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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Suprawita Saensak, Chiang Mai University
ClinicalTrials.gov Identifier:
NCT01429636
First received: September 1, 2011
Last updated: December 28, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Hot Flashes
Night Sweats
Sleep Disturbances
Behavioral: Modified Relaxation (MR)
Behavioral: Applied Relaxation (AR)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3 Study of Applied Relaxation (AR) Technique That Treating Menopausal Symptoms

Resource links provided by NLM:


Further study details as provided by Chiang Mai University:

Primary Outcome Measures:
  • Changes in global scores of Menopausal Rating Scale (MRS). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    MRS measure after intervention at 1, 2 and 3 months for follow-up.


Secondary Outcome Measures:
  • Change in the frequency and severity of hot flushes. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measure the frequency and severity of hot flushes after intervention at 1, 2 and 3 months.

  • Change in the frequency and severity of night sweats. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measure the frequency and severity of night sweats after intervention at 1, 2, and 3 months.

  • Change in the frequency and severity of sleep disturbances. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measure the frequency and severity of sleep disturbances after intervention at 1, 2, and 3 months.


Enrollment: 60
Study Start Date: August 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Applied Relaxation (AR) Behavioral: 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.
Other Name: Behavioral Applied Relaxation
Experimental: Modified Relaxation (MR) 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.
Other Name: Behavioral relaxation

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.

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01429636

Locations
Thailand
Mahassarakham Hospital
Maha Sarakam, Northeast, Thailand, 44000
Sponsors and Collaborators
Chiang Mai University
Investigators
Principal Investigator: Suprawita - Saensak, PhDcandidate PhD in Clinical Epidemiology Program, Faculty of Medicine, Chiang Mai University (Thailand)
  More Information

Additional Information:
No publications provided

Responsible Party: Suprawita Saensak, Phase 3 Study of Applied Relaxation (AR) Technique versus Its Modified Version for Treating Menopausal Symptoms., Chiang Mai University
ClinicalTrials.gov Identifier: NCT01429636     History of Changes
Other Study ID Numbers: ARMR-Sympts
Study First Received: September 1, 2011
Last Updated: December 28, 2011
Health Authority: Thailand: Ministry of Public Health

Keywords provided by Chiang Mai University:
perimenopause
postmenopause
vasomotor symptoms
relaxation

Additional relevant MeSH terms:
Sleep Disorders
Dyssomnias
Parasomnias
Hot Flashes
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on April 22, 2014