Menopausal Treatment Using Relaxation Exercises (MaTURE)
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Menopausal Treatment Using Relaxation Exercises (MaTURE)|
- Change in average daily frequency of hot flashes. [ Time Frame: 4-Weeks and 12-Weeks ] [ Designated as safety issue: No ]
- Change in subjective severity of hot flashes. [ Time Frame: 4-weeks and 12-weeks ] [ Designated as safety issue: No ]
- Change in sympathetic and parasympathetic autonomic nervous system tone. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change in quality-of-of life measures associated with hot flashes. [ Time Frame: Weeks 4 and Weeks 12 ] [ Designated as safety issue: No ]
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Experimental: 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.
Other: Paced Respiration
Practice paced respiration 15 minutes per day for a total of 12 weeks.
Active Comparator: 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.
Other: Music Therapy
Practice music therapy for 15 minutes per day for a total of 12 weeks.
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Deborah Grady, MD, MPH||University of California, San Francisco|
|Study Director:||Alison Huang, MD, MAS||University of California, San Francisco|