- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07678190
High-Fidelity Simulation in Vaccination Training
The Effect of High-fidelity Simulation on Childhood Vaccination Training in Nursing Students: A Randomized Controlled Trial
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
This randomized controlled trial evaluated the effectiveness of high-fidelity simulation (HFS) versus standard laboratory practice (SLP) on nursing students' knowledge, psychomotor skills, satisfaction, and self-confidence in childhood vaccination training. A total of 122 fourth-year nursing students were randomly assigned to HFS or SLP groups; 104 completed the study.
All participants received the same theoretical training on childhood immunization. The HFS group participated in a simulation scenario involving vaccine hesitancy, while the SLP group performed traditional laboratory-based practice on a manikin.
Knowledge was assessed using a pre-test, post-test at 1 hour, and a one-month follow-up test. Skills were evaluated immediately after the intervention. Satisfaction and self-confidence were also measured post-intervention.
The primary outcomes were knowledge and skill performance, while secondary outcomes included satisfaction and self-confidence. The study was conducted in accordance with ethical standards, and informed consent was obtained from all participants.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Zonguldak Province
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Kozlu, Zonguldak Province, Turquía (Türkiye), 67600
- Zonguldak Bulent Ecevit University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Fourth-year nursing students
- Voluntary participation
Exclusion Criteria:
- Did not complete post-tests
- Non-volunteering
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: High-Fidelity Simulation Group (HFS)
The HFS intervention was developed in accordance with INACSL Healthcare Simulation Standards and validated by six nursing experts.
All participants first received a standardized 100-minute childhood vaccination training consisting of theoretical instruction and laboratory practice.
The simulation session included a 10-minute briefing, a 20-minute high-fidelity scenario involving a vaccine-hesitant mother, and a 30-minute structured debriefing using the PEARLS framework.
During the simulation, students were required to assess parental concerns, provide education, safely administer vaccines, and complete documentation.
The debriefing process included reflection and analysis through structured phases to enhance learning outcomes.
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High-fidelity simulation-based training including a vaccine hesitancy scenario, structured briefing, simulation, and debriefing.
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Comparador activo: Standard Laboratory Practice Group (SLP)
The SLP group received the identical 100-minute theoretical and practical training session.
One week later, instead of a structured simulation, they participated in a 20-minute individual skills session in the nursing fundamentals laboratory.
Each student independently performed the vaccination procedure on a baby manikin and verbally described the parent education they would provide.
Following their session, each student also participated in an individual, video-assisted PEARLS debriefing focused on their technical performance and communication description.
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Traditional laboratory-based vaccination training using a manikin without a structured simulation scenario.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Childhood Immunization Knowledge Test (CIKT)
Periodo de tiempo: Baseline, 1 hour after training, and 1 month after training
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A 10-item multiple-choice test developed by the researchers based on national guidelines and literature.
Each correct answer is scored as 10 points.
Total scores range from 0 to 100, with higher scores indicating greater knowledge of childhood immunization.
Expert validation was obtained, and the KR-20 reliability coefficient was 0.93.
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Baseline, 1 hour after training, and 1 month after training
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Pediatric Intramuscular Vaccination Administration Checklist (PIVAC)
Periodo de tiempo: 1 hour after training
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Items are scored from 0 (not performed) to 2 (performed).
Total scores range from 0 to 40, with higher scores indicating better pediatric intramuscular vaccination administration skills.
The checklist demonstrated expert validity and a Cronbach's alpha of 0.90.
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1 hour after training
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Student Satisfaction and Self-Confidence in Learning Scale (SCLS)
Periodo de tiempo: 1 hour after training
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A validated 12-item, 5-point Likert scale with two subscales (Satisfaction and Self-Confidence).
Total scores range from 12 to 60, with higher scores indicating greater satisfaction and self-confidence in learning.
In this study, Cronbach's alpha was 0.96 for the satisfaction subscale, 0.94 for the self-confidence subscale, and 0.96 for the total scale.
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1 hour after training
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Simulation Design Scale (SDS)
Periodo de tiempo: 1 hour after training
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The Simulation Design Scale consists of 20 items rated on a 5-point Likert scale.
Total scores range from 20 to 100, with higher scores indicating a more positive evaluation of the simulation design.
Cronbach's alpha was 0.98.
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1 hour after training
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Nelson, B., Ridgway, J., Brown, A., Anthamatten, A., Hall, E., & McClure, N. (2025). Interactive simulation for addressing vaccine hesitancy in nurse practitioner education. Clinical Simulation in Nursing,102, 101719. https://doi.org/10.1016/j.ecns.2025.101719
- Hekel BE, Dugger J, Pullis BR, Cron S, Edwards AP. Vaccine Hesitancy: Developing Competency in Nursing Students Through Simulation. Nurse Educ. 2024 Mar-Apr 01;49(2):E62-E67. doi: 10.1097/NNE.0000000000001505. Epub 2023 Sep 1.
- Costa RRO, Medeiros SM, Martins JCA, Coutinho VRD, Araujo MS. Effectiveness of simulation in teaching immunization in nursing: a randomized clinical trial. Rev Lat Am Enfermagem. 2020 Jun 19;28:e3305. doi: 10.1590/1518-8345.3147.3305. eCollection 2020.
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
Otros números de identificación del estudio
- 205926
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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