Menopausal Treatment Using Relaxation Exercises (MaTURE) (MaTURE)
|ClinicalTrials.gov Identifier: NCT01466998|
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : May 6, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hot Flushes Hot Flashes||Other: Paced Respiration Other: Music Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||123 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Menopausal Treatment Using Relaxation Exercises (MaTURE)|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
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.
- Change in average daily frequency of hot flashes. [ Time Frame: 4-Weeks and 12-Weeks ]
- Change in subjective severity of hot flashes. [ Time Frame: 4-weeks and 12-weeks ]
- Change in sympathetic and parasympathetic autonomic nervous system tone. [ Time Frame: 12 weeks ]
- Change in quality-of-of life measures associated with hot flashes. [ Time Frame: Weeks 4 and Weeks 12 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01466998
|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|