The Relaxation and Blood Pressure in Pregnancy (REBIP) Study

Study Overview
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Brief Summary
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Over 10% of women have high blood pressure during their pregnancy which may affect their health or that of their baby. There are currently no methods to prevent most high blood pressure in pregnancy and some treatments are not desirable for use in pregnancy. Previous research indicates that simple relaxation methods can reduce blood pressure and anxiety levels for some people, but this has not been well-studied, especially during pregnancy. This pilot study is intended to determine how guided imagery (imagining relaxing scenes) affects blood pressure and anxiety, and to assess how satisfied women are with this technique. Sixty-six pregnant women with high blood pressure will be randomly assigned to (1) listen to a guided imagery audio-compact disc or (2) quiet rest, at least twice-daily for 4 weeks. All women in both groups will receive all usual care, plus will have their blood pressure measured regularly during 1 day per week for 4 weeks. This study will determine if imagery lowers maternal blood pressure, and if further research on imagery effects on pregnancy health outcomes is feasible.

Official Title
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A Randomized Controlled Trial of The Effectiveness of Guided Imagery on Blood Pressure in Hypertensive Pregnant Women: The Relaxation and Blood Pressure in Pregnancy (REBIP) Pilot Study

Conditions
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Hypertension, Hypertension, Pregnancy-Induced, Pre-Eclampsia

Intervention / Treatment
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* Behavioral: Guided Imagery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant, and less than or equal to (<) 36 weeks, 6 days gestation At least two prenatal blood pressure readings > 90 mmHg diastolic Has had clinical investigation of the hypertension Hearing acuity adequate to hear verbal and audiotaped instructions Planning to give birth at one of the study site health centres Competent to give informed consent Exclusion Criteria: Likely to deliver within 10 days (including women with diastolic BP >110 mmHg, or systolic BP >170 mmHg; unstable diabetes, concurrent antepartum hemorrhage, preterm labour, and/or other significant medical) Prescribed antihypertensive medication at baseline Documented psychotic illness Unable to understand and read English
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Guided Imagery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daytime ambulatory mean arterial pressure |  | 4 weeks post-randomization (or if delivery is sooner, at most recent ambulatory BP monitoring session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daytime ambulatory systolic and diastolic blood pressure, and heart rate |  | 4 weeks post-randomization (or if delivery is sooner, at most recent ambulatory BP monitoring session | 
| Antihypertensive medication use after randomization |  | between randomization and end of postpartum hospitalization | 
| Maternal anxiety |  | 4 weeks post-randomization (or if delivery is sooner, at most recent week of available data. | 
| Time to delivery |  |  | 
| Relationship of blood pressure changes to reported frequency of guided imagery undertaken |  |  | 
| Relationship between classification of hypertension and effectiveness of guided imagery |  |  | 
| Relationship between participants' evaluations of their imagery experiences and effectiveness of guided imagery |  | At 4 weeks post-randomization (or if delivery is sooner, at most recent week od available data) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, Pre-eclampsia, blood pressure, pregnancy, randomized clinical trial, guided imagery, relaxation, psychophysiology, mind-body