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OpenTrials
Completed

NCT Number: NCT01466998

Menopausal Treatment Using Relaxation Exercises (MaTURE)

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.

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Key information

Age range

40 year–59 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94115, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Paced Respiration

Other

Practice paced respiration 15 minutes per day for a total of 12 weeks.

Music Therapy

Other

Practice music therapy for 15 minutes per day for a total of 12 weeks.

Primary outcomes

  1. Change in average daily frequency of hot flashes.

    Time frame: 4-Weeks and 12-Weeks

Secondary outcomes

  1. Change in subjective severity of hot flashes.

    Time frame: 4-weeks and 12-weeks

  2. Change in sympathetic and parasympathetic autonomic nervous system tone.

    Time frame: 12 weeks

  3. Change in quality-of-of life measures associated with hot flashes.

    Time frame: Weeks 4 and Weeks 12

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Acronym: MaTURE

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 8, 2011
Registry last updated
May 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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