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The Relaxation and Blood Pressure in Pregnancy (REBIP) Study

This study has been completed.
Sponsor:
Collaborators:
Dalhousie University
AWHONN Canada, with Canadian Nurses Foundation Nursing Care Partnership
IWK Health Centre with Canadian Nurses Foundation Nursing Care Partnership
Information provided by:
University of Toronto
ClinicalTrials.gov Identifier:
NCT00303173
First received: March 14, 2006
Last updated: June 23, 2008
Last verified: June 2008
History of Changes
  Purpose

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.


Condition Intervention
Hypertension
Hypertension, Pregnancy-Induced
Pre-Eclampsia
 Behavioral: Guided Imagery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Daytime ambulatory mean arterial pressure [ Time Frame: 4 weeks post-randomization (or if delivery is sooner, at most recent ambulatory BP monitoring session ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Antihypertensive medication use after randomization [ Time Frame: between randomization and end of postpartum hospitalization ] [ Designated as safety issue: No ]
  • Maternal anxiety [ Time Frame: 4 weeks post-randomization (or if delivery is sooner, at most recent week of available data. ] [ Designated as safety issue: No ]
  • Time to delivery [ Designated as safety issue: No ]
  • Relationship of blood pressure changes to reported frequency of guided imagery undertaken [ Designated as safety issue: No ]
  • Relationship between classification of hypertension and effectiveness of guided imagery [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 69
Study Start Date: August 2004
Study Completion Date: February 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00303173

Locations
Canada, Newfoundland and Labrador
Womens Health Centre, Eastern Health
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Sponsors and Collaborators
University of Toronto
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
  More Information

No publications provided

Responsible Party: Faith Wight Moffatt, University of Toronto
ClinicalTrials.gov Identifier: NCT00303173     History of Changes
Other Study ID Numbers: 16081
Study First Received: March 14, 2006
Last Updated: June 23, 2008
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Toronto:
Pre-eclampsia
hypertension
blood pressure
pregnancy
randomized clinical trial
 guided imagery
relaxation
psychophysiology
mind-body

Additional relevant MeSH terms:
Eclampsia
Hypertension
Pre-Eclampsia
Hypertension, Pregnancy-Induced
 Pregnancy Complications
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013