Applied Relaxation (AR) Technique Versus Its Modified Version for Treating Menopausal Symptoms
Condition: Hot Flashes; Night Sweats; Sleep Disturbances
MeSH terms: Dyssomnias; Parasomnias; Hot Flashes
Study type: Interventional
Phase: Phase 3

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.
    

Detailed 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.
    

Intervention name(s): Modified Relaxation (MR); Applied Relaxation (AR)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.
Other intervention name(s): Behavioral relaxation; Behavioral Applied Relaxation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: perimenopause; postmenopause; vasomotor symptoms; relaxation