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

Study Overview
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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.

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.

Official Title
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Phase 3 Study of Modified Relaxation (MR) Technique for Treating Hypertension in Postmenopausal Women

Conditions
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Postmenopausal Syndrome, Hypertension

Intervention / Treatment
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* Behavioral: Modified Relaxation (MR)
* Behavioral: Lifestyle Education (LE)


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Lifestyle Education (LE)<br>Lifestyle Education (LE) Participants in this group will receive conventional care and lifestyle education on dietary choice and exercise. | Behavioral: Lifestyle Education (LE)<br>* Participants in this group will receive conventional care and lifestyle education on dietary choice and exercise.<br>* Other names: Lifestyle Modification;|
| Experimental: Modified Relaxation (MR)<br>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. | Behavioral: Modified Relaxation (MR)<br>* 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.<br>* Other names: Behavioral Relaxation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in SBP. | Measure the systolic blood pressure (SBP) after intervention at 1, 2 ,3 , and 4 months. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in DBP. | Measure the diastolic blood pressure (DBP) after intervention at 1, 2 ,3 , and 4 months. | 16 weeks | 
| Continuation rate of MR practice. | Measure the continuation rate of MR practice after 4 months of follow-up period. | 16 weeks | 
| Drop-out rates. | Measure the drop-out rate after intervention at 1, 2, 3, and 4 months of follow-up period. | 16 weeks | 
| Numbers of subjects who require anti-hypertensive medication. | Measure the numbers of subjects who require anti-hypertensive medication after intervention 4 months of follow-up period. | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postmenopause, hypertension, relaxation, SBP 140-159 mmHg, DBP 90-99 mmHg, stage 1 or mild hypertension