Menopausal Treatment Using Relaxation Exercises (MaTURE)
| Status: | Completed |
|---|---|
| Conditions: | Hot Flash |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 40 - 59 |
| Updated: | 1/1/2014 |
| Start Date: | January 2012 |
| End Date: | June 2014 |
| Contact: | Ann Chang, BS |
| Email: | ann.chang@ucsfmedctr.org |
| Phone: | 415-885-7547 |
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.
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.
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.
We found this trial at
1
site
533 Parnassus Ave
San Francisco, California 94122
San Francisco, California 94122
(415) 476-9000
University of California - San Francisco The leading university exclusively focused on health, UC San...
Click here to add this to my saved trials
