Hypertension, Postmenopausal Syndrome
Conditions
Keywords
postmenopause, hypertension, relaxation, SBP 140-159 mmHg, DBP 90-99 mmHg, stage 1 or mild hypertension
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.
Interventions
BEHAVIORALModified 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.
BEHAVIORALLifestyle Education (LE)
Participants in this group will receive conventional care and lifestyle education on dietary choice and exercise.
Sponsors
Chiang Mai University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in SBP. | 16 weeks | Measure the systolic blood pressure (SBP) after intervention at 1, 2 ,3 , and 4 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drop-out rates. | 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. | 16 weeks | Measure the numbers of subjects who require anti-hypertensive medication after intervention 4 months of follow-up period. |
| Changes in DBP. | 16 weeks | Measure the diastolic blood pressure (DBP) after intervention at 1, 2 ,3 , and 4 months. |
| Continuation rate of MR practice. | 16 weeks | Measure the continuation rate of MR practice after 4 months of follow-up period. |
Countries
Thailand
Outcome results
None listed