Menopausal Treatment Using Relaxation Exercises (MaTURE) (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 Overview

• Status: Completed
• Conditions: Hot Flashes; Hot Flushes
• Intervention / Treatment: Other: Paced Respiration; Other: Music Therapy

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 59 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria

1. Women aged 40 through 59 years at the time of screening.
2. Perinenopausal or postmenopausal.
3. Adequate adherence to study procedures during a 1-week run-in.
4. At least 4 hot flashes per 24 hours recorded by a hot flash monitor and diary.
5. Capable of understanding study procedures and giving informed consent.
6. Willing to refrain from using other treatments for hot flashes during the study period.

Exclusion criteria

1. Pregnant or breastfeeding in the past year.
2. Current or recent use of medications known to affect hot flashes.
3. Resting blood pressure less than 100/60.
4. Spontaneous resting breathing rate less than 10 breaths/minute.
5. Chronic medical therapy for pulmonary disease.
6. Known sensitivity to adhesives.
7. Cardiac pacemaker or implanted defibrillator.
8. No access to a telephone.
9. Plans to move out of the area or travel by airplane in ways that would interfere with the study.
10. Inability to sign an informed consent, participate in interviews, or understand and complete questionnaires in English.
11. Report conditions that, in the judgment of the investigators, render potential participants unlikely to follow the protocol.
12. Participation in another research study involving investigational drugs or devices.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in average daily frequency of hot flashes.	4-Weeks and 12-Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Study Director: Alison Huang, MD, MAS, University of California, San Francisco

Publications and helpful links

General Publications

• Huang AJ, Phillips S, Schembri M, Vittinghoff E, Grady D. Device-guided slow-paced respiration for menopausal hot flushes: a randomized controlled trial. Obstet Gynecol. 2015 May;125(5):1130-1138. doi: 10.1097/AOG.0000000000000821.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): April 1, 2014
• Study Completion (ACTUAL): April 1, 2014

Study Registration Dates

• First Submitted: November 1, 2011
• First Submitted That Met QC Criteria: November 3, 2011
• First Posted (ESTIMATE): November 8, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): May 6, 2014
• Last Update Submitted That Met QC Criteria: May 5, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hot Flashes
• Other Study ID Numbers: R01AT005491 (NIH)