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

Phase 3

Completed

• Conditions: Postmenopausal Syndrome; Hypertension

• Registration Number: NCT01429662
• Lead Sponsor: Chiang Mai University

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-09-03
• Study First Submitted QC: 2011-09-06
• Study First Posted: 2011-09-07
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-27
• Last Update Posted: 2012-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 429

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in SBP.	16 weeks	Measure the systolic blood pressure (SBP) after intervention at 1, 2 ,3 , and 4 months.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mahasarakham Hospital; 🇹🇭 Maha Sarakham, Northeast, Thailand