Menopausal Treatment Using Relaxation Exercises (MaTURE)

Not Applicable

Completed

• Conditions: Hot Flushes; Hot Flashes
• Interventions: Other: Paced Respiration; Other: Music Therapy

• Registration Number: NCT01466998
• Lead Sponsor: University of California, San Francisco

Brief Summary

Hot flashes occur in as many as two thirds of U.S. women during menopause and are severe enough to require treatment in 20%. Although postmenopausal hormone therapy is effective in suppressing hot flashes, it is associated with increased risk for a variety of serious adverse effects. There is an urgent need for alternative treatments that are effective, safe, and easy to use. In this study, the investigators will compare two different types of behavioral relaxation therapies, paced respiration and music therapy, for treatment of menopausal hot flashes. Effects on frequency of hot flashes, other symptom and quality-of-life outcomes associated with hot flashes, and physiologic measures of sympathetic/parasympathetic activity will be examined.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-01
• Study First Submitted QC: 2011-11-03
• Study First Posted: 2011-11-08
• Study Start: 2012-01
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-05
• Last Update Posted: 2014-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 123

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paced Respiration	Paced Respiration	Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.
Music Therapy	Music Therapy	Participant will use an identical appearing device, programmed to play quiet, relaxing non-rhythmic music while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change in average daily frequency of hot flashes.	4-Weeks and 12-Weeks

Secondary Outcome Measures

Name	Time	Method
Change in subjective severity of hot flashes.	4-weeks and 12-weeks
Change in sympathetic and parasympathetic autonomic nervous system tone.	12 weeks
Change in quality-of-of life measures associated with hot flashes.	Weeks 4 and Weeks 12

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States