercises, guided
imagery, meditation, and progressive muscle relaxation), yoga, tai chi, and qigong. To
identify medical conditions associated with use of MBT overall and of individual MBT,
they used multivariable models adjusted for socio-demographic factors, insurance
status, and health habits. Among users of MBT (n=5170), they assessed which medical
conditions were most frequently treated with MBT, additional rationale for using MBT,
and perceived helpfulness. They found a positive association between MBT use and
several medical conditions including various pain syndromes and anxiety/depression.
Among adults using MBT to treat specific medical conditions, MBT was most
commonly used for anxiety/depression and musculoskeletal pain syndromes. More than
50% of respondents used MBT in conjunction with conventional medical care, and
20% used MBT for conditions they thought conventional medicine would not help.
45
Bradt and Dileo (2009) tried to examine the effects of music interventions with
standard care versus standard care alone on psychological and physiological responses
in persons with CHD. They searched the Cochrane Central Register of Controlled
Trials (CENTRAL), MEDLINE, CINAHL, EMBASE, PSYCINFO, LILACS, Science
Citation Index, www.musictherapyworld.net, CAIRSS for Music, Proquest Digital
Dissertations, ClinicalTrials.gov, Current Controlled Trials, and the National Research
Register (all to May 2008). They hand searched music therapy journals and reference
lists, and contacted relevant experts to identify unpublished manuscripts. They included
all randomized controlled trials that compared music interventions and standard care
with standard care alone for persons with CHD. Data were extracted, and
methodological quality was assessed, independently by the two reviewers. Twenty-
three trials (1461 participants) were included. Music listening was the main
intervention used, and 21 of the studies did not include a trained music therapist.
Results indicated that music listening has a moderate effect on anxiety in patients with
CHD, however results were inconsistent across studies.
Singh et al. (2009) aimed to evaluate the acute effects of music and progressive
muscle relaxation (PMR) in hospitalized COPD subjects after a recent episode of
exacerbation. A Randomized controlled study was performed of pre-test post-test
design after recruiting 82 COPD subjects from K.M.C hospitals. All patients were
admitted for acute exacerbation and were medically stabilized. After being screened for
the inclusion and exclusion criteria, 72 subjects were selected for the study. Music
group listened to a self selected music of 60-80 beats per minute for 30 minutes. PMR
group practiced relaxation through a pre-recorded audio of instructions of 16 muscle
groups. Outcome variables were Spielberger's state anxiety inventory (SSAI),
46
Spielberger's trait anxiety inventory (STAI), dyspnea, systolic blood pressure (SBP),
diastolic blood pressure (DBP), pulse rate (PR) and respiratory rate (RR). There was
statistically significant main effect across the sessions for state anxiety (F = 62.621, p =
0.000), trait anxiety (F = 19.528, p = 0.000), dyspnea (F = 122.227, p = 0.000), SBP (F
= 63.885, p = 0.000), PR (F = 115.780, p = 0.000) and RR (F = 202.977, p = 0.000).
There was statistically significant interaction effect between the two groups for state
anxiety (F = 6.024, p = 0.003), trait anxiety (F = 8.222, p = 0.000), dyspnea (F =
10.659, p = 0.000), SBP (F = 12.889, p = 0.000), PR (F = 4.746, p = 0.008) and RR (F
= 12.078, p = 0.000). Music and PMR are effective in reducing anxiety and dyspnoea
along with physiologic measures such as SBP, PR and RR in two sessions in COPD
patients hospitalized with exacerbation. However, reductions in the music group were
greater compared to the PMR group.
Yook et al. (2008) examined the usefulness of a mindfulness-based cognitive
therapy (MBCT) for treating insomnia symptoms in patients with anxiety disorder.
Nineteen patients with anxiety disorder were assigned to an 8-week MBCT clinical
trial. Participants showed significant improvement in Pittsburgh Sleep Quality Index (Z
= -3.46, p = 0.00), Penn State Worry Questionnaire (Z = -3.83, p = 0.00), Ruminative
Response Scale (Z = -3.83, p = 0.00), Hamilton Anxiety Rating Scale (Z = -3.73, p =
0.00), and Hamilton Depression Rating Scale scores (Z = -3.06, p = 0.00) at the end of
the 8-week program as compared with baseline. Multiple regression analysis showed
that baseline Penn State Worry Questionnaire scores were associated with baseline
Pittsburgh Sleep Quality Index scores. These findings suggest that MBCT can be
effective at relieving insomnia symptoms by reducing worry associated sleep
disturbances in patients with anxiety disorder.
47
Evans, Ferrando, Findler, Stowell, Smart and Haglin (2008) recruited
eligible subjects to a major academic medical center participated in the group MBCT
course and completed measures of anxiety, worry, depressive symptoms, mood states
and mindful awareness in everyday life at baseline and end of treatment. Eleven
subjects (six female and five male) with a mean age of 49 (range=36-72) met criteria
and completed the study. There were significant reductions in anxiety and depressive
symptoms from baseline to end of treatment. MBCT may be an acceptable and
potentially effective treatment for reducing anxiety and mood symptoms and increasing
awareness of everyday experiences in patients with GAD.
Section E: Literature regarding biofeedback on anxiety
Prinsloo, Rauch, Karpul and Derman (2013) examined the effect of heart rate
variability (HRV) biofeedback on measures of electroencephalogram (EEG) during and
immediately after biofeedback. Eighteen healthy males exposed to work-related stress,
were randomised into an HRV biofeedback (BIO) or a comparative group (COM). EEG
was recorded during the intervention and during rest periods before and after the
intervention. Power spectral density in theta, alpha and beta frequency bands and
theta/beta ratios were calculated. During the intervention, the BIO group had higher
relative theta power [Fz and Pz (p < 0.01), Cz (p < 0.05)], lower fronto-central relative
beta power (p < 0.05), and higher theta/beta [Fz and Cz (p < 0.01), Pz (p < 0.05)] than
the COM group. The findings of this study suggested that a single session of HRV
biofeedback after a single training session was associated with changes in EEG
suggestive of increased internal attention and relaxation both during and after the
intervention.
48
Wells, Outhred, Heathers, Quintana and Kemp (2012) studied a total of 46
trained musicians and were randomly allocated to a slow breathing with or without
biofeedback or no-treatment control group. A 3 Group×2 Time mixed experimental
design was employed to compare the effect of group before and after intervention on
performance anxiety (STAI-S) and frequency domain measures of HRV. Slow
breathing groups (n=30) showed significantly greater improvements in high frequency
(HF) and LF/HF ratio measures of HRV relative to control (n=15) during 5 minute
recordings of performance anticipation. Participants with high baseline anxiety who
received the intervention (n=15) displayed greater reductions in self-reported state
anxiety relative to those in the control condition (n=7) (r=0.379). These findings
indicated that slow breathing was particularly helpful for musicians with high levels of
anxiety.
Ratanasiripong, Ratanasiripong and Kathalae (2012) assessed 60 second-
year baccalaureate nursing students. The 30 participants in the biofeedback group were
given training on how to use the biofeedback device to assist in stress and anxiety
management for 5 weeks while the 30 in the control group did not receive any training.
Results indicated that the biofeedback group was able to maintain the stress level while
the control group had a significant increase in the stress level over the 5-week period of
clinical training. Additionally, the biofeedback group had a significant reduction in
anxiety, while the control group had a moderate increase in anxiety.
Sutarto, Wahab and Zin (2012) conducted a study to examine the effect of
resonant breathing biofeedback training for reducing stress among manufacturing
operators. Thirty-six female operators from an electronic manufacturing factory were
randomly assigned as the experimental group (n = 19) and the control group (n = 17).
49
The participants of the intervention received 5 weekly sessions of biofeedback training.
Physiological stress profiles and self-perceived depression, anxiety, and stress scale
(DASS) were assessed at pre- and post-intervention. Results indicated that depression,
anxiety, and stress significantly decreased after the training in the experimental group;
they were supported by a significant increase in physiological measures. Overall, these
results supported the potential application of resonant biofeedback training to reduce
negative emotional symptoms among industrial workers.
Nilsson, Lundh, Faghihi and Roth-Andersson (2011) asked forty socially
anxious participants to give a speech, then to listen to and evaluate a taped recording of
their performance. Half of the sample was given cognitive preparation prior to the
audio feedback and the remainder received audio feedback only. Cognitive preparation
involved asking participants to (1) predict in detail what they would hear on the
audiotape, (2) form an image of themselves giving the speech and (3) listen to the audio
recording as though they were listening to a stranger. To assess generalization effects
all participants were asked to give a second speech. Audio feedback with cognitive
preparation was shown to produce less negative ratings after the first speech, and
effects generalized to the evaluation of the second speech. More positive speech
evaluations were associated with corresponding reductions of state anxiety. Social
anxiety as indexed by the Implicit Association Test was reduced in participants given
cognitive preparation.
Mikosch et al. (2010) conducted a study to evaluate the value of psychological
assistance including respiratory-sinus-arrhythmia biofeedback training in its ability to
reduce the level of anxiety in patients undergoing coronary angiography. 212 patients
50
undergoing routine elective coronary angiography for the evaluation of stable coronary
artery disease were randomized into two groups. In the psychological support group (n
= 106) a structured psychological conversation and respiratory-sinus-arrhythmia
biofeedback training were offered prior to coronary angiography. In the control group
(n = 106) standard care and information was provided without psychological support.
State-anxiety was measured (scale 20-80) 1 day prior to and after coronary
angiography, along with blood pressure and heart rate. Prior to coronary angiography,
state-anxiety was 54.8 +/- 11.5 (mean +/- SD) in the control group and 54.8 +/- 12.6 in
the psychological support group. After coronary angiography, state-anxiety was 47.9
+/- 18.5 in the control group but 28.3 +/- 12.5 in the psychological support group
(Wilcoxon rank sum test W = 7272, P < 0.001). Blood pressure was significantly lower
in the psychological support group prior to the intervention and the day after coronary
angiography.
Rodebaugh, Heimberg , Schultz and Blackmore (2010) tested video feedback
with cognitive preparation among treatment-seeking participants with a primary
diagnosis of social anxiety disorder. In Session 1, participants gave an extemporaneous
speech and either received the intervention or not. In Session 2, 6-14 days later,
participants gave a second extemporaneous speech. The intervention improved self-
perception of performance, particularly for those participants with the most
unrealistically negative impressions of their performance (i.e., high self-observer
discrepancy). In addition, the intervention reduced anticipatory anxiety for the second
speech for participants with high self-observer discrepancy. These findings suggested
that the intervention may be useful for people with social anxiety disorder and higher
self-observer discrepancies for a specific task.
51
Henriques, Keffer, Abrahamson and Horst (2011) explored the effectiveness
of a computer-based heart rate variability biofeedback program on reducing anxiety and
negative mood in college students. A pilot project (n = 9) of highly anxious students
revealed sizable decreases in anxiety and negative mood following utilizing the
program for 4 weeks. A second study (n = 35) employing an immediate versus delayed
treatment design replicated the results, although the magnitude of the impact was not
quite as strong.
Bhat (2010) carried out a study in multispecialty Command Hospital by
enrolling 100 patients with psychiatric diagnosis from both inpatient and outpatient
services. The anxiety level was assessed clinically and by using Hamilton Anxiety
Scale and Taylor's Manifest Anxiety Scale. One group of 50 patients was treated with
Alfa EEG biofeedback sessions only, 5 times in a week for 8 weeks, along with specific
pharmacotherapy. The other group was treated with appropriate dose of anxiolytics.
The anxiety level was reassessed after 4 weeks and 8 weeks. The response was better
for mixed anxiety and depressive disorder with pharmacotherapy than with the
biofeedback, but female patients showed better response with EEG biofeedback. Alfa
EEG biofeedback therapy was almost as efficacious as pharmacological intervention in
the management of anxiety symptoms, and relatively more useful in females.
Reiner (2008) examined the effectiveness of a portable Respiratory Sinus
Arrhythmia (RSA) biofeedback device as an adjunct to CBT in persons with anxiety
disorders and other disorders associated with autonomic dysfunction attending
outpatient treatment. Participants were 24 individuals attending outpatient cognitive
behavioural treatment for a range of anxiety disorders. Participants were assessed over
a 3 week period. Outcomes included measures of anxiety (STAI-Y), sleep disturbances
(PSQI), anger (STAEI), and subjective questions about the effectiveness of the device
52
as a treatment adjunct. Significant reductions were found for anxiety and anger and for
certain sleep variables (e.g. sleep latency). There was a significant dose-effect in that
those who were more compliant had significantly greater reductions in most domains
including sleep, anger and trait anxiety. These results suggested that portable RSA
biofeedback was a promising treatment adjunct for disorders of autonomic arousal and
is easily integrated into treatment
Michael, Krishnaswamy and Mohamed (2005) tried to establish the
effectiveness of EEG biofeedback using beta training as a relaxation technique and
ultimately reducing anxiety levels of patients with confirmed unstable angina or
myocardial infarction. Patients with confirmed unstable angina or myocardial infarction
referred by cardiologists were recruited 2-3 days after their cardiac event from the
cardiology wards. Their initial anxiety scores were determined using the Hospital
Anxiety and Depression Scale. Those that returned for therapy underwent instrument
feedback training using EEG every two weeks for a total of five sessions. EEG
frequencies were measured for all sessions. Dropouts who did not participate in the
program agreed to return 3 months later for the second psychological assessment. The
study design was uncontrolled. Subjects had significantly lower anxiety scores at the
second screening (p < 0.001), while the dropouts had significantly higher scores (p <
0.001). Beta training was effective in increasing sensory motor rhythm (SMR) waves
but no significant effect was present for the alpha waves.
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3.2 CONCEPTUAL FRAMEWORK
Health is described as a positive state of well being in which a person is
productive to his maximum level. He sustains his effort to maintain this state and
contribute to the wellness of his co-beings and society. The concept of health is also
accepted as a complex interaction of personal, environmental, psychological and
social factors. Chummun (2009) has implied that patients with arterial hypertension
require support to adhere successfully to their prescribed therapeutic regimen, and
nurses have the leading role in providing relevant information to encourage the
empowerment of patients with this disease. After exploring various theoretical
contexts, the investigator opted for Nola J Pender’s Modified Health Promotion
Model (1996) as means to guide the patients with hypertension. Nola J Pender is the
theorist who described and emphasized the importance of contributing factors to a
person’s health and his commitment to maintain and promote healthy behaviour.
The major concepts covered in the model are
Individual characteristics
Behaviour specific cognitions and affect
Behaviour outcomes
Individual characteristics are personal elements which are non- modifiable
or modifiable and has a positive health outcome. They include demographic
characteristics, personality traits, health behaviours, and willingness to adopt and
sustain healthy behaviours, personal inclination to one’s own health and
commitment to the well being of the society.
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Aspects such as age, sex, BMI, FBS, cholesterol levels, smoking /
alcoholism, physical activity and lifestyle, menopause, dietary pattern,
antihypertensive medications and doses etc. play a role in the level of blood pressure
of an individual. Blood pressure level is also influenced by psychological factors like
anxiety (state and trait), perception on health, perceived health status and self
motivation to practice life style modifications. Socio- cultural background of the
patients constituted by educational status, area of residence, monthly income, type of
family and social support also exert an effect on blood pressure.
Behaviour specific cognitions and affect describe the way an individual
mentally process a selected input and his ability to translate that cognitive process
into an action. Numerous factors may influence a behaviour of an individual in
relation to a mental concept. One’s understanding of the possible benefits in
practicing a particular action, perception of the possible hindrances to continue the
behaviour if he chooses to pursue it, self confidence to sustain the action even in the
absence of hindrances and ability to overcome any negative feelings or setbacks
after he started up are examples of cognitive process. Cognition and related affect
are also influenced by modifying factors like situational and interpersonal elements.
This is a fitting concept because human being can be best influenced by a peer, a
professional or media as is he a social being, constantly in interaction with
surroundings.
The subcomponents identified for this selected group of patients in the
cognitive-affective aspect are perceived health status, perceived self efficacy,
perceived barriers to action, activity related affect and modifying factors.
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Perceived health status
A known hypertensive patient’s awareness about the disease, drug
compliance and follow-up, dietary restrictions etc. are assumed to be adequate since
they are well-informed by the consulting physician. But most of the patients are
unaware of the possible benefits of a relaxation therapy. So apart from the routine
care, the investigator impart knowledge and skill on abdominal breathing and
biofeedback over a period of one month with four learning sessions. This is followed
by a schedule of relaxation at home (20 minutes every day and noting down the time
of practice in the diary provided). The learning sessions are supplemented by once a
month reinforcement for three times. The intervention includes fortnightly telephonic
reminders to the study group patients. The effect of the intervention is assessed at the
end of first, second and third month of selecting the patient. The benefits of the
intervention like lowering of blood pressure and anxiety, prevention of complications,
reduction of dose of medications and thus lesser cost of treatment are also explained
to the patient.
Perceived self- efficacy
Patients are helped to identify a time slot suitable for practice of relaxation at
home after their daily choirs. They are guided to stick on to the same timing everyday
to establish a routine. The participants clarify their doubts from the investigator as
needed to improve their practice.
Perceived barriers to action
Out patients commonly present with difficulty to report for follow-up on
scheduled days because of their domestic commitments or other planned
appointments. It is expected that the participants are resourceful to overcome such
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difficulties by making necessary changes in the schedule with the investigator’s help.
The investigator has planned to accommodate the patients who report one or two days
before or after the schedule by relaxing the reporting days for a short period
Activity related affect
Patients experience relaxation, better energy levels and calmness after the
intervention . This will motivate them to carry on further. The interested participants
are the low defaulters. The patients who feel that the intervention schedule is difficult
or who have hesitation will get more frequent telephonic reinforcement to continue in
the study.
Modifying factors
Interpersonal influences
In the health context, the major figure who influences a patient is the
consulting physician. The nurse investigator also motivate on medication compliance,
life style modification, relaxation therapy and regular follow-up. Media and peers as
well inspire the participants. In this study, an immediate family member is assigned to
motivate the patient to adhere to the relaxation plan at home. It is also assumed that
the scheduled telephone reinforcement will improve the adherence to the relaxation
practice.
Situational influences
The environment of the intervention room is maintained noise-free and non-
distracting. The objective evidence of relaxation (the number of green lines appearing
on the screen of biofeedback machine) motivates the patient to relax better and to
maintain the relaxation at the desired level for long. At home, the patient is instructed
to be calm, in clean dress in a clean room preferably with shut doors and recollect the
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level of relaxation achieved with the machine. These make the exercise a pleasurable
one at home.
Behavioural outcome is the final concept described in this theory. The
outcomes can be as desired or anything less than that. The likelihood of any of these
options depend on selected elements like immediate commitment to plan of action
and competing demands/ preferences. Commitment encompasses the readiness to
follow reminders and scheduled follow ups, regular home practice, interaction with
health professionals etc. Competing preferences/ demands are two sets of situations
on which the person has good control or least control in spite of his commitments to
action.
Commitment to a plan of action
The patient is helped to hold on to the intervention plan, drug compliance,
interaction with medical personnel, and regular follow-up (for reassessment and
reinforcement), daily home practice and reminders to achieve the best results.
Telephonic reinforcement and pre-scheduled follow-up days help the patients to
remain committed .
Immediate competing demands and preferences
Some of the patients can not comply with the intervention schedule fully,
though they are well motivated. Such situations include travelling to far places, family
functions and rarely running out of fund to buy medications etc. Patients can
compensate for these situations by making alternate feasible timings and being more
adherent to the life style modifications.
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Health promoting behaviours
They are the endpoints or actions directed towards attaining positive health
outcome such as optimal well-being, personal fulfilment, and productive living. The
positive outcomes expected in the study are lowered blood pressure, less anxiety, dose
reductions of antihypertensive medications, and fewer hospitalisations for
hypertension related complications. It is assumed that patients with hypertension will
positively adhere to life style modifications and the relaxation therapy to effect
desired health outcomes.
Non modifiable
factors
Age, Sex, Area of
residence, Education,
Income per month,
Social support,
Menopausal status
Type of personality
Modifying factors
- Interpersonal influences:
Physician advices,
Support/motivation from
family for regular medications,
nutrition advice by medical
personnel, BART intervention
(over four weeks) & telephonic
reminders from investigator
- Situational influences:
Evidence of relaxation from
BF machine, Conducive home
environment & reinforcements
Modifiable factors
BMI, Cholesterol
level, FBS level,
Duration of
hypertension,
Physical activity style,
Alcoholism/ Smoking
Anxiety level
Anti hypertensive
medicines
Cognitive perceptual factors
Benefits: Better BP control, Less
medicines and complications
Barriers: Time constraints, Lack of
motivation, Social commitments,
Cost of commute
Self efficacy: Confidence for daily
practice, Thorough with relaxation
Activity related affect: Feel relaxed
/ calm, Better energy levels
Health promoting
behaviour
Study group
Better BP control
Less anxiety
Dose reductions of
antihypertensive
medications
Less hospitalisations Reduced cost of treatment Control group
No significant change in
Blood Pressure,
Variable levels of
anxiety,
No significant
dose reductions,
Possible hospitalisations
for related complications
Commitment to
plan of action
Drug compliance,
Interaction with physician
& investigator, Regular
follow-up for reassessment
and reinforcement (3 times)
Daily home practice,
Accepting phone reminders
Immediate competing demands :
Travel to distances
Social events
Skipping medicines
Lack of fund
Preferences
Finding time for self
Self reminders, Seeking
alternative from investigator
Interaction with Physician
Compensating for missed
follow-up, Dietary
modifications, Physical
exercise
Figure 2: Conceptual frame work based on Nola J. Pender’s Modified Health Promotion Model (1996)
Patients with
Stage I/stage II
hypertension
Study Group/
Control Group
INDIVIDUAL
CHARACTERISTICS BEHAVIOUR SPECIFIC
COGNITIONS AND AFFECT BEHAVIOUR OUTCOMES
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