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NCT Number: NCT07637136

Effects of Simulation Fidelity on Patient-Centered Care Competency, Empathy, and Learning Outcomes in Nursing Students: 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atilim University, Faculty of Health Sciences, Nursing Skills Laboratory

Ankara, 06830, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simulation-Based Nursing Education

Behavioral

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.

Primary outcomes

  1. Patient-Centered Care Competency Scale Score

    Time frame: Immediately after the simulation session

    Total score obtained from the Patient-Centered Care Competency Scale measuring nursing students' competency in providing patient-centered care

  2. Jefferson Scale of Empathy Score

    Time frame: Immediately after the simulation session

    Total score obtained from the Jefferson Scale of Empathy measuring nursing students' empathy levels toward patients

Secondary outcomes

  1. Student Satisfaction and Self-Confidence in Learning Scale Score

    Time frame: Immediately after the simulation session

    Total score obtained from the Student Satisfaction and Self-Confidence in Learning Scale measuring students' satisfaction and self-confidence following simulation

  2. Perceived Reality of Simulation

    Time frame: Immediately after the simulation session

    Semi-structured interview responses assessing students' perceived realism of the simulation experience

Sponsors and collaborators

Lead sponsor

Atılım University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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