Applied Relaxation for Vasomotor Symptoms

May 10, 2012 updated by: Elizabeth Nedstrand

Applied Relaxation for Vasomotor Symptoms in Postmenopausal Women - a Randomized, Controlled Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Approximately 70% of women in Europe and North America experience hot flashes and night sweats during the climacteric period. Many women abstain from hormonal therapy because of side effects or contraindications such as breast cancer or thrombosis.

Different alternative therapies for alleviation of hot flashes are described in the literature. Both pharmacological treatments, different types of natural remedies, acupuncture, life-style changes and mind-body therapies are suggested as promising therapies. Applied relaxation (AR) is a technique influenced on cognitive behavioral therapy (CBT) using coping mechanism and conditioning. Previous study with healthy postmenopausal women showed promising results on hot flash frequency with an average decrease of more than 70 % with persisting effect three months after therapy and also HRQoL significantly increased probably due to better sleep and diminished vasomotor symptoms. But the method must be further investigated before strong evidence-based conclusion can be drawn.

Cortisol is a potent stress hormone regulated by the hypothalamic-pituitary axis. The factors underlying how alternative treatment works and the mechanism underlying improvements in symptoms are not fully understood.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Linköping, Sweden, 5851 85
        • University Hospital, Dept of Obstetrics and Gynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • postmenopausal women (at least 12 months since last menstrual bleeding occurred or in previously hysterectomised women a serum follicle-stimulating hormone (S-FSH) defined as postmenopausal level according to references at the local laboratory)
  • More or equal to 7 moderate to severe hot flashes or more or equal at 50 hot flashes per week according to a two-week screening diary
  • ability to understand and speak Swedish
  • freely given informed consent

Exclusion Criteria:

  • unstable thyroid or other metabolic disease
  • treatment with hormone therapy (HT) or other complementary- or alternative treatments treatment for menopausal-related symptoms
  • treatment with psychopharmacological drugs and/or sedatives d-un-treated psychiatric disease
  • frequently exercising women (≥ 2h high-intensity activities/week)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Applied Relaxation (AR)
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.
No Intervention: Untreated Control Group (CG)
The women assigned to CG will be told to act as an untreated control group i.e. not to use hormonal treatment, other alternative medication, natural remedies for hot flashes and even not acupuncture, mind-body therapies or intensive physical activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hot flashes average number and severity
Time Frame: Baseline to 12 week after "start of treatment"
The average number and severity of hot flashes/24 hours in self-registered diaries during the 12th week
Baseline to 12 week after "start of treatment"

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hot flashes
Time Frame: Baseline to 3 months after "end of treatment"
The average number and severity of hot flashes per 24 hours after 3 months follow-up.
Baseline to 3 months after "end of treatment"
Hot flashes reduction of hot flashes
Time Frame: Baseline to 3 months after "end of treatment"
The reduction of hot flashes in women defined as responders. Responders are defined as women with ≥50% reduction of hot flashes.
Baseline to 3 months after "end of treatment"
Health Related Quality of Life
Time Frame: Baseline to 3 months "end of treatment"
The total score in the Women Health Questionnaire measured at 12th week and after 3 months follow-up.
Baseline to 3 months "end of treatment"
Adverse Events
Time Frame: Baseline to 3 months "end of treatment"
Adverse events documented by means of using open-ended questions at each contact.
Baseline to 3 months "end of treatment"
Salivary cortisol
Time Frame: Baseline to 3 months after "end-of-treatment"
Three samples of salivary cortisol (at awakening, 30 minutes after awakening, and at bedtime)were collected at baseline, after 12 weeks and 3 months after "end-of-treatment"
Baseline to 3 months after "end-of-treatment"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elizabeth Nedstrand

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

December 6, 2011

First Submitted That Met QC Criteria

December 7, 2011

First Posted (Estimate)

December 8, 2011

Study Record Updates

Last Update Posted (Estimate)

May 11, 2012

Last Update Submitted That Met QC Criteria

May 10, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LiÖ/AR-2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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