- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07654712
Effectiveness of Education on Preventive Measures Against Acute Respiratory Tract Infections in School-Age Children
12 de junio de 2026 actualizado por: Aynur Aytekin Ozdemir, Istanbul Medeniyet University
Investigation of the Effectiveness of Education on Preventive Measures Against Acute Respiratory Tract Infections in School-Age Children: A Cluster Randomized Controlled Trial
This study aimed to evaluate the effectiveness of an animation video-supported education program on preventive measures against acute respiratory tract infections among first-grade primary school children.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
This study aimed to evaluate the effectiveness of an animation video-supported education program on preventive measures against acute respiratory tract infections among first-grade primary school children.
The study was conducted as a cluster randomized controlled trial in a public primary school in Istanbul, Türkiye.
Two first-grade classrooms were selected and randomly assigned to the intervention and control groups.
The intervention group received an animation video-supported education program on preventive measures against acute respiratory tract infections, while the control group received no education during the data collection period.
Outcomes were assessed at baseline and two weeks after completion of the intervention.
The primary outcomes included children's knowledge scores regarding preventive measures against respiratory tract infections, coughing/sneezing hygiene skill scores, and hand hygiene skill scores.
Tipo de estudio
Intervencionista
Inscripción (Actual)
48
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.
Ubicaciones de estudio
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Istanbul
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Istanbul, Istanbul, Turquía (Türkiye)
- Istanbul Medeniyet University
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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
- Niño
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Being enrolled in the first grade of the primary school where the study was conducted
- Being able to speak and understand Turkish
- Having written informed consent from a parent or legal guardian
- Being willing to participate in the study
Exclusion Criteria:
- Having an acute respiratory tract infection during data collection
- Having any chronic disease
- Having a physical or cognitive impairment that prevents communication, watching the educational materials, or completing the measurement tools
- Not having written informed consent from a parent or legal guardian
- Not being willing to participate in the study
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: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Animation Video-Supported Education Group
Participants in the intervention group received an animation video-supported education program on preventive measures against acute respiratory tract infections.
The program was delivered in a classroom setting over three weeks, in three sessions, with a total duration of 120 minutes.
The content included respiratory infection transmission, actions to be taken during illness, hand hygiene, coughing/sneezing etiquette, avoidance of touching the face, social distancing, and healthy lifestyle recommendations.
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The intervention consisted of an animation video-supported education program developed for first-grade primary school children.
The program included a 15-minute animation video, question-and-answer activities, demonstration and practice of coughing/sneezing etiquette, and demonstration and practice of hand hygiene using a handwashing station.
The education was delivered in three sessions over three weeks, with a total duration of 120 minutes.
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Sin intervención: Control Group
Participants in the control group did not receive any education on preventive measures against acute respiratory tract infections during the data collection period.
After completion of the post-test measurements, the education program was also provided to the control group.
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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 Knowledge Score on Preventive Measures Against Respiratory Tract Infections
Periodo de tiempo: Baseline and two weeks after completion of the intervention
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Children's knowledge regarding preventive measures against respiratory tract infections was assessed using the Knowledge Form on Preventive Measures Against Respiratory Tract Infections.
The form consists of 7 items.
Each correct answer is scored as 1 point and each incorrect answer is scored as 0 points.
Total scores range from 0 to 7, with higher scores indicating a higher level of knowledge.
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Baseline and two weeks after completion of the intervention
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Change in Coughing/Sneezing Hygiene Skill Score
Periodo de tiempo: Baseline and two weeks after completion of the intervention
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Children's coughing/sneezing hygiene skills were assessed using the Coughing/Sneezing Skill Checklist developed by the researchers.
The checklist evaluates appropriate protective behaviors during coughing or sneezing.
Items are scored as "performed" = 2 points, "partially performed" = 1 point, and "not performed" = 0 points.
Higher scores indicate better coughing/sneezing hygiene skills.
Skill performances were video-recorded and evaluated by two independent experts.
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Baseline and two weeks after completion of the intervention
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Change in Hand Hygiene Skill Score
Periodo de tiempo: Baseline and two weeks after completion of the intervention
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Children's hand hygiene skills were assessed using the Hand Hygiene Skill Checklist developed by the researchers.
The checklist consists of 12 items.
Each item is scored as "performed" = 2 points, "partially performed" = 1 point, and "not performed" = 0 points.
Higher scores indicate better hand hygiene skills.
Children demonstrated handwashing behavior using a standardized handwashing station, and performances were video-recorded and evaluated by two independent experts.
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Baseline and two weeks after completion of the intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Parent-Rated Independent Performance of Preventive Behaviors
Periodo de tiempo: Baseline and four weeks after completion of the intervention
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Parents evaluated children's independent performance of preventive behaviors against acute respiratory tract infections using a visual analog scale.
Higher scores indicate a higher level of independent performance of preventive behaviors.
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Baseline and four weeks after completion of the intervention
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Aynur Aytekin Özdemir, Professor, Istanbul Medeniyet 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 (Actual)
1 de noviembre de 2025
Finalización primaria (Actual)
16 de enero de 2026
Finalización del estudio (Actual)
16 de enero de 2026
Fechas de registro del estudio
Enviado por primera vez
12 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
12 de junio de 2026
Publicado por primera vez (Actual)
17 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025/11
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data will not be shared due to the involvement of child participants and confidentiality restrictions.
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. .