Applied Relaxation for Vasomotor Symptoms

This study has been terminated.
(Low drop-out rate and slow recruitment rate)
Sponsor:
Information provided by (Responsible Party):
Elizabeth Nedstrand, Ostergotland County Council
ClinicalTrials.gov Identifier:
NCT01488864
First received: December 6, 2011
Last updated: May 10, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Menopause
Hot Flashes
Behavioral: Applied Relaxation (AR)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Applied Relaxation for Vasomotor Symptoms in Postmenopausal Women - a Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Ostergotland County Council, Sweden:

Primary Outcome Measures:
  • Hot flashes average number and severity [ Time Frame: Baseline to 12 week after "start of treatment" ] [ Designated as safety issue: No ]
    The average number and severity of hot flashes/24 hours in self-registered diaries during the 12th week


Secondary Outcome Measures:
  • Hot flashes [ Time Frame: Baseline to 3 months after "end of treatment" ] [ Designated as safety issue: No ]
    The average number and severity of hot flashes per 24 hours after 3 months follow-up.

  • Hot flashes reduction of hot flashes [ Time Frame: Baseline to 3 months after "end of treatment" ] [ Designated as safety issue: No ]
    The reduction of hot flashes in women defined as responders. Responders are defined as women with ≥50% reduction of hot flashes.

  • Health Related Quality of Life [ Time Frame: Baseline to 3 months "end of treatment" ] [ Designated as safety issue: No ]
    The total score in the Women Health Questionnaire measured at 12th week and after 3 months follow-up.

  • Adverse Events [ Time Frame: Baseline to 3 months "end of treatment" ] [ Designated as safety issue: Yes ]
    Adverse events documented by means of using open-ended questions at each contact.

  • Salivary cortisol [ Time Frame: Baseline to 3 months after "end-of-treatment" ] [ Designated as safety issue: No ]
    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"


Enrollment: 60
Study Start Date: March 2007
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01488864

Locations
Sweden
University Hospital, Dept of Obstetrics and Gynecology
Linköping, Sweden, 5851 85
Sponsors and Collaborators
Elizabeth Nedstrand
Investigators
Principal Investigator: Elizabeth Nedstrand, Md, PhD Ostergotland CC, University Hospital Dept. of Obstetrics and Gynecology, 582 85 Linköping, Sweden
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Elizabeth Nedstrand, Md, PhD, Ostergotland County Council
ClinicalTrials.gov Identifier: NCT01488864     History of Changes
Other Study ID Numbers: LiÖ/AR-2007
Study First Received: December 6, 2011
Last Updated: May 10, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Ostergotland County Council, Sweden:
Hot flashes
Vasomotor symptoms
Menopause
Applied Relaxation
Health Related Quality of Life
Salivary cortisol

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014