Guided Imagery
Guided Imagery
Guided Imagery
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Guided imagery for treating hypertension in pregnancy (Review)
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Guided imagery for treating hypertension in pregnancy (Review)
Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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TABLE OF CONTENTS
HEADER......................................................................................................................................................................................................... 1
ABSTRACT..................................................................................................................................................................................................... 1
PLAIN LANGUAGE SUMMARY....................................................................................................................................................................... 2
SUMMARY OF FINDINGS.............................................................................................................................................................................. 4
BACKGROUND.............................................................................................................................................................................................. 5
OBJECTIVES.................................................................................................................................................................................................. 7
METHODS..................................................................................................................................................................................................... 7
RESULTS........................................................................................................................................................................................................ 11
Figure 1.................................................................................................................................................................................................. 12
Figure 2.................................................................................................................................................................................................. 14
Figure 3.................................................................................................................................................................................................. 15
DISCUSSION.................................................................................................................................................................................................. 16
AUTHORS' CONCLUSIONS........................................................................................................................................................................... 17
ACKNOWLEDGEMENTS................................................................................................................................................................................ 17
REFERENCES................................................................................................................................................................................................ 18
CHARACTERISTICS OF STUDIES.................................................................................................................................................................. 22
DATA AND ANALYSES.................................................................................................................................................................................... 24
Analysis 1.1. Comparison 1 Guided imagery versus quiet rest, Outcome 1 Antihypertensive drug use.......................................... 25
APPENDICES................................................................................................................................................................................................. 25
CONTRIBUTIONS OF AUTHORS................................................................................................................................................................... 25
DECLARATIONS OF INTEREST..................................................................................................................................................................... 25
DIFFERENCES BETWEEN PROTOCOL AND REVIEW.................................................................................................................................... 25
INDEX TERMS............................................................................................................................................................................................... 26
[Intervention Review]
Megumi Haruna1, Masayo Matsuzaki2, Erika Ota3, Mie Shiraishi4, Nobutsugu Hanada5, Rintaro Mori5
1Department of Midwifery and Women’s Health, Division of Health Sciences & Nursing, Graduate School of Medicine, The University of
Tokyo, Tokyo, Japan. 2Department of Children and Women's Health, Osaka University Graduate School of Medicine, Osaka, Japan. 3Global
Health Nursing, Graduate School of Nursing Sciences, St. Luke's International University, Tokyo, Japan. 4Department of Children and
Women's Health, Osaka University, Suita, Japan. 5Department of Health Policy, National Center for Child Health and Development, Tokyo,
Japan
Contact address: Rintaro Mori, Department of Health Policy, National Center for Child Health and Development, 2-10-1 Okura, Tokyo,
166-0014, Japan. [email protected].
Citation: Haruna M, Matsuzaki M, Ota E, Shiraishi M, Hanada N, Mori R. Guided imagery for treating hypertension in pregnancy. Cochrane
Database of Systematic Reviews 2019, Issue 4. Art. No.: CD011337. DOI: 10.1002/14651858.CD011337.pub2.
Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
ABSTRACT
Background
Hypertension (high blood pressure) in pregnancy carries a high risk of maternal morbidity and mortality. Although antihypertensive drugs
are commonly used, they have adverse effects on mothers and fetuses. Guided imagery is a non-pharmacological technique that has the
potential to lower blood pressure among pregnant women with hypertension. Guided imagery is a mind-body therapy that involves the
visualisation of various mental images to facilitate relaxation and reduction in blood pressure.
Objectives
To determine the effect of guided imagery as a non-pharmacological treatment of hypertension in pregnancy and its influence on perinatal
outcomes.
Search methods
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register, and two trials registers (October 2018). We also searched
relevant conference proceedings and journals, and scanned the reference lists of retrieved studies.
Selection criteria
We included randomised controlled trials (RCTs). We would have included RCTs using a cluster-randomised design, but none were identi-
fied. We excluded quasi-RCTs and cross-over trials.
We sought intervention studies of various guided imagery techniques performed during pregnancy in comparison with no intervention or
other non-pharmacological treatments for hypertension (e.g. quiet rest, music therapy, aromatherapy, relaxation therapy, acupuncture,
acupressure, massage, device-guided slow breathing, hypnosis, physical exercise, and yoga).
Main results
We included two small trials (involving a total of 99 pregnant women) that compared guided imagery with quiet rest. The trials were
conducted in Canada and the USA. We assessed both trials as at high risk of performance bias, and low risk of attrition bias; one trial was
at low risk for selection, detection, and reporting bias, while the other was at unclear risk for the same domains.
We could not perform a meta-analysis because the two included studies reported different outcomes, and the frequency of the interven-
tion was slightly different between the two studies. One study performed guided imagery for 15 minutes at least twice daily for four weeks,
or until the baby was born (whichever came first). In the other study, the intervention included guided imagery, self-monitoring of blood
pressure, and thermal biofeedback-assisted relaxation training for four total hours; the participants were instructed to practice the pro-
cedures twice daily and complete at least three relief relaxation breaks each day. The control groups were similar - one was quiet rest, and
the other was quiet rest as bed rest.
None of our primary outcomes were reported in the included trials: severe hypertension (either systolic blood pressure of 160 mmHg or
higher, or diastolic blood pressure of 110 mmHg or higher); severe pre-eclampsia, or perinatal death (stillbirths plus deaths in the first
week of life). Only one of the secondary outcomes was measured.
Low-certainty evidence from one trial (69 women) suggests that guided imagery may make little or no difference in the use of antihyper-
tensive drugs (risk ratio 1.27, 95% confidence interval 0.72 to 2.22).
Authors' conclusions
There is insufficient evidence to inform practice about the use of guided imagery for hypertension in pregnancy.
The available evidence for this review topic is sparse, and the effect of guided imagery for treating hypertension during pregnancy (com-
pared with quiet rest) remains unclear. There was low-certainty evidence that guided imagery made little or no difference to the use of
antihypertensive drugs, downgraded because of imprecision.
The two included trials did not report on any of the primary outcomes of this review. We did not identify any trials comparing guided
imagery with no intervention, or with another non-pharmacological method for hypertension.
Large and well-designed RCTs are needed to identify the effects of guided imagery on hypertension during pregnancy and on other relevant
outcomes associated with short-term and long-term maternal and neonatal health. Trials could also consider utilisation and costs of health
service.
PLAIN LANGUAGE SUMMARY
Some women have long-term high blood pressure, or hypertension, whereas approximately 10% of pregnant women develop high blood
pressure as a complication of pregnancy. Guided imagery is a mind-body therapy that involves the visualisation of various mental images
to facilitate relaxation and reduction in blood pressure. It can be performed by oneself, one-to-one, or in groups with an instructor using
audio or scripts.
High blood pressure during pregnancy is associated with an increased risk of the mother developing pre-eclampsia with proteinuria,
eclampsia with seizures and liver and blood disorders, and kidney failure. The baby of a pregnant woman with high blood pressure is more
likely to be born too soon, be too small, and may need neonatal intensive care. High blood pressure drugs are recommended for women
with severe high blood pressure and pre-eclampsia because of the risk of life-threatening complications, but such drugs can have adverse
effects for the mother (including headache, decreased mental alertness, and exercise intolerance). Such drugs can also cross the placenta
and may affect the unborn baby, and are not generally recommended for pregnant women with mild to moderate high blood pressure,
which is when other ways of managing blood pressure are sought.
Guided imagery is a non-pharmacological technique that could potentially lower blood pressure among pregnant women with hyperten-
sion and improve pregnancy outcomes for the mother and her baby.
We searched for evidence (October 2018) and found two trials (involving 99 women) conducted in Canada and the USA. Both trials com-
pared guided imagery with quiet rest. There were no trials comparing guided imagery with no intervention, or other with another non-
pharmacological method for hypertension.
The two included studies reported different outcomes and the Intervention frequency was slightly different between the two studies. One
study performed guided imagery for 15 minutes at least twice daily for four weeks or until the baby was born (whichever came first). The
other study involved guided imagery, self-monitoring of blood pressure, and thermal biofeedback-assisted relaxation training for a total
of four hours; the women were instructed to practice the procedures twice daily and complete at least three relaxation breaks each day.
The control groups between the two studies were similar - one used quiet rest and the other used quiet rest as bed rest.
Neither trial reported data for our main outcomes of interest: severe hypertension, severe pre-eclampsia, or death of the baby during birth
or within the first week of life. The trials provided data for only one of our secondary outcomes of interest.
Low-certainty evidence from the one trial (69 women) suggests that, compared with quiet rest, guided imagery may make little or no
difference in the use of antihypertensive drugs.
We included two small trials comparing guided imagery with quiet rest. We did not identify any trials comparing guided imagery with no
intervention, or another non-pharmacological treatment for hypertension.
The available evidence for this review is sparse and the effect of guided imagery for treating hypertension during pregnancy (compared
with quiet rest) remains unclear.
The included trials did not report on any of the main outcomes in this review and only provided low-certainty evidence on the uncertain
effect on the use of antihypertensive drugs.
There is insufficient evidence to inform practice about using guided imagery for hypertension in pregnancy.
Large and well-designed studies are needed to identify the effects of guided imagery on hypertension during pregnancy and on other
relevant outcomes associated with the short-term and long-term health of mothers and their babies. The trials should also consider the
use and costs of health services.
Library
Cochrane
Guided imagery compared to quiet rest for treating hypertension in pregnancy
Population: pregnant women (between 30 and 36 weeks’ gestation) with elevated blood pressure
Setting: university medical centre, US Navy hospital, local obstetricians in USA, hospitals in Atlantic Canada
Intervention: guided imagery
Better health.
Informed decisions.
Trusted evidence.
Comparison: quiet rest
Severe hypertension See comment None of the trials reported this out-
come.
Severe pre-eclampsia See comment None of the trials reported this out-
come.
Perinatal death (stillbirths plus See comment None of the trials reported this out-
deaths in the first week of life) come.
Antihypertensive drug use 371 per 1000 472 per 1000 RR 1.27 (95% CI 69 ⊕⊕⊝⊝
(267 to 825) 0.72 to 2.22) low a
(1 RCT)
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is
based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk Ratio;
aDowngraded (-2) for very serious imprecision - small trial and wide confidence intervals
4
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SMO versus 2.2% without SMO) and eclampsia (9.6% with SMO ver- • Physical exercise (Meher 2006a)
sus 0.3% without SMO). The survey showed that a high coverage • Rest or advice to reduce physical activity for normotensive
of essential interventions (e.g. magnesium sulphate for eclampsia) women (Meher 2006b)
did not result in reduced maternal mortality in the targeted health- • Stress management (Jallo 2008)
care facilities (Souza 2013).
• Guided imagery (Moffatt 2006)
Antihypertensive therapy is recommended for women with pre- • Acupuncture (Betts 2003)
eclampsia with severe hypertension who are at risk of life-threat-
ening complications (ACOG 2013). Nutritional supplementation
• Calcium supplementation (Hofmeyr 2010)
However, it may be desirable for mothers to take less antihyper-
tensive drugs to avoid side-effects and potential fetal risks. First- • Magnesium supplements (Makrides 2001)
line antihypertensive drugs during pregnancy include hydralazine, • Antioxidants (Roberts 2010)
methyldopa, nifedipine, and labetalol (Moodley 2011; Mustafa • Zinc supplement (Mahomed 2007)
2012); however, all antihypertensive drugs cross the placenta and
may affect the fetus. Furthermore, antihypertensive drugs have Description of the intervention
adverse side-effects for mothers, including headache, decreased
Guided imagery includes the generation of various mental images
mental alertness, impaired sleep, depression, exercise intolerance,
(Astin 2003), and is a technique of visualisation that aims to facil-
and they can also result in elevated liver function tests (ACOG 2013;
itate relaxation (Daake 1989). These visualisations induce a men-
Mustafa 2012).
tal representation of reality that is a quasi-real psychophysiological
Antihypertensive medications are not recommended for pregnant process with a specific desired goal of a physical or psychological
women with mild to moderate hypertension (ACOG 2013). There is outcome in one's mind without an actual external stimulus (Astin
insufficient evidence to conclude whether antihypertensive med- 2003; Jallo 2008). As a cognitive intervention, the generated im-
ications for mild to moderate hypertension during pregnancy are ages cause responses of the following senses: vision, hearing, taste,
effective, because no data from well-designed randomised con- smell, touch, and body balance, and likewise in the physiological
trolled trials are available to mandate the safe use of antihyperten- and psychological responses that occur under the actual stimu-
sive drugs (Abalos 2014). lus presentation (Jallo 2008; Naparstek 1994). Guided imagery cre-
ates the interaction between body and mind, and the evoked image
In addition, angiotensin receptor blockers (ARBs) used to control leads to a state of relaxation and a targeted condition, such as relief
high blood pressure raise the risk of side-effects in the fetus, includ- of pain (Park 2012).
ing renal agenesis (failure of the kidney to develop during embry-
onic growth) and fetotoxicity (Martin 2005). The session of guided imagery is performed either by oneself, or
one-to-one or in groups with an instructor using audio or scripts
Alternative approaches to lower blood pressure that are free from throughout the visualisation process (Daake 1989). Prerecorded
side-effects could be beneficial to pregnant women. compact discs (CDs) and booklets are often provided to partici-
pants to facilitate self-practice (Gedde-Dahl 2012; Sharpe 2007).
We included definitions of hypertension in pregnancy from the The intervention is non-pharmacological, and is one of several
Cochrane Pregnancy and Childbirth Group's generic protocol for mind-body therapies (MBTs) that are defined as "interventions that
treating pre-eclampsia and its consequences (Duley 2009b). employ various methods to engage the mind's capacity to affect
bodily function and symptoms" (NCCIH 2012), including relaxation,
Prevention and treatment of hypertension in pregnancy meditation, hypnosis, biofeedback, cognitive behavioural therapy,
Pharmacological treatment and psycho-educational approaches other than guided imagery
(Astin 2003). Considerable cross-over exists between the various
• Antihypertensive therapy (beta-blockers, calcium channel MBTs, such as imagery, meditation, and relaxation (Astin 2003). A
blockers) (Abalos 2014; Duley 2013) previous study reported that guided imagery had a positive effect
• Diuretic drugs (Churchill 2007) on pregnancy-health-related outcomes, such as pregnancy prolon-
• Anticoagulants (Duley 2007) gation, psychological well-being, and limiting an increase in blood
• Antiplatelet agents (Duley 2007) pressure (Chuang 2012; Moffatt 2010; Urech 2010).
• Nitric oxide (Meher 2007) Types of guided imagery techniques
• Progesterone (Meher 2006)
• Energetic imagery (Jallo 2008; Naparstek 1994)
Non-pharmacological treatment • Feeling state or pleasant imagery (Jallo 2008; Naparstek 1994)
There is insufficient evidence to make reliable conclusions about • End state imagery (Naparstek 1994)
the usefulness of the following non-pharmacological treatments of • Cellular imagery (Naparstek 1994)
hypertensive disorders during pregnancy. • Physiological imagery (Naparstek 1994)
• Metaphoric imagery (Naparstek 1994)
• Healthy diet, Dietary Approaches to Stop Hypertension (DASH)
diet (Asemi 2013) • Psychological imagery (Naparstek 1994)
• Weight management (Thangaratinam 2012) • Relaxation images, exercise (Jallo 2008; Naparstek 1994)
• Dietary salt restriction, altering salt intake (Duley 1999; Duley
2005)
Guided imagery for treating hypertension in pregnancy (Review) 6
Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cochrane Trusted evidence.
Informed decisions.
Library Better health. Cochrane Database of Systematic Reviews
How the intervention might work 2013; Mannix 1999). However, the effectiveness of guided imagery
for treating hypertension in pregnancy has not been systematically
Guided imagery encompasses relaxation or visualisation tech- reviewed.
niques, or both, in which the individual imagines desirable physi-
cal responses in order to reduce psychological stress and to attain OBJECTIVES
a calm state of mind (Astin 2003). Although previous studies have
suggested that beneficial effects of guided imagery, such as relax- The objective of this systematic review was to determine the effect
ation response and relief of anxiety, have been found to reduce of guided imagery as a non-pharmacological treatment of hyper-
blood pressure (Crowther 1983; Kwekkeboom 1998), the physio- tension in pregnancy and its influence on perinatal outcomes.
logical mechanism of guided imagery in the cardiovascular system
during pregnancy has not yet been clarified. METHODS
Pregnancy induces dramatic physiological changes in the cardio- Criteria for considering studies for this review
vascular system. Increases in blood volume, heart rate, stroke vol-
ume, and cardiac output occur, while systemic vascular resistance Types of studies
and arterial blood pressure decreases (de Weerth 2005; Fu 2009; We included randomised controlled trials (RCTs); quasi-RCTs or
Mustafa 2012). Several studies have shown that maternal psycho- cross-over trials were not eligible for inclusion. Cluster-RCTs were
logical stress can increase arterial blood pressure (Teixeria 1999; eligible, but we did not identify any. Studies presented only as ab-
Vianna 2011). Although the biological pathway associated with psy- stracts, with sufficient information, were also eligible, but we did
chological stress and elevated blood pressure is less clear, pos- not identify any.
sible pathophysiological mechanisms may play a role in activat-
ing the hypothalamic-pituitary-adrenal (HPA) axis and the sympa- Types of participants
thetic–adrenal–medullary (SAM) system that produces glucocorti-
Pregnant women with hypertension, defined as systolic blood pres-
coid hormone and catecholamine responses to psychological stim-
sure greater than or equal to 140 mmHg, or diastolic blood pressure
uli (Johnson 1992; Rozanski 1999). The function of the HPA ax-
greater than or equal to 90 mmHg, or both. We included women
is is associated with increases in the levels of plasma glucocorti-
who were both undergoing drug therapy, and those who were not.
coid hormones, such as cortisol, under the control of the adreno-
corticotropic hormone (ACTH). The secretion of ACTH is regulat- Types of interventions
ed by corticotropin-releasing hormone (CRH), which is secreted
from the hypothalamus, and is associated with the regulation of Various guided imagery techniques performed during pregnancy
a normal response to stress (Johnson 1992). In pregnancy, placen- compared with:
tal CRH stimulates maternal pituitary ACTH secretion, which leads
1. any other non-pharmacological methods for hypertension (e.g.
to increased cortisol levels as gestation progresses, and results
quiet rest, music therapy, aromatherapy, relaxation thera-
in maternal physiological hypercortisolism (de Weerth 2005; Mas-
py, acupuncture, acupressure, massage, device-guided slow
torakos 2003). Even though glucocorticoid hormones physiologi-
breathing, hypnosis, physical exercise, or yoga);
cally increase by the end of gestation, in normal pregnancies, blood
pressure is controlled by the homeostatic function of the neuroen- 2. no intervention.
docrine systems (de Weerth 2005; DiPietro 2005; Johnson 1992). Pa-
Types of outcome measures
tients with hypertensive disorders of pregnancy show higher levels
of mean arterial pressure compared to those with normal pregnan- Primary outcomes
cy (Gaillard 2011) The activation of the sympathetic nervous sys-
Maternal
tem is observed in both chronic hypertension and gestational hy-
pertension compared with normal pregnancy (Grassi 1998; Green- 1. Severe hypertension: defined as either systolic blood pressure
wood 2003). greater than or equal to 160 mmHg, or diastolic blood pressure
greater than or equal to 110 mmHg (other definitions by trialists
Enhanced psychological stress and negative emotional stress in were included)
pregnancy also cause changes in the activity of the HPA axis and 2. Severe pre-eclampsia (pre-eclampsia with severe hypertension,
SAM system (de Weerth 2005; Urech 2010). Conversely, mind-body severe proteinuria (usually at least 3 g (range 2 g to 5 g) pro-
therapies, such as relaxation or imagery techniques, or both, may tein in 24 hours, or 3+ on a dip-stick), reduced urinary vol-
reduce stress responses and negative emotional feelings along ume (less than 500 mL in 24 hours), neurological disturbances,
with modulating sympathetic and parasympathetic activity that such as headache, visual disturbances, and exaggerated ten-
results in cardiovascular system changes, including a reduction don reflexes, upper abdominal pain, pulmonary oedema (flu-
in blood pressure, or the heart rate, or both (Moffatt 2010; Urech id in the lungs), impaired liver function tests, high serum cre-
2010). A previous Cochrane Review suggested that mind-body in- atinine, low platelets (platelet count less than 100,000/mL), in-
terventions during pregnancy might prevent or treat women's anx- trauterine growth restriction, or reduced liquor volume (Brown
iety (Marc 2011). 2000; NHBPEP 2000)
Why it is important to do this review Neonatal
Guided imagery is a simple, non-invasive, and safe technique, 1. Perinatal death (stillbirths plus deaths in the first week of life)
which has the potential to lower blood pressure among pregnant
women with hypertension, and may reduce maternal, fetal, and in-
fant morbidity and mortality in hypertension in pregnancy (Jallo
1. Small-for-gestational age: defined as growth below the third Search results are screened by two people, and the full text of all
centile, or lowest centile reported relevant trial reports identified through the searching activities de-
scribed above is reviewed. Based on the intervention described,
2. Preterm delivery: defined as birth before 37 completed weeks'
each trial report is assigned a number that corresponds to a spe-
gestation
cific Pregnancy and Childbirth review topic (or topics), and is then
3. Neontal death (death in the first 28 days after birth) added to the Register. The Information Specialist searches the Reg-
4. Infant death (death in the first year of life) ister for each review using this topic number rather than keywords.
5. Death before discharge from hospital, or in a special care nurs- This results in a more specific search set that has been fully ac-
ery for more than seven days counted for in the relevant review sections (Included studies; Ex-
6. Severe neonatal morbidity: including respiratory distress syn- cluded studies).
drome, sepsis, necrotising enterocolitis, retinopathy of prema-
In addition, we searched ClinicalTrials.gov and the WHO Interna-
turity, and intraventricular haemorrhage
tional Clinical Trials Registry Platform (ICTRP) for unpublished,
7. Apgar score of less than seven at five minutes planned, and ongoing trial reports (31 October 2018). See Appendix
8. Use of hospital resources: admission to special care nursery, 1 for search methods used.
length of stay, endotracheal intubation, use of mechanical ven-
tilation Searching other resources
a) We handsearched relevant journals; Hypertension in Pregnancy
(1999 to 2017) and Pregnancy Hypertension (2011 to 2017).
b) We searched conference proceedings of national and interna- • low risk of bias (e.g. telephone or central randomisation; con-
tional conferences related to guided imagery interventions; The As- secutively numbered sealed opaque envelopes);
sociation for Music and Imagery (2017) and The European Associa- • high risk of bias (open random allocation; unsealed or non-
tion of Music and Imagery (2014 to 2017). opaque envelopes, alternation; date of birth);
c) We searched the reference lists of retrieved studies. • unclear risk of bias.
Assessment of risk of bias in included studies (4) Incomplete outcome data (assessing for possible attrition
bias due to the amount, nature and handling of incomplete
Two review authors (MH, MM) independently assessed risk of bias outcome data)
for each study, using the criteria outlined in the Cochrane Handbook
for Systematic Reviews of Interventions (Higgins 2011). We resolved For each included study, and for each outcome or class of out-
any disagreement by discussion, or by involving a third assessor comes, we described the completeness of data, including attri-
(EO). tion and exclusions from the analysis. We stated whether attrition
and exclusions were reported, and the numbers included in the
(1) Random sequence generation (assessing for possible analysis at each stage (compared with the total randomised par-
selection bias) ticipants), reasons for attrition or exclusion where reported, and
For each included study, we described the method used to generate whether missing data were balanced across groups, or were related
the allocation sequence in sufficient detail to allow an assessment to outcomes. Where sufficient information was reported, or could
of whether it should produce comparable groups. be supplied by the trial authors, we re-included missing data in the
analyses that we undertook.
We assessed the method as:
We assessed methods as:
• low risk of bias (any truly random process, e.g. random number
table; computer random number generator); • low risk of bias (e.g. no missing outcome data; missing outcome
data balanced across groups);
• high risk of bias (any non-random process, e.g. odd or even date
of birth; hospital or clinic record number); • high risk of bias (e.g. numbers or reasons for missing data im-
balanced across groups; ‘as treated’ analysis done with substan-
• unclear risk of bias. tial departure of intervention received from that assigned at ran-
(2) Allocation concealment (assessing for possible selection bias) domisation);
• unclear risk of bias.
For each included study, we described the method used to con-
ceal allocation to interventions prior to assignment, and assessed (5) Selective reporting (assessing for reporting bias)
whether intervention allocation could have been foreseen in ad-
vance of, or during recruitment, or changed after assignment. For each included study, we described how we investigated the
possibility of selective outcome reporting bias and what we found.
We assessed the methods as:
We assessed the methods as:
• low risk of bias (where it was clear that all of the study's prespec- Measures of treatment effect
ified outcomes and all expected outcomes of interest to the re-
Dichotomous data
view had been reported);
• high risk of bias (where not all the study's prespecified outcomes For dichotomous data, we presented results as summary risk ratio
had been reported; one or more reported primary outcomes with 95% confidence intervals.
were not prespecified; outcomes of interest were reported in-
completely, and so could not be used; study failed to include re- Continuous data
sults of a key outcome that would have been expected to have For continuous data, we used the mean difference if outcomes were
been reported); measured in the same way between trials. We used the standard-
• unclear risk of bias. ised mean difference to combine trials that measure the same out-
come, but use different methods.
(6) Other bias (assessing for bias due to problems not covered by
(1) to (5) above) Unit of analysis issues
For each included study, we described any important concerns we Cluster-randomised trials
had about other possible sources of bias.
Both included studies were individual RCTs, and we did not iden-
We assessed whether each study was free of other problems that tify any cluster-randomised trials for inclusion in this review. In
could put it at risk of bias: future updates, if we identify relevant cluster-randomised trials,
we will include them in the analyses along with individually ran-
• low risk of other bias; domised trials. We will adjust their sample sizes using the methods
• high risk of other bias; described in the Cochrane Handbook for Systematic Reviews of In-
terventions, using an estimate of the intracluster correlation co-ef-
• unclear whether there was risk of other bias.
ficient (ICC) derived from the trial (if possible), from a similar trial,
(7) Overall risk of bias or from a study of a similar population. If we use ICCs from other
sources, we will report this, and conduct sensitivity analyses to in-
We made explicit judgements about whether studies were at high vestigate the effect of variation in the ICC. If we identify both clus-
risk of bias, according to the criteria given in the Cochrane Hand- ter-randomised trials and individually randomised trials, we plan
book for Systematic Reviews of Interventions (Higgins 2011). With to synthesise the relevant information. We will consider it reason-
reference to (1) to (6) above, we assessed the likely magnitude and able to combine the results from both if there is little heterogeneity
direction of the bias, and whether we considered it was likely to between the study designs and the interaction between the effect
impact on the findings. We explored the impact of the level of bias of intervention and the choice of randomisation unit is considered
through undertaking sensitivity analyses - see Sensitivity analysis. to be unlikely. We will also acknowledge heterogeneity in the ran-
domisation unit, and perform a sensitivity analysis to investigate
Assessing the certainty of the evidence
the effects of the randomisation unit.
For this review, we used the GRADE approach to assess the certain-
ty of the body of evidence relating to the following outcomes for Cross-over trials
our comparison of guided imagery compared with quiet rest (Guy- We planed to exclude cross-over trials, as the design is unsuitable
att 2008; Schünemann 2009). for this intervention due to the 'period effect', and the effect of the
first intervention may also extend into the second period.
1. Severe hypertension
2. Severe pre-eclampsia Studies with multiple arms
3. Perinatal death (stillbirths plus deaths in the first week of life) We analysed only the relevant arms that compared guided imagery
4. Antihypertensive drug use (oral antihypertensive, intravenous and the control group, excluding an intervention group without
antihypertensive) guided imagery.
We used GRADEpro GDT to import data from Review Manager 5, Dealing with missing data
in order to create 'Summary of findings' tables (GRADEpro GDT;
RevMan 2014). We produced a summary of the intervention effect For included studies, we noted levels of attrition. In future updates,
and a measure of certainty for each of the above outcomes using we will explore the impact of including studies with high levels
the GRADE approach. The GRADE approach uses five considera- of missing data (over 10% of participants with missing outcomes)
tions (study limitations, consistency of effect, imprecision, indirect- in the overall assessment of treatment effect by using sensitivity
ness, and publication bias) to assess the certainty of the body of analysis.
evidence for each outcome. The evidence can be downgraded from
For all outcomes, we conducted analyses, as far as possible, on
high certainty by one level for serious (or by two levels for very se-
an intention-to-treat basis, i.e. we attempted to include all partic-
rious) limitations, depending on assessments for risk of bias, indi-
ipants randomised to each group in the analyses, and all partici-
rectness of evidence, serious inconsistency, imprecision of effect
pants were analysed in the group to which they were allocated, re-
estimates, or potential publication bias.
gardless of whether or not they received the allocated intervention.
The denominator for each outcome in each trial was the number
randomised minus any participants whose outcomes were known
to be missing.
Assessment of heterogeneity will consider whether an overall summary is meaningful, and if it is,
used random-effects analysis to produce it.
We assessed statistical heterogeneity in each meta-analysis using
the Tau2, I2, and Chi2 statistics. We regarded heterogeneity as sub- We plan to carry out the following subgroup analyses.
stantial if an I2 was greater than 30% and either Tau2 was greater
than zero, or there was a low P value (less than 0.10) for the Chi2 1. Types of hypertensive disorders
test for heterogeneity.
• Chronic versus gestational hypertension or pre-eclampsia
Assessment of reporting biases • Early onset hypertension, which occurs before 32 gestational
In future updates, if there are 10 or more studies in the meta-analy- weeks versus late onset hypertension, which occurs after 32 ges-
sis, we will investigate reporting biases (such as publication bias) tational weeks
using funnel plots. We will assess funnel plot asymmetry visually.
2. Characteristics of guided imagery
If asymmetry is suggested by a visual assessment, we will perform
exploratory analyses to investigate it. • Onset of intervention (early, before 32 weeks versus later, after
32 weeks of gestation)
Data synthesis
• Number of sessions (e.g. less than three times versus more than
We carried out statistical analysis using Review Manager 5 soft- three times)
ware (RevMan 2014). We used a fixed-effect meta-analysis for com-
bining data where it was reasonable to assume that studies were If sufficient data are included in future updates, we will assess sub-
estimating the same underlying treatment effect, i.e. where trials group differences using interaction tests available within Review
were examining the same intervention, and the trials' populations Manager 5 (RevMan 2014). We will report the results of subgroup
and methods were judged sufficiently similar. If there was clin- analyses quoting the Chi2 statistic and P value, and the interaction
ical heterogeneity sufficient to expect that the underlying treat- test, I2, value.
ment effects differed between trials, or if substantial statistical
heterogeneity was detected, we used random-effects meta-analy- Sensitivity analysis
sis to produce an overall summary, if an average treatment effect In future updates, if there is evidence of significant heterogeneity,
across trials was considered clinically meaningful. The random-ef- we will carry out a sensitivity analysis to explore the effects of fixed-
fects summary was treated as the average range of possible treat- effect or random-effects analyses for maternal primary outcomes
ment effects, and we discussed the clinical implications of treat- with statistical heterogeneity, and the effects of any assumptions
ment effects differing between trials. If the average treatment ef- made, such as the value of the ICC used for cluster-randomised tri-
fect was not clinically meaningful, we did not combine trials. If we als. We will perform sensitivity analyses to explore the effects of tri-
used random-effects analyses, the results were presented as the al certainty for the primary outcomes before and after exclusion of
average treatment effect with 95% confidence intervals, and the es- the trials with high or unclear risk of bias for sequence generation,
timates of Tau2 and I2. allocation concealment, or for incomplete outcome data.
Subgroup analysis and investigation of heterogeneity RESULTS
We did not carry out our planned subgroup analysis because of the
absence of data for any of our primary outcomes. Description of studies
Results of the search
In future updates, if we identify substantial heterogeneity in pri-
mary outcomes, we will investigate it using subgroup analyses. We See: Figure 1.
The search of Cochrane Pregnancy and Chilldbirth's Register of tri- (guided imagery; N = 15). We excluded the group of compliance
als identified nine reports of three trials (Moffatt 2006; Somers 1989; enhancement training (N = 15) from this review. The guided im-
Urech 2009). Of these trials, we included two (Moffatt 2006; Somers agery intervention group received a procedure for a total of four
1989), and excluded one (Urech 2009). The additional search iden- hours that involved visual imagery training, thermal biofeed-
tified 16 records, which were either duplicates, or not relevant. back-assisted relaxation training, and self-monitoring of blood
pressure, in addition to the procedures for the control group.
Included studies The control group (N = 15) was prescribed bed rest (quiet rest)
Methods and careful obstetrical monitoring, which is standard obstetri-
cal care for mild pregnancy-induced hypertension (PIH).
We included two individual randomised controlled trials that met
our inclusion criteria (Moffatt 2006; Somers 1989; Characteristics of Outcomes
included studies).
• Moffatt 2006: primary outcome was change in mean arterial
Settings and trial date pressure (MAP). Secondary and other outcomes were change
in average daytime ambulatory systolic blood pressure or dias-
One of the two trials was conducted with women enrolled at two tolic blood pressure and heart rate, proportions of women who
Canadian hospitals; the trial date was between September 2004 received antihypertensive medication, anxiety, time from ran-
and December 2006 (Moffatt 2006). In the other trial, participants domisation to delivery, relationships between blood pressure
were recruited from a large university medical centre, a major US changes and frequency of guided imagery use, means and stan-
Navy hospital, and in three instances, from local obstetricians; the dard deviations of daytime MAP after each week, compliance
trial date was not clear (Somers 1989). levels, and participant satisfactions.
• Somers 1989: primary outcome was MAP ((systolic pressure − di-
Participants
astolic pressure)/3 + diastolic pressure), at the last prenatal visit
• Moffatt 2006: the trial included 69 pregnant women with hy- prior to hospital admission for delivery, and compliance data.
pertension, who were at < 37 weeks’ gestation, with at least
two prenatal diastolic blood pressure readings ≥ 90 mmHg, had Sources of trial funding
clinical investigation for hypertension, and had hearing acuity • Moffatt 2006: “The research was funded through: an Asso-
to hear verbal instructions. Women were excluded if diastolic ciation of Women’s Health, Obstetric and Neonatal Nurses
blood pressure was > 110 mmHg, systolic blood pressure > 170 (AWHONN) Canada/Johnson & Johnson Canada Award, Ottawa,
mmHg, and if they had significant medical conditions. Ontario; the Atlantic Region of the Association of Canadian
• Somers 1989: the trial included 45 pregnant women who were Schools of Nursing, Antigonish, Nova Scotia; the Nursing Re-
between 30 and 36 weeks’ gestation. The eligibility criteria were search Fund, Dalhousie University, Halifax, Nova Scotia; the IWK
as follows: mean arterial pressure (MAP) ≥ 95 mmHg; diastolic Health Centre, Halifax, Nova Scotia; and the Canadian Nurses
blood pressure ≥ 90 mmHg (or an increase of 15 mmHg during Foundation Nursing Care Partnership, Ottawa, Ontario. During
the course of gestation); systolic blood pressure increase of 30 the time of this study, Faith Wight Moffatt also received stu-
mmHg during the course of gestation. Women were excluded if dent funding from: AWHONN, Washington, DC; the Nova Scotia
they had a history of essential hypertension or other blood pres- Health Research Foundation, Halifax, Nova Scotia; the Universi-
sure-related disorders. ty of Toronto, Toronto, Ontario; and the Canadian Institutes of
Health Research Strategic Training Initiative in Research in Re-
Interventions and comparisons productive Health Sciences, Ottawa, Ontario, Canada.”
Two studies compared guided imagery to a control group (quiet • Somers 1989: information regarding sources of trial funding was
rest). not provided in the trial report.
• Moffatt 2006: 96 women were randomised into two groups. The Trial authors' declarations of interest
intervention group received “a standardised 15 minutes guid-
The trial authors' declarations of interest were not provided in the
ed imagery with headphones at least twice daily (for 4 weeks,
two trial reports.
or until childbirth, whichever came first), with or without an au-
dio CD”, whereas the control group received “a standardised ver- Excluded studies
bal introduction to quiet rest and written instructions”, and was
asked to “engage in quiet rest periods for 15 minutes at least One study was excluded from the review because the participants
twice daily (for 4 weeks, or until childbirth, whichever came first) of the study were only healthy pregnant women; women with preg-
without external stimuli, such as reading, watching television, nancy-induced hypertension (PIH), or pre-eclampsia, or both were
listening to music, or engaging in conversation”. not included (Urech 2009; Characteristics of excluded studies).
• Somers 1989: 45 women were randomised into three groups:
bed rest alone (as equal to quiet rest; N = 15), compliance en-
Risk of bias in included studies
hancement training (N = 15), and biobehavioural intervention See Figure 2; Figure 3.
Figure 2. Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages
across all included studies
Figure 3. Risk of bias summary: review authors' judgements about each risk of bias item for each included study
Allocation Blinding of outcome assessment
Sequence generation Moffatt 2006 had a low risk of bias, as the outcome assessors were
not informed of the group allocation or ambulatory blood pressure
Moffatt 2006 had a low risk of bias with adequate allocation, based
data. Somers 1989 had an unclear risk of bias, as no information on
on a random-number generator using a centralised computer.
the outcome assessors' blinding status was available.
Somers 1989 had an unclear risk of bias as no relevant details were
available. Incomplete outcome data
Allocation concealment Both trials had a low risk of bias. In the Moffatt 2006 trial, 31/34
(91%) participants in the guided imagery group and 29/35 (83%)
Moffatt 2006 had a low risk of bias using central allocation, where-
participants in the quiet rest group completed the study. In the
as Somers 1989 had an unclear risk of bias, as no information for
Somers 1989 trial, 15/20 (75%) participants in the intervention
allocation concealment was available.
group and 15/15 (100%) participants in the quiet rest (bed rest
Blinding alone) group were followed up.
study included women with PIH). The trials were conducted some healthy pregnant women; however, systolic blood pressure and di-
time ago (studies were published in 1989 and 2006) and took place astolic blood pressure were not significantly changed by guided im-
in high-income countries (USA and Canada). The studies compared agery. Given that the population were healthy pregnant women, it
the use of guided imagery with a control group. There were differ- is unclear whether the results may generalise to pregnant women
ences between the studies in terms of the intervention frequency with hypertension.
but the control groups were similar. Neither study reported any of
this review's important outcomes - with the exception of one trial A randomised study (Tang 2009) in older adults, showed that guid-
which reported antihypertensive drug use (one of this review's sec- ed relaxation or listening to Mozart, significantly reduced systolic
ondary outcomes). We did not identify any trials comparing guided and diastolic blood pressure but that the effect was greater with
imagery with no intervention, or with another non-pharmacologi- guided relaxation.
cal method for hypertension.
AUTHORS' CONCLUSIONS
Certainy of the evidence
Implications for practice
The overall risk of bias of the two included studies ranged from low
to high. We considered one trial to be at low risk of bias across all There is insufficient evidence to inform practice about the use of
domains, except performance bias, which we assessed at high risk guided imagery for hypertension in pregnancy.
of bias. The other trial was only at low risk for other bias and attri-
tion bias, and was at high risk of performance bias, and unclear risk The available evidence for this review topic is sparse, and the ef-
for the other domains (selection bias and detection bias). fect of guided imagery for treating hypertension during pregnan-
cy (compared with quiet rest) remains unclear. There was low-cer-
We assessed the certainty of the evidence using GRADE for our com- tainty evidence that guided imagery made little or no difference to
parison of guided imagery with the quiet rest (Summary of findings the use of antihypertensive drugs, downgraded because of impre-
for the main comparison). We assessed the evidence for antihyper- cision.
tensive drug use as low certainty; we downgraded two levels based
on imprecision (one small trial, wide confidence interval). The two included trials did not report on any of the primary out-
comes of this review. We did not identify any trials comparing guid-
Potential biases in the review process ed imagery with no intervention, or with another non-pharmaco-
logical method for hypertension.
The review process was conducted according to the Cochrane
Handbook for Systematic Reviews of Interventions to minimise po- Implications for research
tential bias. We performed a comprehensive search, and two au-
thors independently conducted the screening, data extraction, and Large and well-designed randomised controlled trials are needed
bias risk assessment. to evaluate the effects of guided imagery on hypertension during
pregnancy, and on other relevant short-term and long-term out-
Agreements and disagreements with other studies or comes associated with maternal and neonatal health. Trials could
reviews also consider utilisation and costs of health service.
There are very few clinical trials in which guided imagery has been ACKNOWLEDGEMENTS
used to reduce high blood pressure in pregnancy. We included only
randomised controlled trials (RCTs), excluding quasi-RCTs or cross- As part of the pre-publication editorial process, this review has
over trials. There are just two small included trials included in our been commented on by three peers (an editor and two referees who
review (and outcome data for just one of our review's secondary are external to the editorial team) and the Group's Statistical Advis-
outcomes). Consequently, there is insufficient evidence for a mean- er. The authors are grateful to the following peer reviewers for their
ingful comparison with other studies or reviews. To our knowledge, time and comments: Professor Caroline Smith, Misty Pratt.
there are no other systematic reviews looking at RCTs on guided
This project was supported by the National Institute for Health Re-
imagery for treating hypertension in pregnancy.
search, via Cochrane Infrastructure funding to Cochrane Pregnancy
The excluded study (Urech 2009) reported that guided imagery (ac- and Childbirth. The views and opinions expressed therein are those
tive versus passive relaxation) significantly improved self-report- of the authors and do not necessarily reflect those of the Systemat-
ed relaxation and was associated with a decrease in heart rate in ic Reviews Programme, NIHR, NHS or the Department of Health.
REFERENCES
References to studies included in this review ACOG 2013
Moffatt 2006 {published data only} American College of Obstetricians and Gynecologists.
Task Force on Hypertension in Pregnancy. Hypertension
* Moffatt FW, Hodnett E, Esplen MJ, Watt-Watson J. Effects
in Pregnancy. American College of Obstetricians and
of guided imagery on blood pressure in pregnant women
Gynecologists, 2013.
with hypertension: a pilot randomized controlled trial. Birth
2010;37(4):296-306. Asemi 2013
Moffatt FW, Hodnett E, Esplen MJ, Watt-Watson J. Guided Asemi Z, Tabassi Z, Samimi M, Fahiminejad T, Esmaillzadeh A.
imagery relaxation effects on blood pressure in pregnant Favourable effects of the Dietary Approaches to Stop
women with hypertension: results of a preliminary RCT. Hypertension diet on glucose tolerance and lipid profiles
Hypertension in Pregnancy 2008;27(4):514. in gestational diabetes: a randomised clinical trial. British
Journal of Nutrition 2013;109(11):2024-30. [DOI: 10.1017/
Moffatt WF. A randomized controlled trial of the effects of S0007114512004242]
guided imagery on blood pressure in hypertensive pregnant
women [thesis]. Toronto: University of Toronto, 2008. Astin 2003
Astin JA, Shapiro SL, Eisenberg DM, Forys KL. Mind-body
Moffatt WF, Hodnett E, Esplen MJ, Watt-Watson J. Satisfaction medicine: state of the science, implications for practice. Journal
and experiences of pregnant hypertensive women participating of the American Board of Family Practice 2003;16(2):131-47.
in a feasibility study of guided imagery effects on blood
pressure. Pregnancy Hypertension 2012;2(3):290. Betts 2003
Betts D. The use of acupuncture in pregnancy induced
NCT00303173. The relaxation and blood pressure in pregnancy
hypertension. Journal of Chinese Medicine 2003;71:9-13.
(REBIP) study. clinicaltrials.gov/ct2/show/NCT00303173 (first
received 15 March 2006). Brown 2000
Somers 1989 {published data only} Brown MA, Hague WM, Higgins J, Lowe S, McCowan L,
Oats J, et al. The detection, investigation and management
Somers PJ, Gevirtz RN, Jasin SE, Chin HG. The efficacy
of hypertension in pregnancy: full consensus statement.
of biobehavioral and compliance interventions in the
Australian & New Zealand Journal of Obstetrics & Gynaecology
adjunctive treatment of mild pregnancy-induced hypertension.
2000;40(2):139-55. [PUBMED: 10925900]
Biofeedback & Self Regulation 1989;14:309-18.
Brown 2001
References to studies excluded from this review Brown MA, Lindheimer MD, de Swiet M, Van Assche A,
Moutquin JM. The classification and diagnosis of the
Urech 2009 {published data only} hypertensive disorders of pregnancy: statement from the
Fink NS, Urech C, Isabel F, Meyer A, Hoesli I, Bitzer J, et al. Fetal International Society for the Study of Hypertension in
response to abbreviated relaxation techniques. A randomized Pregnancy (ISSHP). Hypertension in Pregnancy 2001;20(1):IX–
controlled study. Early Human Development 2011;87:121-7. XIV.
CHARACTERISTICS OF STUDIES
Participants 69 pregnant women with hypertension (at least 37 weeks' gestation) in 2 Canadian hospitals were
enrolled, based on the following criteria: at least 2 prenatal diastolic blood pressure readings of ≥ 90
mmHg, has had clinical investigation for hypertension, with adequate hearing acuity (for verbal and au-
diotaped instructions), and planning to give birth at 1 of the study site hospitals.
Women were excluded if diastolic blood pressure was > 110 mmHg, systolic blood pressure was > 170
mmHg, or they had significant medical conditions.
Interventions Guided imagery (N = 34): the intervention group received "a standardized 15 minutes guided imagery
with headphones at least twice daily (for 4 weeks, or until childbirth, whichever came first), with or
without an audio CD".
Quiet rest (N = 35): the control group received "a standardized verbal introduction to quiet rest and
written instructions" and was asked to "engage in quiet rest periods for 15 minutes at least twice daily
(for 4 weeks, or until childbirth, whichever came first) without external stimuli, such as reading, watch-
ing television, listening to music, or engaging in conversation".
Secondary and other outcomes: change in average daytime ambulatory systolic blood pressure or dias-
tolic blood pressure and heart rate, proportions of women who received antihypertensive medication,
anxiety, time from randomisation to delivery, relationships between blood pressure changes and fre-
quency of guided imagery use, means and standard deviations of daytime MAP after each week, com-
pliance levels, and participant satisfactions.
Notes Sources of trial funding: "The research was funded through: an Association of Women's Health, Obstet-
ric and Neonatal Nurses (AWHONN) Canada/Johnson & Johnson Canada Award, Ottawa, Ontario; the
Atlantic Region of the Association of Canadian Schools of Nursing, Antigonish, Nova Scotia; the Nursing
Research Fund, Dalhousie University, Halifax, Nova Scotia; the IWK Health Centre, Halifax, Nova Sco-
tia; and the Canadian Nurses Foundation Nursing Care Partnership, Ottawa, Ontario. During the time of
this study, Faith Wight Moffatt also received student funding from: AWHONN, Washington, DC; the Nova
Scotia Health Research Foundation, Halifax, Nova Scotia; the University of Toronto, Toronto, Ontario;
and the Canadian Institutes of Health Research Strategic Training Initiative in Research in Reproductive
Health Sciences, Ottawa, Ontario, Canada."
Trial authors' declarations of interest were not provided in the trial report.
Risk of bias
Random sequence genera- Low risk Using a computer random number generator by centralised computer "the
tion (selection bias) centralized computer randomisation service" ,,, "Blocked, using random block
sizes of six and eight".
Blinding of participants High risk Blinding of participants and personnel was not possible due to the nature of
and personnel (perfor- the intervention.
mance bias)
Moffatt 2006 (Continued)
All outcomes
Blinding of outcome as- Low risk Outcome assessors were not informed of group allocation or ambulatory
sessment (detection bias) blood pressure data.
All outcomes
Incomplete outcome data Low risk Guided imagery group 31/34 (91%), quiet rest 29/35 (83%); the number of
(attrition bias) dropouts with reasons, and balanced
All outcomes
Selective reporting (re- Low risk The trial registered in ClinicalTrials.gov, NCT00303173. All the outcomes re-
porting bias) ported in the registry reported in the papers.
Somers 1989
Methods An individual RCT
Participants Women were required to be between 30 and 36 weeks’ gestation and were recruited from “a large uni-
versity medical centre, a major US Navy hospital, and in three instances, from local obstetricians.”
The eligible criteria were as follows: MAP ≥ 95 mmHg; diastolic blood pressure ≥ 90 mmHg (or an in-
crease of 15 mmHg during the course of gestation), and systolic blood pressure increase of 30 mmHg
during the course of gestation.
Women were excluded if they had a history of essential hypertension or other blood pressure–related
disorders.
Interventions Each of the 45 participants was randomly allocated to 1 of the 3 groups: biobehavioural intervention
(guided imagery (N = 15)), bed rest alone (quiet rest (N = 15)), or compliance enhancement training (N =
15). The group of compliance enhancement training (N = 15) was excluded in this review.
Guided imagery (N = 15): the intervention group (biobehavioural) received a procedure for a total of
4 hours, involved visual imagery training, thermal biofeedback–assisted relaxation training, and self-
monitoring of blood pressure, in addition to procedures of the quiet rest (bed rest alone) and compli-
ance enhancement training groups.
Quiet rest (N = 15): the control group (bed rest alone) was prescribed bed rest and careful obstetrical
monitoring, which is standard obstetrical care for mild PIH.
Outcomes MAP ((systolic pressure - diastolic pressure)/3 + diastolic pressure) at the last prenatal visit prior to hos-
pital admission for delivery, and compliance data
Notes The following information was not provided in the trial report.
Risk of bias
Random sequence genera- Unclear risk Described as "randomly assigned" in the methods but no details available.
tion (selection bias)
Somers 1989 (Continued)
Allocation concealment Unclear risk No details described in the text
(selection bias)
Blinding of participants High risk The interventions were evident to participants and personnel.
and personnel (perfor-
mance bias)
All outcomes
Blinding of outcome as- Unclear risk No mention about outcome assessors blinding status.
sessment (detection bias)
All outcomes
Incomplete outcome data Low risk In all, 50 women were recruited, 45 (90%) of which were followed up in each
(attrition bias) group. "The 5 dropouts were evenly distributed among treatment groups and
All outcomes did not differ in blood pressure readings or demographic variables from those
women who completed the study."
Selective reporting (re- Unclear risk The protocol was not available.
porting bias)
Urech 2009 This study aimed to compare the immediate effects of 2 active and 1 passive 10-minute relaxation
technique on perceived and physiological indicators of relaxation. The study population was out of
our scope and included only healthy women; women with pregnancy-induced hypertension, pre-
eclampsia, or both, were excluded.
DATA AND ANALYSES
Comparison 1. Guided imagery versus quiet rest
Outcome or subgroup title No. of No. of partici- Statistical method Effect size
studies pants
1 Antihypertensive drug use 1 69 Risk Ratio (M-H, Fixed, 95% CI) 1.27 [0.72, 2.22]
Analysis 1.1. Comparison 1 Guided imagery versus quiet rest, Outcome 1 Antihypertensive drug use.
Study or subgroup Guided imagery Quiet rest Risk Ratio Weight Risk Ratio
n/N n/N M-H, Fixed, 95% CI M-H, Fixed, 95% CI
Moffatt 2006 16/34 13/35 100% 1.27[0.72,2.22]
Total (95% CI) 34 35 100% 1.27[0.72,2.22]
Total events: 16 (Guided imagery), 13 (Quiet rest)
Heterogeneity: Tau2=0; Chi2=0, df=0(P<0.0001); I2=100%
Test for overall effect: Z=0.83(P=0.41)
APPENDICES
ICTRP
CONTRIBUTIONS OF AUTHORS
Megumi Haruna (MH), Masayo Matsuzaki (MM), and Erika Ota (EO) drafted the review, with support from Mie Shiraishi (MS), Nobutsugu
Hanada (NH), and Rintaro Mori (RM).
MM, MS, NH, EO, and RM provided comments. All authors read and approved the final manuscript.
DECLARATIONS OF INTEREST
Megumi Haruna: none known.
DIFFERENCES BETWEEN PROTOCOL AND REVIEW
The are some differences between this review and the published protocol for this review (Haruna 2014).
We added a search of ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) for unpublished, planned and
ongoing trial reports.
We updated our methods to include the use of GRADE to assess the certainty of the evidence, and presented the results in a 'Summary
of findings' table.
The methods in the protocol could not be applied because of a lack of all primary and many secondary outcome data.
INDEX TERMS