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The Relaxation and Blood Pressure in Pregnancy (REBIP) Study

Primary Purpose

Hypertension, Hypertension, Pregnancy-Induced, Pre-Eclampsia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Guided Imagery
Sponsored by
University of Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Pre-eclampsia, hypertension, blood pressure, pregnancy, randomized clinical trial, guided imagery, relaxation, psychophysiology, mind-body

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Womens Health Centre, Eastern Health
  • IWK Health Centre

Outcomes

Primary Outcome Measures

Daytime ambulatory mean arterial pressure

Secondary Outcome Measures

Daytime ambulatory systolic and diastolic blood pressure, and heart rate
Antihypertensive medication use after randomization
Maternal anxiety
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

Full Information

First Posted
March 14, 2006
Last Updated
June 23, 2008
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
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1. Study Identification

Unique Protocol Identification Number
NCT00303173
Brief Title
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

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the 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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Hypertension, Pregnancy-Induced, Pre-Eclampsia
Keywords
Pre-eclampsia, hypertension, blood pressure, pregnancy, randomized clinical trial, guided imagery, relaxation, psychophysiology, mind-body

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Guided Imagery
Primary Outcome Measure Information:
Title
Daytime ambulatory mean arterial pressure
Time Frame
4 weeks post-randomization (or if delivery is sooner, at most recent ambulatory BP monitoring session
Secondary Outcome Measure Information:
Title
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
Title
Antihypertensive medication use after randomization
Time Frame
between randomization and end of postpartum hospitalization
Title
Maternal anxiety
Time Frame
4 weeks post-randomization (or if delivery is sooner, at most recent week of available data.
Title
Time to delivery
Title
Relationship of blood pressure changes to reported frequency of guided imagery undertaken
Title
Relationship between classification of hypertension and effectiveness of guided imagery
Title
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)

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C. Faith Wight Moffatt, MS, PhD (c)
Organizational Affiliation
University of Toronto, Dalhousie University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ellen Hodnett, PhD
Organizational Affiliation
University of Toronto
Official's Role
Study Chair
Facility Information:
Facility Name
Womens Health Centre, Eastern Health
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada

12. IPD Sharing Statement

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The Relaxation and Blood Pressure in Pregnancy (REBIP) Study

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