Menopausal Treatment Using Relaxation Exercises (MaTURE)

NCT ID: NCT01466998

Last Updated: 2014-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Paced Respiration

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Music Therapy

Intervention Type: OTHER

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

Interventions

Paced Respiration

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

Intervention Type: OTHER

Music Therapy

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Deborah Grady

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deborah Grady, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Alison Huang, MD, MAS

Role: STUDY_DIRECTOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25932840 (View on PubMed)

Other Identifiers

R01AT005491

Identifier Type: NIH

Identifier Source: org_study_id

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