- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07771348
Animation-Supported Infant Sleep Safety Education
14 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
115
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Ebru İkbal Gülenay, BSc
- Número de teléfono: +905313319283
- Correo electrónico: ebruikbal02@gmail.com
Ubicaciones de estudio
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Istanbul, Turquía (Türkiye)
- Medicana Sağlık Grubu Hastaneleri, Ümraniye Eğitim ve Araştırma Hastanesi, Prof. Dr. Süleyman Yalçın Şehir Hastanesi
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Infant Sleep Safety Knowledge Scores
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Çağrı Çövener Özçelik, Prof.Dr., Marmara University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
15 de septiembre de 2026
Finalización primaria (Estimado)
1 de mayo de 2027
Finalización del estudio (Estimado)
1 de mayo de 2027
Fechas de registro del estudio
Enviado por primera vez
11 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
14 de agosto de 2026
Publicado por primera vez (Actual)
18 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
14 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- SLEEPSAFE-197
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .