HypertensionNCT00303173
The Relaxation and Blood Pressure in Pregnancy (REBIP) Study
A study testing Guided Imagery in people with Hypertension and Hypertension, Pregnancy-Induced, run by University of Toronto at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hypertension, Hypertension, Pregnancy-Induced, Pre-Eclampsia
- What is being tested?
- Guided Imagery
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 69 participants
- Where
- 2 sitesCanada
- Study dates
- Aug 2004to Feb 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
Womens Health Centre, Eastern Health
St. John's, Newfoundland and Labrador, A1B 3V6
About this 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
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.
- Conditions
- Hypertension, Hypertension, Pregnancy-Induced, Pre-Eclampsia
- Being tested
- Guided Imagery
- Keywords
- Pre-eclampsia, hypertension, blood pressure, pregnancy, randomized clinical trial, guided imagery, relaxation, psychophysiology, mind-body
- Medical subject headings
- Hypertension, Hypertension, Pregnancy-Induced, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided ImageryBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Daytime ambulatory mean arterial pressure
Measured: 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
Measured: 4 weeks post-randomization (or if delivery is sooner, at most recent ambulatory BP monitoring session
Antihypertensive medication use after randomization
Measured: between randomization and end of postpartum hospitalization
Maternal anxiety
Measured: 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
Relationship between classification of hypertension and effectiveness of guided imagery
Relationship between participants' evaluations of their imagery experiences and effectiveness of guided imagery
Measured: At 4 weeks post-randomization (or if delivery is sooner, at most recent week od available data)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2006 (estimated)
- Study startAug 2004
- Primary completionDec 2006
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Dalhousie University, AWHONN Canada, with Canadian Nurses Foundation Nursing Care Partnership, IWK Health Centre with Canadian Nurses Foundation Nursing Care Partnership
- Investigators
- C. Faith Wight Moffatt, MS, PhD (c), Principal investigator, University of Toronto, Dalhousie UniversityEllen Hodnett, PhD, Study chair, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00303173
- Sponsor's protocol ID
- 16081
- Status last verified
- Jun 2008
- First submitted
- 14 Mar 2006
- Last updated
- 25 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00303173
- Acronym / sponsor ID
- 16081
- Conditions
- Hypertension, Hypertension, Pregnancy-Induced, Pre-Eclampsia
- Keywords
- Pre-eclampsia, hypertension, blood pressure, pregnancy, randomized clinical trial, guided imagery, relaxation, psychophysiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Dalhousie University, AWHONN Canada, with Canadian Nurses Foundation Nursing Care Partnership, IWK Health Centre with Canadian Nurses Foundation Nursing Care Partnership
- Study start
- Aug 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 15 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided Imagery | Behavioural | – |
Primary outcome
Daytime ambulatory mean arterial pressure
Time frame: 4 weeks post-randomization (or if delivery is sooner, at most recent ambulatory BP monitoring session
7 secondary outcomes
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
Antihypertensive medication use after randomization
Time frame: between randomization and end of postpartum hospitalization
Maternal anxiety
Time frame: 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
Relationship between classification of hypertension and effectiveness of guided imagery
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
C. Faith Wight Moffatt, MS, PhD (c) principal investigator
University of Toronto, Dalhousie University
Ellen Hodnett, PhD study chair
University of Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Imagery in people with Hypertension and Hypertension, Pregnancy-Induced, run by University of Toronto at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daytime ambulatory mean arterial pressure (time frame: 4 weeks post-randomization (or if delivery is sooner, at most recent ambulatory BP monitoring session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2008.