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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Suprawita Saensak, Chiang Mai University
ClinicalTrials.gov Identifier:
NCT01429662
First received: September 3, 2011
Last updated: May 27, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Postmenopausal Syndrome
Hypertension
Behavioral: Modified Relaxation (MR)
Behavioral: Lifestyle Education (LE)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3 Study of Modified Relaxation (MR) Technique for Treating Hypertension in Postmenopausal Women

Resource links provided by NLM:


Further study details as provided by Chiang Mai University:

Primary Outcome Measures:
  • Changes in SBP. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Measure the systolic blood pressure (SBP) after intervention at 1, 2 ,3 , and 4 months.


Secondary Outcome Measures:
  • Changes in DBP. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Measure the diastolic blood pressure (DBP) after intervention at 1, 2 ,3 , and 4 months.

  • Continuation rate of MR practice. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Measure the continuation rate of MR practice after 4 months of follow-up period.

  • Drop-out rates. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Measure the numbers of subjects who require anti-hypertensive medication after intervention 4 months of follow-up period.


Enrollment: 429
Study Start Date: August 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Lifestyle Education (LE)
Lifestyle Education (LE) Participants in this group will receive conventional care and lifestyle education on dietary choice and exercise.
Behavioral: Lifestyle Education (LE)
Participants in this group will receive conventional care and lifestyle education on dietary choice and exercise.
Other Name: Lifestyle Modification
Experimental: 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: 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.
Other Name: Behavioral Relaxation

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

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01429662

Locations
Thailand
Mahasarakham Hospital
Maha Sarakham, Northeast, Thailand, 44000
Sponsors and Collaborators
Chiang Mai University
Investigators
Principal Investigator: Suprawita Saensak, PhDcandidate PhD in Clinical Epidemiology Program, Faculty of Medicine, Chiang Mai University (Thailand)
  More Information

Additional Information:
No publications provided

Responsible Party: Suprawita Saensak, PhD candidate (Clinical Epidemiology), Chiang Mai University
ClinicalTrials.gov Identifier: NCT01429662     History of Changes
Other Study ID Numbers: MRLE-HTN
Study First Received: September 3, 2011
Last Updated: May 27, 2012
Health Authority: Thailand: Ministry of Public Health

Keywords provided by Chiang Mai University:
postmenopause
hypertension
relaxation
SBP 140-159 mmHg
DBP 90-99 mmHg
stage 1 or mild hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 31, 2014