Clinical trial NCT01429662: Modified Relaxation (MR) Technique for Treating Hypertension in Postmenopausal Women
Official title: Phase 3 Study of Modified Relaxation (MR) Technique for Treating Hypertension in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postmenopausal Syndrome
Hypertension
Keywords: postmenopause
hypertension
relaxation
SBP 140-159 mmHg
DBP 90-99 mmHg
stage 1 or mild hypertension
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2011-09-07
Enrollment: 429
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in SBP.
timeFrame: 16 weeks
Secondary outcomes:
measure: Changes in DBP.
timeFrame: 16 weeks
measure: Continuation rate of MR practice.
timeFrame: 16 weeks
measure: Drop-out rates.
timeFrame: 16 weeks
measure: Numbers of subjects who require anti-hypertensive medication.
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Maha Sarakham
country: Thailand
facility: Mahasarakham Hospital
state: Northeast
Study officials:
affiliation: PhD in Clinical Epidemiology Program, Faculty of Medicine, Chiang Mai University (Thailand)
name: Suprawita Saensak, PhDcandidate
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saensak S, Vutyavanich T, Somboonporn W, Srisurapanont M. Modified relaxation technique for treating hypertension in Thai postmenopausal women. J Multidiscip Healthc. 2013 Oct 3;6:373-8. doi: 10.2147/JMDH.S51580. eCollection 2013.