Cardiopulmonary Resuscitation and Choking Management Education for Caregivers of Infants Under 1 Year: Comparison Between Practical Workshop and Informational Leaflet
Effectiveness of an Educational Intervention on Basic Life Support for Caregivers of Infants Under 1 Year: a Crossover Clinical Trial
Objective: to evaluate the effectiveness of an educational workshop versus standard information in improving knowledge and perceived self-efficacy in basic life support.
Study Design: randomized crossover clinical trial with two intervention periods and a one-month washout.
Methods:
- Participants: Parents, caregivers, or legal guardians of infants under 6 months of age attending well-child check-ups at three primary care centers in Cantabria.
- Interventions: Participants will be randomly assigned to two sequences: group AB will first receive intervention A (an explained information leaflet) followed by intervention B (a theoretical-practical workshop); group BA will follow the reverse order.
- Randomization: Allocation sequence concealed using sequentially numbered, opaque sealed envelopes.
- Blinding: Outcome assessors were blinded to group allocation; participants and those delivering the interventions were not.
- Implications for practice: Planned implementation of practical workshops in childcare to enhance family responses to life-threatening pediatric emergencies.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
Cantabria
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Santander, Cantabria, España, 39008
- Marques De Valdecilla University Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion criteria:
- Being a parent or close relative of an infant under 6 months of age
- Belonging to the assigned population of one of the selected primary care centers (Bezana, El Alisal, Puente San Miguel)
- Providing written informed consent
Exclusion criteria:
-Previous experience or formal training in pediatric cardiopulmonary resuscitation (accredited courses or undergraduate training)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Group AB: Explained information sheet + theoretical-practical workshop
Delivery and explanation during consultation of an informational sheet on management of choking in infants under 1 year, based on ERC guidelines.
The intervention includes minimal theoretical instruction without mannequin practice.
After the explanation, the date for the practical workshop is provided.
|
It consisted of the delivery and brief explanation of an informational sheet on how to respond to a choking episode in infants, based on the current recommendations of the European Resuscitation Council (ERC).
This information is part of the standard content provided to families during the six-month check-up at Health Centers, within the framework of the Child Health Program of the Autonomous Community of Cantabria.
It should be noted that the sheet focuses exclusively on actions to take in case of choking, as the program does not include instruction on CPR.
It consisted of a training workshop. Each session lasted 60 to 90 minutes, with a maximum of 13 participants per group, and was conducted by three pediatric resident nurses who remained constant across all sessions to ensure consistency. The workshop was structured in two parts: -Theoretical: The content was organized into two blocks: Choking: most common causes, primary prevention, and management guidelines for a choking episode in infants. Pediatric CPR: identification of cardiopulmonary arrest (CPA), CPR sequence and guidelines, and appropriate moments to alert emergency services. -Practical: Participants were divided into three subgroups, each guided by a nurse and using a pediatric simulation manikin. Each participant individually completed a practical case of choking that progressed to CPA. |
|
Comparador activo: Group BA: theoretical-practical workshop + explanation of informational sheet
60-90 minute workshop with theoretical and practical sections.
It includes a presentation of key concepts and individual practice using a pediatric manikin simulating choking and cardiopulmonary arrest, following ERC recommendations.
Each participant performs the practical cases guided by pediatric resident nurses.
After completing the workshop, the date for the explanation of the informational sheet is indicated.
|
It consisted of the delivery and brief explanation of an informational sheet on how to respond to a choking episode in infants, based on the current recommendations of the European Resuscitation Council (ERC).
This information is part of the standard content provided to families during the six-month check-up at Health Centers, within the framework of the Child Health Program of the Autonomous Community of Cantabria.
It should be noted that the sheet focuses exclusively on actions to take in case of choking, as the program does not include instruction on CPR.
It consisted of a training workshop. Each session lasted 60 to 90 minutes, with a maximum of 13 participants per group, and was conducted by three pediatric resident nurses who remained constant across all sessions to ensure consistency. The workshop was structured in two parts: -Theoretical: The content was organized into two blocks: Choking: most common causes, primary prevention, and management guidelines for a choking episode in infants. Pediatric CPR: identification of cardiopulmonary arrest (CPA), CPR sequence and guidelines, and appropriate moments to alert emergency services. -Practical: Participants were divided into three subgroups, each guided by a nurse and using a pediatric simulation manikin. Each participant individually completed a practical case of choking that progressed to CPA. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in the score of theoretical knowledge on pediatric basic life support (BLS) and choking management.
Periodo de tiempo: Immediately after each intervention and 1 month after the second intervention.
|
Theoretical knowledge will be assessed using an ad hoc 11-item multiple-choice questionnaire, specifically developed for this study due to the lack of validated scales aimed at caregivers of infants under one year of age in this field.
The questionnaire was based on the recommendations of the European Resuscitation Council (ERC).
Each correct answer will be awarded 1 point, with a total score ranging from 0 to 11.
The outcome will be expressed as the change in score from baseline (pretest) to post-intervention assessments.
|
Immediately after each intervention and 1 month after the second intervention.
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. doi: 10.1037//0033-295x.84.2.191. No abstract available.
- Larrea J. Estadística de atragantamientos en España 2022 - OPRA. 2024
- Djakow J, Turner NM, Skellett S, Buysse CMP, Cardona F, de Lucas N, et al.; ERC Paediatric Life Support Writing Group Collaborators. European Resuscitation Council Guidelines 2025: Paediatric Life Support. Resuscitation. 2025;215(Suppl 1):110767
- McCarrison R, Ren D, Woomer GR, Cassidy B. Evaluation of a Self-Instructional CPR Program for Parents With Children Enrolled in Community Swim Lessons. J Pediatr Health Care. 2017 May-Jun;31(3):314-319. doi: 10.1016/j.pedhc.2016.09.006. Epub 2016 Oct 19.
- Perkins GD, Graesner JT, Semeraro F, Olasveengen T, Soar J, Lott C, et al. European Resuscitation Council Guidelines 2021: Executive summary. Resuscitation. 2021;161:1-60
- Tiscar-Gonzalez V, Gastaldo D, Moreno-Casbas MT, Peter E, Rodriguez-Molinuevo A, Gea-Sanchez M. [Presence of relatives during cardiopulmonary resuscitation: Perspectives of health professionals, patients and family in the Basque Country]. Aten Primaria. 2019 May;51(5):269-277. doi: 10.1016/j.aprim.2017.12.002. Epub 2018 Mar 20. Spanish.
- Camejo M, Noboa M, Stegmann T, Moraes Morelli D. Conocimiento sobre soporte vital básico en padres de niños menores de 5 años: estudio de corte transversal. NURE Investig. 2022;(117):7.
- Ramos Santana N, Marrero Pérez CL, Martín Fumero L, Domínguez Suárez E, Alcocer Díaz L, Martín Pulido S, et al. Resultados de los cursos de reanimación cardiopulmonar básica para los padres de niños ingresados en una Unidad de Cuidados Intensivos Neonatales. Canarias Pediátrica.2013;37(1):10-3.
- Mejías AM. Reanimación cardiopulmonar básica y avanzada pediátrica. En: Protocolos diagnósticos y terapéuticos en pediatría. Madrid: Asociación Española de Pediatría; 2020. p. 31-48.
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Heridas y Lesiones
- Procesos Patológicos
- Enfermedades de las vías respiratorias
- Trastornos de la respiración
- Insuficiencia respiratoria
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Adherencia y Cumplimiento del Tratamiento
- Comportamiento de salud
- Cumplimiento del paciente
- Aceptación del paciente de la atención médica
- Intervenciones de adherencia
- Adherencia a la medicación
- Aspiración Respiratoria
- Obstrucción de la vía aerea
- Cuerpos extraños
- Educación para la salud
Otros números de identificación del estudio
- 2025.404
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Anonymized individual participant data, including sociodemographic variables, responses from knowledge and self-efficacy questionnaires, and intervention sequence, will be available for research purposes. A data dictionary describing the coding and definition of each variable will also be provided.
Access to the data will be granted upon request, following submission of a research proposal and signing a data use agreement to ensure compliance with data protection regulations. The data will be available starting 6 months after the publication of the main study results.
Información sobre medicamentos y dispositivos, documentos del estudio
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