- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07771348
Animation-Supported Infant Sleep Safety Education
August 14, 2026 updated by: Ebru İkbal Gülenay , Bsc, Marmara University
The Effect of Animation-Supported Education Developed for Infant Sleep Safety on Pediatric Nurses' Knowledge and Attitudes: A Mixed-Methods Study
The aim of this research is to evaluate the effect of animation-supported sleep safety training on the knowledge and attitudes of pediatric nurses.
Sleep is one of the primary factors affecting an individual's cognitive development, learning capacity, and memory from the neonatal period through adulthood.
Regulating the sleep environment plays a critical role in establishing sleep architecture; for efficient and safe sleep, the environment must be free from external stimuli such as temperature extremes and light .
Ensuring standardization in infant sleep safety will both improve sleep quality and reduce the risk of sleep-related deaths, such as Sudden Infant Death Syndrome (SIDS).
Since prone sleeping positions and bed-sharing are the primary factors increasing the risk of sleep-related deaths, the American Academy of Pediatrics (AAP) recommends creating a separate sleep area and supine positioning as safe sleep practices However, various studies have demonstrated that families' and pediatric nurses' knowledge levels regarding SIDS vary based on cultural practices, that common practices in sleep safety need to be disseminated, and that current training is insufficient .
Nurses are the health professionals from whom families receive the most support during hospitalization and discharge processes.
Technological advancements bring rapid changes in healthcare practices, necessitating the integration of technology into education to train qualified health professionals.
Therefore, it is of great importance to train nurses with the most up-to-date and effective methods and to improve their knowledge and attitudes using digitally supported materials enriched with visual and auditory elements.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
115
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ebru İkbal Gülenay, BSc
- Phone Number: +905313319283
- Email: ebruikbal02@gmail.com
Study Locations
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Istanbul, Turkey (Türkiye)
- Medicana Sağlık Grubu Hastaneleri, Ümraniye Eğitim ve Araştırma Hastanesi, Prof. Dr. Süleyman Yalçın Şehir Hastanesi
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Pediatric nurse working in a neonatal intensive care unit, infant ward, or newborn nursery.
- No previous training on infant sleep safety.
- Willing to participate in the study and provide informed consent.
- Available to complete all study assessments.
Exclusion Criteria:
- Not working in the target clinical units.
- Previous participation in infant sleep safety training.
- Refusal to participate or provide informed consent.
- Incomplete participation in the data collection process.
- Administrative position.
- Temporary assignment or staff rotation during the study period.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Animation-Supported Infant Sleep Safety Education Group
Pediatric nurses will complete a baseline assessment before receiving animation-supported infant sleep safety education.
The intervention consists of a researcher-developed educational animation lasting approximately 3-4 minutes and covering safe sleep practices, prevention of sudden infant death syndrome (SIDS), safe sleep environments, sleep positioning, and risk reduction strategies.
Participants will complete an immediate post-test following the intervention and a follow-up assessment one month later to evaluate changes in knowledge and attitudes.
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This mixed-methods study aims to evaluate pediatric nurses' views, experiences, knowledge, and attitudes regarding animation-supported infant sleep safety education.
Quantitative and qualitative data will be collected from pediatric nurses working at Acıbadem Healthcare Group hospitals in Istanbul.
After obtaining informed consent, participants will complete a Nurse Descriptive Information Form and a Safe Sleep Knowledge Assessment Form as a pre-test.
Following the pre-test, nurses will receive a researcher-developed animation-supported educational intervention on infant sleep safety, lasting approximately 3-4 minutes.
Participants will then complete an immediate post-test.
To assess knowledge retention and the effectiveness of the intervention, the same assessment will be repeated one month later.
The study is designed to determine whether animation-supported education improves nurses' knowledge and attitudes regarding infant sleep safety.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Infant Sleep Safety Knowledge Scores
Time Frame: Baseline, immediately after the intervention, and 1 month after the intervention
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The change in pediatric nurses' knowledge regarding infant sleep safety will be assessed using the Safe Sleep Knowledge Assessment Form.
The form consists of 20 items.
Each correct answer is scored as 1 point, while incorrect and "I don't know" responses are scored as 0 points.
The total score ranges from 0 to 20, with higher scores indicating a higher level of knowledge regarding infant sleep safety.
The assessment will be administered at baseline, immediately after the intervention, and 1 month after the intervention.
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Baseline, immediately after the intervention, and 1 month after the intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Çağrı Çövener Özçelik, Prof.Dr., Marmara University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 15, 2026
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Study Registration Dates
First Submitted
August 11, 2026
First Submitted That Met QC Criteria
August 14, 2026
First Posted (Actual)
August 18, 2026
Study Record Updates
Last Update Posted (Actual)
August 18, 2026
Last Update Submitted That Met QC Criteria
August 14, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- SLEEPSAFE-197
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.