Overview
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.
Description
Background and Objective:
In perimenopausal and postmenopausal women aged 40-55 presenting to primary care, this study evaluates the impact of a structured lifestyle modification program on menopausal symptoms, sleep quality, and anxiety compared with a control group.
Methods and Design:
This prospective, parallel-group, randomized controlled trial is conducted at Selcuklu Ardicli Educational Family Health Center (Units 218, 225, 239, 240) affiliated with Konya Beyhekim Training and Research Hospital.
Eligible women aged 40-55 years with baseline MRS scores between 9 and 31 will be randomized in a 1:1 allocation ratio using a computer-generated block randomization list (block size of 4) via sequentially numbered, opaque, sealed envelopes:
Intervention Group: Receives face-to-face structured educational counseling covering physical activity recommendations, dietary guidance, sleep hygiene, and stress reduction principles at baseline. Re-evaluation is performed face-to-face at 24 weeks.
Control Group: Receives standard clinical care without structured lifestyle education. At the end of the 24-week follow-up and completion of final questionnaires, the same lifestyle education is provided to ensure equal contribution to both groups.
Outcome Assessments:
Questionnaires administered at baseline and Week 24:
Menopause Rating Scale (MRS) for somatic, psychological, and urogenital symptoms.
Pittsburgh Sleep Quality Index (PSQI) for subjective sleep quality over the previous month.
Generalized Anxiety Disorder-7 (GAD-7) for anxiety symptoms over the past two weeks.
In addition, national electronic health records (e-Nabız) will be reviewed at Month 6 for new antidepressant initiation, systemic hormone replacement therapy initiation, prescription counts of non-steroidal anti-inflammatory drugs (NSAIDs), and emergency department visits.
Sample Size Calculation:
Calculated using G\*Power 3.1.9.4 with repeated measures ANOVA (within-between interaction; effect size f=0.20, alpha=0.05, power=0.95, 2 groups, 2 measurements, correlation=0.50), yielding a minimum of 84 participants. Accounting for a 10% dropout rate, a total of 100 participants (50 intervention group, 50 control group) will be enrolled.
Eligibility
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 \<9 or ≥32
History of decompensated chronic disease (e.g., uncontrolled hypertension, unstable cardiovascular disease, decompensated diabetes mellitus)
