Clinical trial NCT00303173: The Relaxation and Blood Pressure in Pregnancy (REBIP) Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Hypertension, Pregnancy-Induced
Pre-Eclampsia
Keywords: Pre-eclampsia
hypertension
blood pressure
pregnancy
randomized clinical trial
guided imagery
relaxation
psychophysiology
mind-body
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Dalhousie University
name: AWHONN Canada, with Canadian Nurses Foundation Nursing Care Partnership
name: IWK Health Centre with Canadian Nurses Foundation Nursing Care Partnership
First posted: 2006-03-15
Enrollment: 69
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Daytime ambulatory mean arterial pressure
timeFrame: 4 weeks post-randomization (or if delivery is sooner, at most recent ambulatory BP monitoring session
Secondary outcomes:
measure: Daytime ambulatory systolic and diastolic blood pressure, and heart rate
timeFrame: 4 weeks post-randomization (or if delivery is sooner, at most recent ambulatory BP monitoring session
measure: Antihypertensive medication use after randomization
timeFrame: between randomization and end of postpartum hospitalization
measure: Maternal anxiety
timeFrame: 4 weeks post-randomization (or if delivery is sooner, at most recent week of available data.
measure: Time to delivery
measure: Relationship of blood pressure changes to reported frequency of guided imagery undertaken
measure: Relationship between classification of hypertension and effectiveness of guided imagery
measure: Relationship between participants' evaluations of their imagery experiences and effectiveness of guided imagery
timeFrame: At 4 weeks post-randomization (or if delivery is sooner, at most recent week od available data)
Other outcomes:
Locations:
city: St. John's
country: Canada
facility: Womens Health Centre, Eastern Health
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
affiliation: University of Toronto, Dalhousie University
name: C. Faith Wight Moffatt, MS, PhD (c)
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Ellen Hodnett, PhD
role: STUDY_CHAIR
References: