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The Relaxation and Blood Pressure in Pregnancy (REBIP) Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00303173
First Posted: March 15, 2006
Last Update Posted: June 25, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]

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 ]
  • Antihypertensive medication use after randomization [ Time Frame: 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. ]
  • 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 [ Time Frame: At 4 weeks post-randomization (or if delivery is sooner, at most recent week od available data) ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Faith Wight Moffatt, University of Toronto
ClinicalTrials.gov Identifier: NCT00303173     History of Changes
Other Study ID Numbers: 16081
First Submitted: March 14, 2006
First Posted: March 15, 2006
Last Update Posted: June 25, 2008
Last Verified: June 2008

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:
Hypertension
Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications