Clinical trial NCT01466998: Menopausal Treatment Using Relaxation Exercises (MaTURE)
Official title: Menopausal Treatment Using Relaxation Exercises (MaTURE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hot Flushes
Hot Flashes
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2011-11-08
Enrollment: 123
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in average daily frequency of hot flashes.
timeFrame: 4-Weeks and 12-Weeks
Secondary outcomes:
measure: Change in subjective severity of hot flashes.
timeFrame: 4-weeks and 12-weeks
measure: Change in sympathetic and parasympathetic autonomic nervous system tone.
timeFrame: 12 weeks
measure: Change in quality-of-of life measures associated with hot flashes.
timeFrame: Weeks 4 and Weeks 12
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Deborah Grady, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Alison Huang, MD, MAS
role: STUDY_DIRECTOR
References:
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.