NCT00303173

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Aug 2004

Typical duration for not_applicable hypertension

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

June 25, 2008

Status Verified

June 1, 2008

Enrollment Period

2.3 years

First QC Date

March 14, 2006

Last Update Submit

June 23, 2008

Conditions

HypertensionHypertension, Pregnancy-InducedPre-Eclampsia

Keywords

Pre-eclampsiahypertensionblood pressurepregnancyrandomized clinical trialguided imageryrelaxationpsychophysiologymind-body

Outcome Measures

Primary Outcomes (1)

  • Daytime ambulatory mean arterial pressure

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

Secondary Outcomes (7)

  • 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

  • Antihypertensive medication use after randomization

    between randomization and end of postpartum hospitalization

  • Maternal anxiety

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

  • Time to delivery

  • Relationship of blood pressure changes to reported frequency of guided imagery undertaken

  • +2 more secondary outcomes

Interventions

Guided ImageryBEHAVIORAL

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Womens Health Centre, Eastern Health

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

MeSH Terms

Conditions

HypertensionHypertension, Pregnancy-InducedPre-Eclampsia

Interventions

Imagery, Psychotherapy

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

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

    University of Toronto, Dalhousie University

    PRINCIPAL INVESTIGATOR

  • Ellen Hodnett, PhD

    University of Toronto

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 14, 2006

First Posted

March 15, 2006

Study Start

August 1, 2004

Primary Completion

December 1, 2006

Study Completion

February 1, 2007

Last Updated

June 25, 2008

Record last verified: 2008-06

Locations

CA(2)