The Relaxation and Blood Pressure in Pregnancy (REBIP) Study

June 23, 2008 updated by: University of Toronto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Womens Health Centre, Eastern Health
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • IWK Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to delivery
Daytime ambulatory systolic and diastolic blood pressure, and heart rate
Time Frame: 4 weeks post-randomization (or if delivery is sooner, at most recent ambulatory BP monitoring session
4 weeks post-randomization (or if delivery is sooner, at most recent ambulatory BP monitoring session
Antihypertensive medication use after randomization
Time Frame: between randomization and end of postpartum hospitalization
between randomization and end of postpartum hospitalization
Maternal anxiety
Time Frame: 4 weeks post-randomization (or if delivery is sooner, at most recent week of available data.
4 weeks post-randomization (or if delivery is sooner, at most recent week of available data.
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
Time Frame: At 4 weeks post-randomization (or if delivery is sooner, at most recent week od available data)
At 4 weeks post-randomization (or if delivery is sooner, at most recent week od available data)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Collaborators

Dalhousie University
AWHONN Canada, with Canadian Nurses Foundation Nursing Care Partnership
IWK Health Centre with Canadian Nurses Foundation Nursing Care Partnership

Investigators

  • Principal Investigator: C. Faith Wight Moffatt, MS, PhD (c), University of Toronto, Dalhousie University
  • Study Chair: Ellen Hodnett, PhD, University of Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

March 14, 2006

First Submitted That Met QC Criteria

March 14, 2006

First Posted (Estimate)

March 15, 2006

Study Record Updates

Last Update Posted (Estimate)

June 25, 2008

Last Update Submitted That Met QC Criteria

June 23, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16081

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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