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

Primary Purpose

Hot Flashes, Night Sweats, Sleep Disturbances

Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Modified Relaxation (MR)
Applied Relaxation (AR)
Sponsored by
Chiang Mai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hot Flashes focused on measuring perimenopause, postmenopause, vasomotor symptoms, relaxation

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Mahassarakham Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Applied Relaxation (AR)

Modified Relaxation (MR)

Arm Description

Outcomes

Primary Outcome Measures

Changes in global scores of Menopausal Rating Scale (MRS).
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.
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.
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.
Measure the frequency and severity of sleep disturbances after intervention at 1, 2, and 3 months.

Full Information

First Posted
September 1, 2011
Last Updated
December 28, 2011
Sponsor
Chiang Mai University
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1. Study Identification

Unique Protocol Identification Number
NCT01429636
Brief Title
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

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chiang Mai University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes, Night Sweats, Sleep Disturbances
Keywords
perimenopause, postmenopause, vasomotor symptoms, relaxation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Applied Relaxation (AR)
Arm Type
Experimental
Arm Title
Modified Relaxation (MR)
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Modified Relaxation (MR)
Other Intervention Name(s)
Behavioral relaxation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Applied Relaxation (AR)
Other Intervention Name(s)
Behavioral Applied Relaxation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in global scores of Menopausal Rating Scale (MRS).
Description
MRS measure after intervention at 1, 2 and 3 months for follow-up.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in the frequency and severity of hot flushes.
Description
Measure the frequency and severity of hot flushes after intervention at 1, 2 and 3 months.
Time Frame
12 weeks
Title
Change in the frequency and severity of night sweats.
Description
Measure the frequency and severity of night sweats after intervention at 1, 2, and 3 months.
Time Frame
12 weeks
Title
Change in the frequency and severity of sleep disturbances.
Description
Measure the frequency and severity of sleep disturbances after intervention at 1, 2, and 3 months.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suprawita - Saensak, PhDcandidate
Organizational Affiliation
PhD in Clinical Epidemiology Program, Faculty of Medicine, Chiang Mai University (Thailand)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mahassarakham Hospital
City
Maha Sarakam
State/Province
Northeast
ZIP/Postal Code
44000
Country
Thailand

12. IPD Sharing Statement

Links:
URL
http://www.nih.gov
Description
NIH is the nation's medical research agency-supporting scientific studies that turn discovery into health.
URL
http://www.ncbi.nlm.nih.gov/pubmed
Description
PubMed comprises more than 21 million citations for biomedical literature from MEDLINE, life science journals, and online books.
URL
http://www.elsevier.com
Description
Elsevier is committed to making genuine contributions to the science and health communities.
URL
http://www.menopause.org
Description
The Journal of The North American Menopause Society is a peer-reviewed scientific journal owned by NAMS and published by Lippincott Williams & Wilkins (LWW).
URL
http://www.aepc.es/ijchp
Description
The International Journal of Clinical and Health Psychology.
URL
http://www.springer.com/medicine/journal
Description
The world's largest collection of STM books, journals, protocol and reference works.

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

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