We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01429662
Recruitment Status : Completed
First Posted : September 7, 2011
Last Update Posted : May 30, 2012
Sponsor:
Information provided by (Responsible Party):

September 3, 2011
September 7, 2011
May 30, 2012
August 2011
March 2012   (Final data collection date for primary outcome measure)
Changes in SBP. [ Time Frame: 16 weeks ]
Measure the systolic blood pressure (SBP) after intervention at 1, 2 ,3 , and 4 months.
Same as current
Complete list of historical versions of study NCT01429662 on ClinicalTrials.gov Archive Site
  • Changes in DBP. [ Time Frame: 16 weeks ]
    Measure the diastolic blood pressure (DBP) after intervention at 1, 2 ,3 , and 4 months.
  • Continuation rate of MR practice. [ Time Frame: 16 weeks ]
    Measure the continuation rate of MR practice after 4 months of follow-up period.
  • 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.
  • 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.
Same as current
Not Provided
Not Provided
 
Modified Relaxation (MR) Technique for Treating Hypertension in Postmenopausal Women
Phase 3 Study of 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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Postmenopausal Syndrome
  • Hypertension
  • 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
  • Behavioral: Lifestyle Education (LE)
    Participants in this group will receive conventional care and lifestyle education on dietary choice and exercise.
    Other Name: Lifestyle Modification
  • Sham Comparator: Lifestyle Education (LE)
    Lifestyle Education (LE) Participants in this group will receive conventional care and lifestyle education on dietary choice and exercise.
    Intervention: Behavioral: Lifestyle Education (LE)
  • 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.
    Intervention: Behavioral: Modified Relaxation (MR)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
429
March 2012
March 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
45 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
 
NCT01429662
MRLE-HTN
Yes
Not Provided
Not Provided
Suprawita Saensak, Chiang Mai University
Chiang Mai University
Not Provided
Principal Investigator: Suprawita Saensak, PhDcandidate PhD in Clinical Epidemiology Program, Faculty of Medicine, Chiang Mai University (Thailand)
Chiang Mai University
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP