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

March 14, 2006
June 23, 2008
August 2004
December 2006   (final data collection date for primary outcome measure)
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 ]
Daytime ambulatory mean arterial pressure after 4 weeks (or if delivery is sooner, at most recent ambulatory BP monitoring session)
Complete list of historical versions of study NCT00303173 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Daytime ambulatory mean arterial, systolic and diastolic blood pressure, and heart rate at 1, 2, 3 and 4 weeks of study condition.
  • 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
Not Provided
Not Provided
 
The Relaxation and Blood Pressure in Pregnancy (REBIP) Study
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hypertension
  • Hypertension, Pregnancy-Induced
  • Pre-Eclampsia
Behavioral: Guided Imagery
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
69
February 2007
December 2006   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00303173
16081
No
Faith Wight Moffatt, University of Toronto
University of Toronto
  • Dalhousie University
  • AWHONN Canada, with Canadian Nurses Foundation Nursing Care Partnership
  • IWK Health Centre with Canadian Nurses Foundation Nursing Care Partnership
Principal Investigator: C. Faith Wight Moffatt, MS, PhD (c) University of Toronto, Dalhousie University
Study Chair: Ellen Hodnett, PhD University of Toronto
University of Toronto
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP