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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 |
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Information provided by: | University of Toronto |
ClinicalTrials.gov Identifier: | NCT00303173 |
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 |
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Hypertension Hypertension, Pregnancy-Induced Pre-Eclampsia |
Behavioral: Guided Imagery |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy 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 |
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) |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | C. Faith Wight Moffatt, MS, PhD (c) | University of Toronto, Dalhousie University |
Study Chair: | Ellen Hodnett, PhD | University of Toronto |
Responsible Party: | University of Toronto ( Faith Wight Moffatt ) |
Study ID Numbers: | 16081 |
Study First Received: | March 14, 2006 |
Last Updated: | June 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00303173 History of Changes |
Health Authority: | Canada: Ethics Review Committee |
Pre-eclampsia hypertension blood pressure pregnancy randomized clinical trial |
guided imagery relaxation psychophysiology mind-body |
Hypertension, Pregnancy-Induced Pregnancy Complications Eclampsia Vascular Diseases |
Pre-Eclampsia Preeclampsia Hypertension |
Hypertension, Pregnancy-Induced Pregnancy Complications Eclampsia Vascular Diseases |
Pre-Eclampsia Cardiovascular Diseases Hypertension |