Applied Relaxation for Vasomotor Symptoms

Elizabeth Nedstrand

Status: Terminated

Conditions: Menopause; Hot Flashes

Treatments: Behavioral: Applied Relaxation (AR)

Study type: Interventional

Funder types: Other

Identifiers

NCT01488864

LiÖ/AR-2007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Applied Relaxation (AR)

Experimental group

Treatment:

Behavioral: Applied Relaxation (AR)

Untreated Control Group (CG)

No Intervention group

Description:

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.