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

June 4, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06830
        • Atilim University, Faculty of Health Sciences, Nursing Skills Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: Simulation-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.
Active Comparator: Manikin Group
Participants in this group will perform the same myocardial infarction nursing care scenario using a high-fidelity manikin simulation.
Behavioral: Simulation-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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Immediately after the simulation session
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
Immediately after the simulation session

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Immediately after the simulation session
Perceived Reality of Simulation
Time Frame: Immediately after the simulation session
Semi-structured interview responses assessing students' perceived realism of the simulation experience
Immediately after the simulation session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Atılım University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: ECEM OZGUL, PhD, Atilim University School of Health Sciences, Department of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 12, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E-59394181-100-136938

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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