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Completed

NCT Number: NCT01429636

Applied Relaxation (AR) Technique Versus Its Modified Version for 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.

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Key information

Conditions

Hot Flashes Mental Disorders Nervous System Diseases Night Sweats Parasomnias Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disturbances Sleep Wake Disorders

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Mahassarakham Hospital

Maha Sarakham, Northeast, 44000, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Modified Relaxation (MR)

Behavioral

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.

Other names: Behavioral relaxation

Applied Relaxation (AR)

Behavioral

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 names: Behavioral Applied Relaxation

Primary outcomes

  1. Changes in global scores of Menopausal Rating Scale (MRS).

    Time frame: 12 weeks

    MRS measure after intervention at 1, 2 and 3 months for follow-up.

Secondary outcomes

  1. Change in the frequency and severity of hot flushes.

    Time frame: 12 weeks

    Measure the frequency and severity of hot flushes after intervention at 1, 2 and 3 months.

  2. Change in the frequency and severity of night sweats.

    Time frame: 12 weeks

    Measure the frequency and severity of night sweats after intervention at 1, 2, and 3 months.

  3. Change in the frequency and severity of sleep disturbances.

    Time frame: 12 weeks

    Measure the frequency and severity of sleep disturbances after intervention at 1, 2, and 3 months.

Sponsors and collaborators

Lead sponsor

Chiang Mai University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Sep 7, 2011
Registry last updated
Dec 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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