Menopausal Treatment Using Relaxation Exercises (MaTURE)

Study Overview
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Brief Summary
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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.

Official Title
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Menopausal Treatment Using Relaxation Exercises (MaTURE)

Conditions
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Hot Flushes, Hot Flashes

Intervention / Treatment
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* Other: Paced Respiration
* Other: Music Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paced Respiration<br>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<br>* Practice paced respiration 15 minutes per day for a total of 12 weeks.<br>|
| Active Comparator: Music Therapy<br>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<br>* Practice music therapy for 15 minutes per day for a total of 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in average daily frequency of hot flashes. |  | 4-Weeks and 12-Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in subjective severity of hot flashes. |  | 4-weeks and 12-weeks | 
| Change in sympathetic and parasympathetic autonomic nervous system tone. |  | 12 weeks | 
| Change in quality-of-of life measures associated with hot flashes. |  | Weeks 4 and Weeks 12 |