Infant Sleep SafetyNCT07771348
Animation-Supported Infant Sleep Safety Education
A study testing Animation-Supported Infant Sleep Safety Education in people with Infant Sleep Safety, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infant Sleep Safety
- What is being tested?
- Animation-Supported Infant Sleep Safety Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Medicana Sağlık Grubu Hastaneleri, Ümraniye Eğitim ve Araştırma Hastanesi, Prof. Dr. Süleyman Yalçın Şehir Hastanesi
Istanbul
About this study
Official title: 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.
- Conditions
- Infant Sleep Safety
- Being tested
- Animation-Supported Infant Sleep Safety Education
- Keywords
- Sleep safety, Safe sleep, Digital education, Pediatric nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animation-Supported Infant Sleep Safety EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Animation-Supported Infant Sleep Safety Education Group | Experimental | 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. Receives: Other: Animation-Supported Infant Sleep Safety Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Infant Sleep Safety Knowledge Scores
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.
Measured: Baseline, immediately after the intervention, and 1 month after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start15 Sep 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant Sleep SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru İkbal Gülenay , Bsc, Marmara University
- Investigators
- Çağrı Çövener Özçelik, Prof.Dr., Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771348
- Sponsor's protocol ID
- SLEEPSAFE-197
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Animation-Supported Education Developed for Infant Sleep Safety on Pediatric Nurses' Knowledge and Attitudes: A Mixed-Methods Study
- ClinicalTrials.gov ID
- NCT07771348
- Acronym / sponsor ID
- SLEEPSAFE-197
- Conditions
- Infant Sleep Safety
- Keywords
- Sleep safety, Safe sleep, Digital education, Pediatric nursing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Animation-Supported Infant Sleep Safety Education Group | Experimental | Other: Animation-Supported Infant Sleep Safety EducationPediatric 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animation-Supported Infant Sleep Safety EducationThis 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. | Other | Animation-Supported Infant Sleep Safety Education Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Çağrı Çövener Özçelik, Prof.Dr. principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animation-Supported Infant Sleep Safety Education in people with Infant Sleep Safety, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ebru İkbal Gülenay, BSc (+905313319283, ebruikbal02@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Infant Sleep Safety Knowledge Scores (time frame: Baseline, immediately after the intervention, and 1 month after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.