IMB-Based Sleep Hygiene Education for Menopausal Women: Effects on Sleep Quality and Depression
The Effect of Information, Motivation, Behavioral Skills (IMB) Model-Based Sleep Hygiene Education on Sleep Quality and Depression Level in Menopausal Women: A Methodological and Experimental Study
1 other identifier
interventional
500
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2025
CompletedFirst Posted
Study publicly available on registry
December 23, 2025
CompletedStudy Start
First participant enrolled
January 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedDecember 23, 2025
December 1, 2025
2 months
December 10, 2025
December 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sleep Quality
Change in sleep quality measured using the Menopause-Specific Sleep Quality Scale before and after the sleep hygiene education intervention.
Baseline and 10 weeks after intervention
Study Arms (2)
Sleep Hygiene Education
EXPERIMENTALParticipants 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.
Control
NO INTERVENTIONParticipants 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.
Interventions
Education based on the IMB Model targeting sleep habits, routines, and sleep hygiene behaviors to improve sleep quality.
Eligibility Criteria
You may qualify if:
- Being in menopause
- Being between 40 and 60 years of age
- Having a low sleep quality score according to the Menopause-Specific Sleep Quality Scale.
- Being willing to participate in the study.
- Having no physical or mental disabilities that would hinder communication.
- Having technology (smartphone, tablet, or computer) with internet access and the ability to participate in online training.
You may not qualify if:
- Having a history of receiving psychological support.
- Having been diagnosed with a chronic psychiatric illness (previously diagnosed depression, anxiety disorder, etc.).
- Having a neurological or chronic systemic illness that may affect sleep quality.
- Being treated for a sleep disorder (receiving medication or psychotherapy).
- Receiving hormone replacement therapy (HT).
- Having received sleep hygiene training/therapy within the last 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ankara Atatürk Sanatorium Training and Research Hospital
Ankara, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ayten ARIÖZ DÜZGÜN
Ankara Yildirim Beyazıt University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2025
First Posted
December 23, 2025
Study Start
January 1, 2026
Primary Completion
March 1, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
December 23, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, 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.
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.