Menopausal Treatment Using Relaxation Exercises (MaTURE)

NCT01466998 | Completed DMC

• 1 other identifier: R01AT005491
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Hot Flushes; Hot Flashes

Outcome Measures

Primary Outcomes (1)

• Change in average daily frequency of hot flashes.

  4-Weeks and 12-Weeks

Secondary Outcomes (3)

• 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

Study Arms (2)

Paced Respiration

EXPERIMENTAL

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

Music Therapy

ACTIVE COMPARATOR

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

Interventions

Paced Respiration OTHER

Practice paced respiration 15 minutes per day for a total of 12 weeks.

Paced Respiration

Music Therapy OTHER

Practice music therapy for 15 minutes per day for a total of 12 weeks.

Music Therapy

Eligibility Criteria

• Age: 40 Years - 59 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94115, United States

Location

Related Publications (1)

• 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.

  PMID: 25932840 DERIVED

MeSH Terms

Conditions

Hot Flashes

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Deborah Grady, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Alison Huang, MD, MAS

  University of California, San Francisco

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 1, 2011
• First Posted: November 8, 2011
• Study Start: January 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 6, 2014

Record last verified: 2014-05

Locations

US (1)