The Relaxation and Blood Pressure in Pregnancy (REBIP) Study

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00303173
• Other study ID #: 16081
• Status: Completed
• Phase: N/A
• First received: March 14, 2006
• Last updated: June 23, 2008
• Start date: August 2004
• Est. completion date: February 2007

Study information

• Verified date: June 2008
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: February 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Eclampsia
• Hypertension
• Hypertension, Pregnancy-Induced
• Pre-Eclampsia

Intervention

Behavioral:
• Guided Imagery

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax	Nova Scotia
Canada	Womens Health Centre, Eastern Health	St. John's	Newfoundland and Labrador

Sponsors (4)

Lead Sponsor	Collaborator
University of Toronto	AWHONN Canada, with Canadian Nurses Foundation Nursing Care Partnership, Dalhousie University, IWK Health Centre with Canadian Nurses Foundation Nursing Care Partnership

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daytime ambulatory mean arterial pressure		4 weeks post-randomization (or if delivery is sooner, at most recent ambulatory BP monitoring session	No
Secondary	Daytime ambulatory systolic and diastolic blood pressure, and heart rate		4 weeks post-randomization (or if delivery is sooner, at most recent ambulatory BP monitoring session	No
Secondary	Antihypertensive medication use after randomization		between randomization and end of postpartum hospitalization	No
Secondary	Maternal anxiety		4 weeks post-randomization (or if delivery is sooner, at most recent week of available data.	No
Secondary	Time to delivery			No
Secondary	Relationship of blood pressure changes to reported frequency of guided imagery undertaken			No
Secondary	Relationship between classification of hypertension and effectiveness of guided imagery			No
Secondary	Relationship between participants' evaluations of their imagery experiences and effectiveness of guided imagery		At 4 weeks post-randomization (or if delivery is sooner, at most recent week od available data)	No