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Completed

NCT Number: NCT00303173

The Relaxation and Blood Pressure in Pregnancy (REBIP) 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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases Vascular Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Womens Health Centre, Eastern Health, St. John's, Newfoundland and Labrador, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GUIDED IMAGERY

Behavioral

Primary outcomes

  1. Daytime ambulatory mean arterial pressure

    Time frame: 4 weeks post-randomization (or if delivery is sooner, at most recent ambulatory BP monitoring session

Secondary outcomes

  1. 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

  2. Antihypertensive medication use after randomization

    Time frame: between randomization and end of postpartum hospitalization

  3. Maternal anxiety

    Time frame: 4 weeks post-randomization (or if delivery is sooner, at most recent week of available data.

  4. Time to delivery

  5. Relationship of blood pressure changes to reported frequency of guided imagery undertaken

  6. Relationship between classification of hypertension and effectiveness of guided imagery

  7. 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)

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • AWHONN Canada, with Canadian Nurses Foundation Nursing Care Partnership
  • Dalhousie University
  • IWK Health Centre with Canadian Nurses Foundation Nursing Care Partnership

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2006
Study completion
2007
First posted
Mar 15, 2006
Registry last updated
Jun 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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