Hot Flashes Clinical Trial
Official title:
Phase 3 Study of Applied Relaxation (AR) Technique That Treating Menopausal Symptoms
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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