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The Relaxation and Blood Pressure in Pregnancy (REBIP) Study

NCT ID: NCT00303173

Last Updated: 2008-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2007-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension Hypertension, Pregnancy-Induced Pre-Eclampsia

Keywords

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Pre-eclampsia hypertension blood pressure pregnancy randomized clinical trial guided imagery relaxation psychophysiology mind-body

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Guided Imagery

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Dalhousie University

OTHER

Sponsor Role collaborator

AWHONN Canada, with Canadian Nurses Foundation Nursing Care Partnership

UNKNOWN

Sponsor Role collaborator

IWK Health Centre with Canadian Nurses Foundation Nursing Care Partnership

UNKNOWN

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role lead

Responsible Party

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University of Toronto

Principal Investigators

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C. Faith Wight Moffatt, MS, PhD (c)

Role: PRINCIPAL_INVESTIGATOR

University of Toronto, Dalhousie University

Ellen Hodnett, PhD

Role: STUDY_CHAIR

University of Toronto

Locations

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Womens Health Centre, Eastern Health

St. John's, Newfoundland and Labrador, Canada

Site Status

IWK Health Centre

Halifax, Nova Scotia, Canada

Site Status

Countries

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Canada

Other Identifiers

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16081

Identifier Type: -

Identifier Source: org_study_id