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Menopausal Treatment Using Relaxation Exercises (MaTURE) (MaTURE)

Primary Purpose

Hot Flushes, Hot Flashes

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Paced Respiration

Music Therapy

About this trial

This is an interventional treatment trial for Hot Flushes

Eligibility Criteria

40 Years - 59 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria

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.

Exclusion criteria

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.

Sites / Locations

University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Paced Respiration

Music Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in average daily frequency of hot flashes.

Secondary Outcome Measures

Change in subjective severity of hot flashes.

Change in sympathetic and parasympathetic autonomic nervous system tone.

Change in quality-of-of life measures associated with hot flashes.

Full Information

NCT ID

NCT01466998

First Posted

November 1, 2011

Last Updated

May 5, 2014

Sponsor

University of California, San Francisco

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

1. Study Identification

Unique Protocol Identification Number

NCT01466998

Brief Title

Menopausal Treatment Using Relaxation Exercises (MaTURE)

Acronym

MaTURE

Official Title

Menopausal Treatment Using Relaxation Exercises (MaTURE)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, San Francisco

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hot Flushes, Hot Flashes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

123 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Paced Respiration

Arm Type

Experimental

Arm Description

Arm Title

Music Therapy

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Paced Respiration

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Music Therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in average daily frequency of hot flashes.

Time Frame

4-Weeks and 12-Weeks

Secondary Outcome Measure Information:

Title

Change in subjective severity of hot flashes.

Time Frame

4-weeks and 12-weeks

Title

Change in sympathetic and parasympathetic autonomic nervous system tone.

Time Frame

12 weeks

Title

Change in quality-of-of life measures associated with hot flashes.

Time Frame

Weeks 4 and Weeks 12

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria 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. Exclusion criteria 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Deborah Grady, MD, MPH

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Alison Huang, MD, MAS

Organizational Affiliation

University of California, San Francisco

Official's Role

Study Director

Facility Information:

Facility Name

University of California, San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25932840

Citation

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.

Results Reference

derived

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Menopausal Treatment Using Relaxation Exercises (MaTURE)

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