NCT01429662

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 429 (actual)
• Sponsor: Chiang Mai University · Academic / Other
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postmenopausal Syndrome
• Hypertension

Interventions

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

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2011-09-07
• Last updated: 2012-05-30

Locations

1 site across 1 country: Thailand