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

Chiang Mai University

Status and phase

Completed

Phase 3

Conditions

Night Sweats

Hot Flashes

Sleep Disturbances

Treatments

Behavioral: Applied Relaxation (AR)

Behavioral: Modified Relaxation (MR)

Study type

Interventional

Funder types

Other

Identifiers

NCT01429636

ARMR-Sympts

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

Female

Ages

45 to 65 years old

Volunteers

No Healthy Volunteers

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.