Menopause Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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