Lifestyle changes to ease menopausal symptoms, sleep problems, and anxiety

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial compares a face-to-face structured lifestyle education program—covering physical activity, diet, sleep hygiene, and stress reduction—to standard clinical care in women aged 40 to 55 with menopausal symptoms. Participants are recruited from primary care and randomized 1:1 to intervention or control, with follow-up at 24 weeks. Outcomes are measured using the Menopause Rating Scale (MRS), Pittsburgh Sleep Quality Index (PSQI), and GAD-7 at baseline and Week 24. The study analyzes changes in symptom severity, sleep quality, and anxiety to determine the impact of the lifestyle program. All participants in the control group are offered the lifestyle education after the 24-week follow-up to ensure equal contribution to both arms.

Why it matters

Who can join: the full rules

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)

Where it's running

• Konya Beyhekim Training and Research Hospital
  Konya, Konya, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: İBRAHİM SOLAK, MD,AssocProf — Konya Beyhekim Training and Research Hospital
• Study coordinator: Ari̇fe Koçak, Md
• Email: arifekoccak@gmail.com
• Phone: +905050696295

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.