Menopausal Treatment Using Relaxation Exercises (MaTURE)

Hot Flashes Clinical Trial

— MaTURE  

Official title:

Menopausal Treatment Using Relaxation Exercises (MaTURE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01466998
• Other study ID #: R01AT005491
• Status: Completed
• Phase: N/A
• First received: November 1, 2011
• Last updated: May 5, 2014
• Start date: January 2012
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 59 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hot Flashes
• Hot Flushes

Intervention

Other:
• Paced Respiration
Practice paced respiration 15 minutes per day for a total of 12 weeks.
• Music Therapy
Practice music therapy for 15 minutes per day for a total of 12 weeks.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in average daily frequency of hot flashes.		4-Weeks and 12-Weeks	No
Secondary	Change in subjective severity of hot flashes.		4-weeks and 12-weeks	No
Secondary	Change in sympathetic and parasympathetic autonomic nervous system tone.		12 weeks	No
Secondary	Change in quality-of-of life measures associated with hot flashes.		Weeks 4 and Weeks 12	No