Applied Relaxation (AR) Technique Versus Its Modified Version for Treating Menopausal Symptoms
Phase 3 Study of Applied Relaxation (AR) Technique That Treating Menopausal Symptoms
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2011
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 1, 2011
CompletedFirst Posted
Study publicly available on registry
September 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedDecember 30, 2011
December 1, 2011
4 months
September 1, 2011
December 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in global scores of Menopausal Rating Scale (MRS).
MRS measure after intervention at 1, 2 and 3 months for follow-up.
12 weeks
Secondary Outcomes (3)
Change in the frequency and severity of hot flushes.
12 weeks
Change in the frequency and severity of night sweats.
12 weeks
Change in the frequency and severity of sleep disturbances.
12 weeks
Study Arms (2)
Applied Relaxation (AR)
EXPERIMENTALModified Relaxation (MR)
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- Perimenopausal women and postmenopausal women with either surgical or spontaneous menopause.
- Women who have at least 5 points of MRS score.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mahassarakham Hospital
Maha Sarakham, Northeast, 44000, Thailand
Related Links
- 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.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suprawita - Saensak, PhDcandidate
PhD in Clinical Epidemiology Program, Faculty of Medicine, Chiang Mai University (Thailand)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Phase 3 Study of Applied Relaxation (AR) Technique versus Its Modified Version for Treating Menopausal Symptoms.
Study Record Dates
First Submitted
September 1, 2011
First Posted
September 7, 2011
Study Start
August 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
December 30, 2011
Record last verified: 2011-12