← Back to all trials
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 \
Source: ClinicalTrials.gov (NCT07860645). StuddyBuddy aggregates publicly available trial information.