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Effects of Simulation Fidelity on Patient-Centered Care Competency, Empathy, and Learning Outcomes in Nursing Students: A Randomized Controlled Trial

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07637136
Enrollment
45
Registered
2026-06-09
Start date
2026-05-12
Completion date
2026-07-30
Last updated
2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Empathy, Nursing Education, Nursing Students, Patient-centered Care, Simulation Based Learning

Keywords

simulation fidelity, standardized patient, manikin simulation, nursing students, patient-centered care, empathy, learning self-confidence, debriefing, randomized controlled trial, nursing education Turkey

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALSimulation-Based Nursing Education

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.

Sponsors

Atılım University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Patient-Centered Care Competency Scale ScoreImmediately after the simulation sessionTotal score obtained from the Patient-Centered Care Competency Scale measuring nursing students' competency in providing patient-centered care
Jefferson Scale of Empathy ScoreImmediately after the simulation sessionTotal score obtained from the Jefferson Scale of Empathy measuring nursing students' empathy levels toward patients

Secondary

MeasureTime frameDescription
Student Satisfaction and Self-Confidence in Learning Scale ScoreImmediately after the simulation sessionTotal score obtained from the Student Satisfaction and Self-Confidence in Learning Scale measuring students' satisfaction and self-confidence following simulation
Perceived Reality of SimulationImmediately after the simulation sessionSemi-structured interview responses assessing students' perceived realism of the simulation experience

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORECEM OZGUL, PhD

Atilim University School of Health Sciences, Department of Nursing

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026