Applied Relaxation (AR) Technique Versus Its Modified Version for Treating Menopausal Symptoms
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Purpose
The purpose of this study is to demonstrate better efficacy and effectiveness of modified applied relaxation technique over its original version for treating menopausal symptoms.
| Condition | Intervention | Phase |
|---|---|---|
|
Hot Flashes Night Sweats Sleep Disturbances |
Behavioral: Modified Relaxation (MR) Behavioral: Applied Relaxation (AR) |
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 Applied Relaxation (AR) Technique That Treating Menopausal Symptoms |
- Changes in global scores of Menopausal Rating Scale (MRS). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]MRS measure after intervention at 1, 2 and 3 months for follow-up.
- Change in the frequency and severity of hot flushes. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Measure the frequency and severity of hot flushes after intervention at 1, 2 and 3 months.
- Change in the frequency and severity of night sweats. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Measure the frequency and severity of night sweats after intervention at 1, 2, and 3 months.
- Change in the frequency and severity of sleep disturbances. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Measure the frequency and severity of sleep disturbances after intervention at 1, 2, and 3 months.
| Enrollment: | 60 |
| Study Start Date: | August 2011 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Applied Relaxation (AR) |
Behavioral: Applied Relaxation (AR)
Participants will receive 12 sessions AR training. After that they will asked to practice at home once a day for 15-20 minutes during their leisure times, at least 5 days a week for the whole 12 weeks of the follow-up period.
Other Name: Behavioral Applied Relaxation
|
| Experimental: Modified Relaxation (MR) |
Behavioral: Modified Relaxation (MR)
The MR technique is modified from the AR technique that will require participants to attend only 1 session, lasting 60 minutes. After the training session, participants will be given a hand-out on MR. They will continue to practice MR at home once a day for 15-20 minutes during their leisure times, at least 5 days a week for the whole 12 weeks of the follow-up period.
Other Name: Behavioral relaxation
|
Detailed Description:
Applied Relaxation (AR) is the most commonly used behavioral methods for treating menopausal symptoms. Many clinical trials reported that the technique effectively improved vasomotor and related symptoms. There is a strong evidence to support its continue use in clinical settings.
However, the original AR technique is too cumbersome. It involves intensive training once a week for 12 consecutive weeks. Each weekly session takes 60 minutes, and subjects are requested to do self-practice at home for at least 15-20 minutes/day. As such, >25% of recruited subjects drop out from the training course. The investigators have modified the original AR technique by reducing the duration of training to only once, lasting 60 minutes. Participants are requested to do self-practice at home for 15-20 minutes/day as in the original technique. Instead of coming to a weekly class, the investigators use telephone to communicate with the subjects once a week for 12 consecutive weeks. A preliminary study showed all 10 recruited subjects remained in the study (MR; modified relaxation technique) until completion. They all reported dramatic improvement in their vasomotor symptoms.
In this study, the investigators propose to compare our modified version of AR with the original method in a randomized controlled clinical trial. The subjects will be Thai menopausal women with vasomotor symptoms. The main outcomes are the reduction in the MRS score (intensity of hot flushes, night sweats and sleep disturbances) among those who remain in the program at the end of the study (efficacy evaluation). As nearly all patients will remain in the MR group, while >25% of those in the AR group will be expected to drop out from the study, the investigators should be able to demonstrate a superiority of MR over AR in terms of effectiveness as well.
Eligibility| Ages Eligible for Study: | 45 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Perimenopausal women and postmenopausal women with either surgical or spontaneous menopause.
- Women who have at least 5 points of MRS score.
Exclusion Criteria:
- Women who are taking any hormone therapy for any reason in the past three months prior to entering the trails.
- Women with uncontrolled hypertension (>95mmHg diastolic pressure) or daily use of sedatives, tranquilizer or antidepressant medication.
Contacts and Locations| Thailand | |
| Mahassarakham Hospital | |
| Maha Sarakam, Northeast, Thailand, 44000 | |
| 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, Phase 3 Study of Applied Relaxation (AR) Technique versus Its Modified Version for Treating Menopausal Symptoms., Chiang Mai University |
| ClinicalTrials.gov Identifier: | NCT01429636 History of Changes |
| Other Study ID Numbers: | ARMR-Sympts |
| Study First Received: | September 1, 2011 |
| Last Updated: | December 28, 2011 |
| Health Authority: | Thailand: Ministry of Public Health |
Keywords provided by Chiang Mai University:
|
perimenopause postmenopause vasomotor symptoms relaxation |
Additional relevant MeSH terms:
|
Sleep Disorders Dyssomnias Parasomnias Hot Flashes |
Nervous System Diseases Neurologic Manifestations Signs and Symptoms Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013