An interventional study of Sleep Hygiene Education in Insomnia and Depressive Symptoms, sponsored by Ankara Yildirim Beyazıt University. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 45 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by Ankara Yildirim Beyazıt University · Not applicable, Interventional, and Treatment
This study aims to evaluate the effects of sleep hygiene education on sleep quality and depression in women during menopause. Women will be randomly assigned to either an education group or a control group. The education group will receive training based on the Information-Motivation-Behavioral Skills (IMB) Model. Sleep quality and depression levels will be measured before and after the education. The results will provide insight into whether sleep hygiene education can improve sleep quality and reduce depression in menopausal women.
This study aims to evaluate the effects of sleep hygiene education on sleep quality and depression in menopausal women. The study will be conducted in two phases. In the first phase, a menopause-specific sleep quality scale will be developed to assess sleep habits, nighttime awakenings, sleep disruptors, and sleep hygiene behaviors in this population. In the second phase, participants will be randomly assigned to either a control group or an intervention group receiving sleep hygiene education based on the Information-Motivation-Behavioral Skills (IMB) Model. Sleep quality and depression levels will be measured before and after the intervention using validated psychological and physiological assessments. Daily sleep tracking logs will also be used to monitor adherence and intervention effectiveness. The findings will provide insight into whether sleep hygiene education can improve sleep quality and reduce depression among menopausal women, and will serve as a resource for developing nursing interventions and informing health policies.
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
This study's planned enrollment of 500 is above the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Ankara Yildirim Beyazıt University is the lead sponsor of 241 studies on the registry; 54 are open to participants now.
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Exclusion Criteria:
Participants will receive sleep hygiene education based on the Information-Motivation-Behavioral Skills (IMB) Model. Sleep habits, routines, and behaviors to improve sleep quality will be taught. Sleep quality and depression will be measured before and after the intervention, and participants will maintain daily sleep logs.
Behavioral: Sleep Hygiene Education
Participants will receive standard care without additional sleep hygiene education. Sleep quality and depression will be measured at the same time points as the intervention group.
Education based on the IMB Model targeting sleep habits, routines, and sleep hygiene behaviors to improve sleep quality.
Sleep Quality
Change in sleep quality measured using the Menopause-Specific Sleep Quality Scale before and after the sleep hygiene education intervention.
Time frame: Baseline and 10 weeks after intervention
Plan to share: Yes — IPD Sharing Plan: Yes. De-identified IPD (protocol, SAP, and raw outcome datasets for MSSQS and BDI) will be shared with researchers submitting a methodologically sound proposal. Data will be available starting 9 months post-publication and for 36 months. Access requires a signed Data Access Agreement (DAA). Contact the Principal Investigator at [busrakaragol22@gmail.com] for proposals.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Start Date9 months following article publication End Date36 months following article publication
Access criteria: Access is limited to qualified external researchers who submit a methodologically sound research proposal to the Principal Investigator at [busrakaragol22@gmail.com]. Researchers will access de-identified IPD (including MSSQS/BDI data, Protocol, SAP, and Analytic Code). Access is conditional upon two requirements: Execution of a Data Access Agreement (DAA). Provision of ethical approval (IRB/IEC) for secondary analysis from the requester's institution. Data is strictly for non-commercial use.
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