Menopausal Treatment Using Relaxation Exercises (MaTURE)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Deborah Grady, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01466998
First received: November 1, 2011
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Hot Flushes
Hot Flashes
Other: Paced Respiration
Other: Music Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Menopausal Treatment Using Relaxation Exercises (MaTURE)

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Change in average daily frequency of hot flashes. [ Time Frame: 4-Weeks and 12-Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in subjective severity of hot flashes. [ Time Frame: 4-weeks and 12-weeks ] [ Designated as safety issue: No ]
  • Change in sympathetic and parasympathetic autonomic nervous system tone. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in quality-of-of life measures associated with hot flashes. [ Time Frame: Weeks 4 and Weeks 12 ] [ Designated as safety issue: No ]

Enrollment: 123
Study Start Date: January 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   40 Years to 59 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01466998

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Deborah Grady, MD, MPH University of California, San Francisco
Study Director: Alison Huang, MD, MAS University of California, San Francisco
  More Information

No publications provided

Responsible Party: Deborah Grady, Professor of Medicine, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01466998     History of Changes
Other Study ID Numbers: R01AT005491
Study First Received: November 1, 2011
Last Updated: May 5, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014