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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
115

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • Medicana Sağlık Grubu Hastaneleri, Ümraniye Eğitim ve Araştırma Hastanesi, Prof. Dr. Süleyman Yalçın Şehir Hastanesi

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Animation-Supported Infant Sleep Safety Education
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Infant Sleep Safety Knowledge Scores
Time Frame: Baseline, immediately after the intervention, and 1 month after the intervention
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.
Baseline, immediately after the intervention, and 1 month after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marmara University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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