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IMB-Based Sleep Hygiene Education for Menopausal Women: Effects on Sleep Quality and Depression

NCT ID: NCT07299903

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Insomnia Depressive Symptoms

Keywords

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Menopause Sleep quality Sleep hygiene Depression Women's health Randomized controlled trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Sleep Hygiene Education

Intervention Type BEHAVIORAL

Education based on the IMB Model targeting sleep habits, routines, and sleep hygiene behaviors to improve sleep quality.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sleep Hygiene Education

Education based on the IMB Model targeting sleep habits, routines, and sleep hygiene behaviors to improve sleep quality.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ankara Yildirim Beyazıt University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ayten ARIÖZ DÜZGÜN

Role: STUDY_DIRECTOR

Ankara Yildirim Beyazıt University

Locations

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Ankara Atatürk Sanatorium Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Busra Karagol

Role: CONTACT

Phone: +90 544 574 56 95

Email: [email protected]

Facility Contacts

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Ankara Atatürk Sanatorium Training and Research Hospital

Role: primary

Aytebn ARIÖZ DÜZGÜN

Role: backup

Other Identifiers

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20.11.2025-09/1541

Identifier Type: -

Identifier Source: org_study_id