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Completed

NCT Number: NCT01429662

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

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.

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Key information

Conditions

Postmenopausal Syndrome Cardiovascular Diseases Hypertension Vascular Diseases

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Mahasarakham Hospital

Maha Sarakham, Northeast, 44000, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Modified Relaxation (MR)

Behavioral

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.

Other names: Behavioral Relaxation

Lifestyle Education (LE)

Behavioral

Participants in this group will receive conventional care and lifestyle education on dietary choice and exercise.

Other names: Lifestyle Modification

Primary outcomes

  1. Changes in SBP.

    Time frame: 16 weeks

    Measure the systolic blood pressure (SBP) after intervention at 1, 2 ,3 , and 4 months.

Secondary outcomes

  1. Changes in DBP.

    Time frame: 16 weeks

    Measure the diastolic blood pressure (DBP) after intervention at 1, 2 ,3 , and 4 months.

  2. Continuation rate of MR practice.

    Time frame: 16 weeks

    Measure the continuation rate of MR practice after 4 months of follow-up period.

  3. Drop-out rates.

    Time frame: 16 weeks

    Measure the drop-out rate after intervention at 1, 2, 3, and 4 months of follow-up period.

  4. Numbers of subjects who require anti-hypertensive medication.

    Time frame: 16 weeks

    Measure the numbers of subjects who require anti-hypertensive medication after intervention 4 months of follow-up period.

Sponsors and collaborators

Lead sponsor

Chiang Mai University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 7, 2011
Registry last updated
May 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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