Effects of Simulation Fidelity on Patient-Centered Care Competency, Empathy, and Learning Outcomes in Nursing Students: A Randomized Controlled Trial
4 juin 2026 mis à jour par: Atılım University
The Effect of Perceived Patient Fidelity on Patient-Centered Care Competency, Empathy, Learning Self-Confidence, and Satisfaction in Simulation-Based Nursing Education: A Randomized Controlled Trial
This randomized controlled trial examines the effects of simulation fidelity on nursing students' patient-centered care competency, empathy, learning self-confidence, and satisfaction.
Participants will be randomly assigned to two groups: one group will practice with a standardized patient (actor) and the other with a manikin in a myocardial infarction scenario.
All sessions will follow the same structured simulation protocol including briefing, simulation, and debriefing phases.
The study aims to provide evidence on whether the type of simulated patient affects learning outcomes in nursing education.
Aperçu de l'étude
Statut
Actif, ne recrute pas
Les conditions
Intervention / Traitement
Description détaillée
Simulation-based education is widely used in nursing training to develop clinical competency in safe environments. The fidelity of simulation particularly whether a standardized patient or a manikin is used may influence the realism of the experience and subsequently affect learning outcomes. However, evidence comparing these two modalities on patient-centered care competency, empathy, and learning outcomes remains limited.
This study will be conducted at Atılım University School of Health Sciences Nursing Skills Laboratory in Ankara, Turkey. Second, third, and fourth-year nursing students who have completed the Internal Medicine Nursing course.
Eligible participants will be randomly assigned. The Standardized Patient Group (experimental) will practice a myocardial infarction nursing care scenario with a trained actor portraying the patient. The Manikin Group (active comparator) will perform the same scenario using a high-fidelity manikin. Both groups will follow an identical structured simulation protocol consisting of three phases: education and briefing (45 minutes), simulation (10-15 minutes), and debriefing (20 minutes).
A semi-structured perceived reality interview will be conducted with the standardized patient group following the simulation. Data will be collected using four instruments: the Patient-Centered Care Competency Scale, the Jefferson Empathy Scale, the Student Satisfaction and Self-Confidence in Learning Scale, and a Descriptive Information Form. All instruments will be administered immediately after the simulation session.
Each group will have at least 20 participants. Data will be analyzed using independent samples t-test or Mann-Whitney U test depending on normality of distribution.
Type d'étude
Interventionnel
Inscription (Estimé)
45
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Ankara, Turquie (Türkiye), 06830
- Atilim University, Faculty of Health Sciences, Nursing Skills Laboratory
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
Inclusion Criteria:
- Second, third, and fourth year undergraduate nursing students at Atılım University School of Health Sciences
- Successfully completed the Internal Medicine Nursing course
- Willingness to participate voluntarily and providing written informed consent
Exclusion Criteria:
- Did not complete the informed consent form
- Withdrawal of consent at any point during the study
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Standardized Patient Group
Participants in this group will perform a myocardial infarction nursing care scenario with a trained actor portraying the patient in a standardized patient simulation.
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A structured simulation protocol consisting of education and briefing (45 min), simulation (10-15 min), and debriefing (20 min) phases applied to both groups.
The standardized patient group uses a trained actor; the manikin group uses a high-fidelity manikin in an identical myocardial infarction scenario.
|
|
Comparateur actif: Manikin Group
Participants in this group will perform the same myocardial infarction nursing care scenario using a high-fidelity manikin simulation.
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A structured simulation protocol consisting of education and briefing (45 min), simulation (10-15 min), and debriefing (20 min) phases applied to both groups.
The standardized patient group uses a trained actor; the manikin group uses a high-fidelity manikin in an identical myocardial infarction 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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Patient-Centered Care Competency Scale Score
Délai: Immediately after the simulation session
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Total score obtained from the Patient-Centered Care Competency Scale measuring nursing students' competency in providing patient-centered care
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Immediately after the simulation session
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Jefferson Scale of Empathy Score
Délai: Immediately after the simulation session
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Total score obtained from the Jefferson Scale of Empathy measuring nursing students' empathy levels toward patients
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Immediately after the simulation session
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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 Score
Délai: Immediately after the simulation session
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Total score obtained from the Student Satisfaction and Self-Confidence in Learning Scale measuring students' satisfaction and self-confidence following simulation
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Immediately after the simulation session
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Perceived Reality of Simulation
Délai: Immediately after the simulation session
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Semi-structured interview responses assessing students' perceived realism of the simulation experience
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Immediately after the simulation session
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: ECEM OZGUL, PhD, Atilim University School of Health Sciences, Department of Nursing
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Kim J, Park JH, Shin S. Effectiveness of simulation-based nursing education depending on fidelity: a meta-analysis. BMC Med Educ. 2016 May 23;16:152. doi: 10.1186/s12909-016-0672-7.
- Britz V, Sterz J, Koch Y, Schreckenbach T, Stefanescu MC, Zinsser U, Verboket RD, Sommer K, Ruesseler M. Impact of simulated patient-based communication training vs. real patient-based communication training on empathetic behaviour in undergraduate students - a prospective evaluation study. BMC Med Educ. 2024 Aug 12;24(1):870. doi: 10.1186/s12909-024-05801-8.
- Karaçay, Pelin, and Hatice Kaya. "Simulasyonla Egitimde Kullanilan Ogrenci Memnuniyeti ve Ogrenmede Kendine Guven Olcegi'nin Turkce'ye Uyarlanmasi/The Turkish Adaptation of the Student Satisfaction and Self-Confidence Learning Scale Used in Simulation Education." Florence Nightingale Journal of Nursing 25.2 (2017): 95-104.
- Yanik, Aygül, and Sefa Saygili. "Validity and reliability of the Turkish version of jefferson scale of empathy for nursing students." Turkiye Klinikleri Journal of Medical Sciences 34.1 (2014): 111-119.
- Saygılı, Meltem, Ahmet Kar, and Özgür Uğurluoğlu. "Hasta merkezli bakım yetkinlik ölçeği: Türkçe geçerlilik ve güvenilirlik çalışması." Süleyman Demirel Üniversitesi Sağlık Bilimleri Dergisi 11.4 (2020): 416-426.
- Akpinar Soylemez B, Ozgul E, Akyol MA, Kucukguclu O. Effectiveness of the aged simulation suit on undergraduate nursing students' attitudes and empathy toward older adults: A systematic review and meta-analysis. Nurse Educ Pract. 2024 May;77:103990. doi: 10.1016/j.nepr.2024.103990. Epub 2024 May 7.
- Cant RP, Cooper SJ. Use of simulation-based learning in undergraduate nurse education: An umbrella systematic review. Nurse Educ Today. 2017 Feb;49:63-71. doi: 10.1016/j.nedt.2016.11.015. Epub 2016 Nov 22.
- Shin S, Park JH, Kim JH. Effectiveness of patient simulation in nursing education: meta-analysis. Nurse Educ Today. 2015 Jan;35(1):176-82. doi: 10.1016/j.nedt.2014.09.009. Epub 2014 Oct 29.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
12 mai 2026
Achèvement primaire (Estimé)
30 juillet 2026
Achèvement de l'étude (Estimé)
30 juillet 2026
Dates d'inscription aux études
Première soumission
4 juin 2026
Première soumission répondant aux critères de contrôle qualité
4 juin 2026
Première publication (Réel)
9 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
9 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- E-59394181-100-136938
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
Individual participant data will not be shared due to ethical and legal obligations regarding participant confidentiality.
Data were collected from undergraduate nursing students under informed consent agreements that do not include provisions for external data sharing.
All data are stored and processed in accordance with Turkish Personal Data Protection Law (KVKK - Law No. 6698).
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .