Applied Relaxation (AR) Technique Versus Its Modified Version for Treating Menopausal Symptoms
NCT ID: NCT01429636
Last Updated: 2011-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
60 participants
INTERVENTIONAL
2011-08-31
2011-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Applied Relaxation (AR)
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.
Modified Relaxation (MR)
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Women who have at least 5 points of MRS score.
Exclusion Criteria
* Women with uncontrolled hypertension (\>95mmHg diastolic pressure) or daily use of sedatives, tranquilizer or antidepressant medication.
45 Years
65 Years
FEMALE
No
Sponsors
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Chiang Mai University
OTHER
Responsible Party
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Suprawita Saensak
Phase 3 Study of Applied Relaxation (AR) Technique versus Its Modified Version for Treating Menopausal Symptoms.
Principal Investigators
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Suprawita - Saensak, PhDcandidate
Role: PRINCIPAL_INVESTIGATOR
PhD in Clinical Epidemiology Program, Faculty of Medicine, Chiang Mai University (Thailand)
Locations
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Mahassarakham Hospital
Maha Sarakham, Northeast, Thailand
Countries
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Related Links
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NIH is the nation's medical research agency-supporting scientific studies that turn discovery into health.
PubMed comprises more than 21 million citations for biomedical literature from MEDLINE, life science journals, and online books.
Elsevier is committed to making genuine contributions to the science and health communities.
The Journal of The North American Menopause Society is a peer-reviewed scientific journal owned by NAMS and published by Lippincott Williams \& Wilkins (LWW).
The International Journal of Clinical and Health Psychology.
The world's largest collection of STM books, journals, protocol and reference works.
Other Identifiers
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ARMR-Sympts
Identifier Type: -
Identifier Source: org_study_id