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Applied Relaxation for Vasomotor Symptoms

NCT01488864 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2012-05-11

No results posted yet for this study

Summary

The objectives of this study are to compare frequency and severity of moderate to severe vasomotor symptoms in postmenopausal women treated with applied relaxation (AR) with an untreated control-group (CG) and to investigate if Health Related Quality of Life improve in the AR-group compared to an untreated CG.To study if salivary cortisol excretion would change within the AR treated group compared with the control group.

Conditions

Interventions

BEHAVIORAL

Applied Relaxation (AR)

AR is a technique influenced on cognitive behavioral therapy using coping mechanism and conditioning. AR focuses on muscle relaxation, where breathing is used for the conditioning of the relaxation. AR implies participation in 10 group sessions during a period of 12 weeks. A therapist will see the women assigned to AR in a group consisted of 6-8 women. The weekly sessions will last for 60 minutes each and are based on a scheme from Öst. The women will be told to practice each component daily. During the first session a lecture about menopause and about theories of the mechanisms behind hot flashes will be given. The aim of applying AR in view of coping with vasomotor symptoms will be discussed. The group is given a rationale of applying AR as a coping technique for handling sudden unanticipated symptoms by quick calming down, and thus gaining control over the situation.

Sponsors & Collaborators

  • Elizabeth Nedstrand

    lead OTHER

Principal Investigators

  • Elizabeth Nedstrand, Md, PhD · Ostergotland CC, University Hospital Dept. of Obstetrics and Gynecology, 582 85 Linköping, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01488864 on ClinicalTrials.gov