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

NCT07860645 · tracked via the Priya Life Science Turkey tracker

Sponsor

Konya Beyhekim Training and Research Hospital

Phase

Not applicable

Started

2026-10-15

Last updated

2026-10-06

Condition(s) studied

PerimenopausePostmenopauseMenopause

Investigational drug(s) / intervention(s)

Structured Lifestyle EducationStandard Care (in control arm)

Structured Lifestyle Education: Face-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): Participants continue with standard routine care and health follow-up without the structured menopause lifestyle education during the first 6 months.

Study 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

Sex

FEMALE

Min age

40 Years

Max age

55 Years

Healthy volunteers

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)

Primary outcome measure(s)

Change from Baseline in Menopause Rating Scale (MRS) Total Score at 24 Weeks — Baseline and 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.

Trial sites (1)

Facility	City	Region	Status
Konya Beyhekim Training and Research Hospital	Konya	Konya

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07860645 on ClinicalTrials.gov ↗ ← All trials in Turkey