Applied Relaxation (AR) Technique Versus Its Modified Version for Treating Menopausal Symptoms

Hot Flashes Clinical Trial

Official title:

Phase 3 Study of Applied Relaxation (AR) Technique That Treating Menopausal Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01429636
• Other study ID #: ARMR-Sympts
• Status: Completed
• Phase: Phase 3
• First received: September 1, 2011
• Last updated: December 28, 2011
• Start date: August 2011
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyssomnias
• Hot Flashes
• Night Sweats
• Parasomnias
• Sleep Disorders
• Sleep Disturbances

Intervention

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.
• 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.

Locations

Country	Name	City	State
Thailand	Mahassarakham Hospital	Maha Sarakam	Northeast

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in global scores of Menopausal Rating Scale (MRS).	MRS measure after intervention at 1, 2 and 3 months for follow-up.	12 weeks	No
Secondary	Change in the frequency and severity of hot flushes.	Measure the frequency and severity of hot flushes after intervention at 1, 2 and 3 months.	12 weeks	No
Secondary	Change in the frequency and severity of night sweats.	Measure the frequency and severity of night sweats after intervention at 1, 2, and 3 months.	12 weeks	No
Secondary	Change in the frequency and severity of sleep disturbances.	Measure the frequency and severity of sleep disturbances after intervention at 1, 2, and 3 months.	12 weeks	No

External Links

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•   The International Journal of Clinical and Health Psychology.
•   The Journal of The North American Menopause Society is a peer-reviewed scientific journal owned by NAMS and published by Lippincott Williams & Wilkins (LWW).