PerimenopauseNCT07860645
Effect of Lifestyle Intervention on Menopausal Symptoms, Sleep Quality, and Anxiety in Peri- and Postmenopausal Women
A study testing Structured Lifestyle Education in people with Perimenopause and Postmenopause, run by Konya Beyhekim Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 55 years, women only
- Conditions the study is for
- Perimenopause, Postmenopause, Menopause
- What is being tested?
- Structured Lifestyle Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2026to 31 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Konya Beyhekim Training and Research Hospital
Konya, Konya, 42130
ARİFE KOÇAK, MD, +905050696295, arifekoccak@gmail.com
İBRAHİM SOLAK, MD
About this study
Official title: Evaluation of the Effect of Lifestyle Intervention on Menopausal Symptoms, Sleep Quality, and Anxiety in Perimenopausal and Postmenopausal Women: A Prospective, Randomized Controlled Study
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.
Read the detailed 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.
- Conditions
- Perimenopause, Postmenopause, Menopause
- Being tested
- Structured Lifestyle Education, Standard Care (in control arm)
- Keywords
- Menopausal Symptoms, Lifestyle Intervention, Sleep Quality, Anxiety, Primary Health Care, Randomized Controlled Trial
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Lifestyle EducationBehavioural
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)Other
Participants continue with standard routine care and health follow-up without the structured menopause lifestyle education during the first 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Intervention Group (Education First) | Experimental | Participants receive structured education on healthy lifestyle modifications during the menopausal transition, focusing on regular physical activity, dietary guidance, sleep hygiene, and stress reduction principles at baseline. Re-evaluation is performed face-to-face at 24 weeks. Receives: Behavioral: Structured Lifestyle Education |
| Control Group (Wait-list Control) | Active comparator | Participants receive standard clinical care without structured lifestyle education during the 24-week study period. Follow-up questionnaires are completed at 24 weeks, after which the healthy living educational information is provided. Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 24 weeks
Secondary outcomes (5)
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.
Measured: Baseline and 24 weeks
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.
Measured: Baseline and 24 weeks
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).
Measured: From baseline up to 24 weeks
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).
Measured: From baseline up to 24 weeks
Total Count of NSAID Prescriptions at 24 Weeks
Total number of non-steroidal anti-inflammatory drug (NSAID) prescriptions filled per participant over the 24-week follow-up period, assessed via electronic health records (e-Nabiz system)
Measured: From baseline up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start15 Oct 2026
- Primary completion15 May 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerimenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly allocated in a 1:1 ratio using a computer-generated block randomization list (block size of 4) via sequentially numbered, opaque, sealed envelopes into either the lifestyle intervention group or the control group.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konya Beyhekim Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, İbrahim Solak, Konya Beyhekim Training and Research Hospital
- Investigators
- İBRAHİM SOLAK, MD,AssocProf, Principal investigator, Konya Beyhekim Training and Research HospitalMUSTAFA YASİN ÖZTOPRAK, MD, Study director, Konya Beyhekim Training and Research HospitalARİFE KOÇAK, MD, Study director, Konya Beyhekim Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860645
- Sponsor's protocol ID
- 2026/65
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected during the study will not be shared publicly to protect participant privacy and confidentiality.