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Recruiting NCT07860645

Effect of Lifestyle Intervention on Menopausal Symptoms, Sleep Quality, and Anxiety in Peri- and Postmenopausal Women

Conditions: Perimenopause, Postmenopause, Menopause

Sex: Female
Ages: 40 Years – 55 Years
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Konya Beyhekim Training and Research Hospital

Location: Konya Beyhekim Training and Research Hospital Konya Konya

Summary

Menopause is a biological process characterized by the permanent cessation of menstruation, often accompanied by vasomotor symptoms, sleep disturbances, anxiety, and impaired quality of life. In primary healthcare settings, structured lifestyle interventions offer low-cost, safe, and sustainable non-pharmacological management strategies. The objective of this prospective, randomized controlled trial is to evaluate whether a structured lifestyle educational intervention leads to significant improvements in menopausal symptom severity, sleep quality, and anxiety levels compared with a control group receiving routine clinical care among perimenopausal and postmenopausal women aged 40 to 55 years. Primary and secondary outcomes are evaluated using the Menopause Rating Scale (MRS), Pittsburgh Sleep Quality Index (PSQI), and Generalized Anxiety Disorder-7 (GAD-7) at baseline and at 24 weeks.

Eligibility Criteria

Inclusion Criteria: Female patients aged 40 to 55 years presenting to the Educational Family Health Center Categorized into one of the defined reproductive stages: late perimenopause, early postmenopause (0-5 years), or late postmenopause (\>5 years) Reporting clinically significant complaints in at least one key menopausal domain: hot flashes/night sweats, sleep problems, or mood changes (anxiety, irritability, depressive mood) Baseline Menopause Rating Scale (MRS) total score between 9 and 31 (inclusive) Literate and capable of comprehending and completing study questionnaires Accessible for the 24-week follow-up evaluation History of compensated chronic disease (e.g., controlled diabetes mellitus, hypertension, atherosclerotic cardiovascular disease, hyperlipidemia) Provision of written informed consent Exclusion Criteria: Age younger than 40 or older than 55 years History of hysterectomy or bilateral oophorectomy Severe cognitive impairment or inability to complete questionnaires Inability or refusal to provide written informed consent Previously diagnosed severe psychiatric illness (e.g., psychotic disorders, bipolar disorder) Baseline Menopause Rating Scale (MRS) total score \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07860645). StuddyBuddy aggregates publicly available trial information.