Applied Relaxation for Vasomotor Symptoms in Postmenopausal Women - a Randomized, Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Hot flashes average number and severity
Study Overview
Brief 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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Hot flashes(Baseline to 3 months after "end of treatment")
- Hot flashes reduction of hot flashes(Baseline to 3 months after "end of treatment")
- Health Related Quality of Life(Baseline to 3 months "end of treatment")
- Adverse Events(Baseline to 3 months "end of treatment")
- Salivary cortisol(Baseline to 3 months after "end-of-treatment")
Investigators
Elizabeth Nedstrand
Md, PhD
Ostergotland County Council, Sweden