Clinical trial NCT01429636: Applied Relaxation (AR) Technique Versus Its Modified Version for Treating Menopausal Symptoms
Official title: Phase 3 Study of Applied Relaxation (AR) Technique That Treating Menopausal Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hot Flashes
Night Sweats
Sleep Disturbances
Keywords: perimenopause
postmenopause
vasomotor symptoms
relaxation
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2011-09-07
Enrollment: 60
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Changes in global scores of Menopausal Rating Scale (MRS).
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in the frequency and severity of hot flushes.
timeFrame: 12 weeks
measure: Change in the frequency and severity of night sweats.
timeFrame: 12 weeks
measure: Change in the frequency and severity of sleep disturbances.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Maha Sarakam
country: Thailand
facility: Mahassarakham Hospital
state: Northeast
Study officials:
affiliation: PhD in Clinical Epidemiology Program, Faculty of Medicine, Chiang Mai University (Thailand)
name: Suprawita - Saensak, PhDcandidate
role: PRINCIPAL_INVESTIGATOR
References: