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
| Registry | NCT07637136 |
|---|---|
| Status | Active not recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, other |
| Enrollment | 45 (Estimated) |
| Sponsor | Atılım University (Other) |
| Conditions | Nursing Education, Simulation Based Learning, Patient-centered Care, Empathy, Nursing Students |
| Interventions | Simulation-Based Nursing Education (Behavioral) |
| Dates | start 2026-05-12, primary completion 2026-07-30 (estimated), completion 2026-07-30 (estimated), first posted 2026-06-09, last updated 2026-06-09 |
| Locations | 1 site in Turkey (Türkiye) |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Standardized Patient Group | Experimental | Behavioral: Simulation-Based Nursing Education | Participants in this group will perform a myocardial infarction nursing care scenario with a trained actor portraying the patient in a standardized patient simulation. |
| Manikin Group | Active comparator | Behavioral: Simulation-Based Nursing Education | Participants in this group will perform the same myocardial infarction nursing care scenario using a high-fidelity manikin simulation. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Atilim University, Faculty of Health Sciences, Nursing Skills Laboratory | Ankara | Turkey (Türkiye) |