Applied Relaxation for Vasomotor Symptoms

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Menopause, Hot Flashes

Intervention / Treatment
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* Behavioral: Applied Relaxation (AR)


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Applied Relaxation (AR)<br> | Behavioral: Applied Relaxation (AR)<br>* 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.<br>|
| No Intervention: Untreated Control Group (CG)<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hot flashes average number and severity | 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 | 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 | 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 | 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 | Adverse events documented by means of using open-ended questions at each contact. | Baseline to 3 months end of treatment | 
| Salivary cortisol | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hot flashes, Vasomotor symptoms, Menopause, Applied Relaxation, Health Related Quality of Life, Salivary cortisol