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

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.

Study Overview

• Status: Recruiting
• Conditions: Insomnia; Depressive Symptoms
• Intervention / Treatment: Behavioral: Sleep Hygiene Education

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Busra Karagol; Phone Number: +90 544 574 56 95; Email: busrakaragol22@gmail.com

Study Locations

• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye)
    • Recruiting
    • ANKARA ATATURK SANATORİUM TRAİNİNG AND RESEARCH HOSPITAL
    • Contact: Ankara Atatürk Sanatorium Training and Research Hospital; Phone Number: +90 544 574 56 95; Email: busrakaragol22@gmail.com
    • Contact: Aytebn ARIÖZ DÜZGÜN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep Hygiene Education; 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; Education based on the IMB Model targeting sleep habits, routines, and sleep hygiene behaviors to improve sleep quality.
No Intervention: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ankara Yildirim Beyazıt University
• Investigators: Study Director: Ayten ARIÖZ DÜZGÜN, Ankara Yildirim Beyazıt University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Depression; Randomized controlled trial; Menopause; Sleep quality; Sleep hygiene; Women's health
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Behavior; Health Behavior; Depression; Sleep Initiation and Maintenance Disorders; Sleep Hygiene
• Other Study ID Numbers: 20.11.2025-09/1541

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Start Date9 months following article publication End Date36 months following article publication

IPD Sharing 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 Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No