A Phase 3 interventional study of Modified Relaxation (MR) and Lifestyle Education (LE) in Postmenopausal Syndrome and Hypertension, sponsored by Chiang Mai University. Completed at 1 site in Thailand. Open to female participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-05-30.
Sponsored by Chiang Mai University · Phase 3, Interventional, and Treatment
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.
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.
6,689 studies on the registry are indexed under Hypertension; 964 are open to participants now.
This study's enrollment of 429 is above the median of 90 across 4,994 interventional studies indexed under Hypertension.
Browse Hypertension studies →Chiang Mai University is the lead sponsor of 116 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Lifestyle Education (LE) Participants in this group will receive conventional care and lifestyle education on dietary choice and exercise.
Behavioral: Lifestyle Education (LE)
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)
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.
Also known as: Behavioral Relaxation
Participants in this group will receive conventional care and lifestyle education on dietary choice and exercise.
Also known as: Lifestyle Modification
Changes in SBP.
Measure the systolic blood pressure (SBP) after intervention at 1, 2 ,3 , and 4 months.
Time frame: 16 weeks
Changes in DBP.
Measure the diastolic blood pressure (DBP) after intervention at 1, 2 ,3 , and 4 months.
Time frame: 16 weeks
Continuation rate of MR practice.
Measure the continuation rate of MR practice after 4 months of follow-up period.
Time frame: 16 weeks
Drop-out rates.
Measure the drop-out rate after intervention at 1, 2, 3, and 4 months of follow-up period.
Time frame: 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.
Time frame: 16 weeks
This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chiang Mai University