- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07678190
High-Fidelity Simulation in Vaccination Training
The Effect of High-fidelity Simulation on Childhood Vaccination Training in Nursing Students: A Randomized Controlled Trial
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Zonguldak Province
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Kozlu, Zonguldak Province, Turquie (Türkiye), 67600
- Zonguldak Bulent Ecevit University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Fourth-year nursing students
- Voluntary participation
Exclusion Criteria:
- Did not complete post-tests
- Non-volunteering
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Childhood Immunization Knowledge Test (CIKT)
Délai: 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)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Student Satisfaction and Self-Confidence in Learning Scale (SCLS)
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 205926
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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