Modified Relaxation (MR) Technique for Treating Hypertension in Postmenopausal Women

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

PHASE3

Total Enrollment

429 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-03-31

Brief Summary

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The purpose of this study is to demonstrate better effectiveness of modified relaxation (MR) technique over no MR for treating hypertension in Thai postmenopausal women.

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Detailed Description

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Medical treatment of hypertension (HTN) in postmenopausal women is not very effective, as it requires co-operation and long-term commitment from the patients and their families. The medication itself may cause bothersome side effects and it can pose economic burden to the patients and the society. In contrast, lifestyle modifications, particularly relaxation technique, are less costly and relatively free of any side effects. Once the patients master the techniques, they can practice by themselves at home and at any time that is convenient to them. There is evidence from at least one RCT that the techniques are effective in reducing the systolic blood pressure (SBP) and diastolic blood pressure (DBP), even after a short practice of only two months.

In this study, the investigators propose a randomized control trial to examine the effectiveness of modified relaxation (MR) technique to control HTN in Thai postmenopausal women against a control group who practice no MR. Such a study in Thai population has not been done before. In addition, the investigators will extend the period of observation up to 16 weeks, to assess longer-term patients' compliance, and the effects of MR on BP.

Conditions

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Postmenopausal Syndrome Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lifestyle Education (LE)

Lifestyle Education (LE) Participants in this group will receive conventional care and lifestyle education on dietary choice and exercise.

Group Type SHAM_COMPARATOR

Lifestyle Education (LE)

Intervention Type BEHAVIORAL

Participants in this group will receive conventional care and lifestyle education on dietary choice and exercise.

Modified Relaxation (MR)

Modified Relaxation (MR) This technique intend to train participants in a group of 8-10 in only 1 session that lasts 60 minutes. After completing the training, participants will be given a hand-out on MR. They will be asked to practice MR at home once a day for 15-20 minutes during their leisure times, for at least 5 days a week during the whole 16 weeks of the study period.

Group Type EXPERIMENTAL

Modified Relaxation (MR)

Intervention Type BEHAVIORAL

Modified Relaxation (MR) This technique intend to train participants in a group of 8-10 in only 1 session that lasts 60 minutes. After completing the training, participants will be given a hand-out on MR. They will be asked to practice MR at home once a day for 15-20 minutes during their leisure times, for at least 5 days a week during the whole 16 weeks of the study period.

Interventions

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Modified Relaxation (MR)

Modified Relaxation (MR) This technique intend to train participants in a group of 8-10 in only 1 session that lasts 60 minutes. After completing the training, participants will be given a hand-out on MR. They will be asked to practice MR at home once a day for 15-20 minutes during their leisure times, for at least 5 days a week during the whole 16 weeks of the study period.

Intervention Type BEHAVIORAL

Lifestyle Education (LE)

Participants in this group will receive conventional care and lifestyle education on dietary choice and exercise.

Intervention Type BEHAVIORAL

Other Intervention Names

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Behavioral Relaxation Lifestyle Modification

Eligibility Criteria

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Inclusion Criteria

* Stage 1 essential hypertension, defined as a systolic blood pressure of 140-159 and/or DBP of 90-99 mmHg on two occasions at least 30 minutes apart.
* Women who are able to attend follow visits as advised.

Exclusion Criteria

* Women with systolic blood pressure (SBP) \>160 mmHg or diastolic blood pressure (DBP) \>100 mmHg.
* Women who have other known causes of hypertension, such as renal diseases
* Women who are using sedatives or tranquilizer,or antidepressant, or antihypertensive medication during the past 2 months prior to the study.
* Have language or geographical barrier.
* Do not give their informed consent.
* Women who need to be prescribed HRT.

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No