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.
None
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Parallel
Structured Lifestyle Education
BehavioralFace-to-face structured educational counseling covering regular physical activity recommendations, dietary guidance, sleep hygiene principles, and stress management strategies tailored for perimenopausal and postmenopausal women.
Standard Care (in control arm)
Other interventionParticipants continue with standard routine care and health follow-up without the structured menopause lifestyle education during the first 6 months.
Change from Baseline in Menopause Rating Scale (MRS) Total Score at 24 Weeks
Assessed using the Menopause Rating Scale (MRS), which evaluates somatic, psychological, and urogenital symptoms across 11 items. Each item is scored on a 5-point Likert scale (0=none to 4=very severe), yielding a total score ranging from 0 to 44. Higher scores reflect greater symptom severity. Change is defined as the score at 24 weeks minus the baseline score.
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at 24 Weeks
Subjective sleep quality over the previous month assessed using the Pittsburgh Sleep Quality Index (PSQI). The global score ranges from 0 to 21, where scores greater than 5 indicate poor sleep quality. Higher scores reflect worse sleep quality. Change is calculated as the score at 24 weeks minus the baseline score.
Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Score at 24 Weeks
Anxiety symptoms over the previous two weeks assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale. The total score ranges from 0 to 21, categorized as minimal (0-4), mild (5-9), moderate (10-14), and severe (15-21) anxiety. Higher scores indicate greater anxiety symptom severity. Change is defined as the score at 24 weeks minus the baseline score.
Rate of New Medication Initiation (Antidepressants or HRT) at 24 Weeks
Percentage of participants who were prescribed a new antidepressant or systemic hormone replacement therapy (HRT) during the 24-week follow-up period, assessed via electronic health records (e-Nabiz system).
Number of Emergency Department Visits at 24 Weeks
Total number of all-cause and symptom-related emergency department admissions per participant during the 24-week study period, extracted from electronic health records (e-Nabiz system).
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