NCT07637136

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
May 2026Jul 2026

Study Start

First participant enrolled

May 12, 2026

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

June 4, 2026

Last Update Submit

June 4, 2026

Conditions

Simulation Based LearningPatient-centered CareEmpathyNursing EducationNursing Students

Keywords

simulation fidelitystandardized patientmanikin simulationnursing studentspatient-centered careempathylearning self-confidencedebriefingrandomized controlled trialnursing education Turkey

Outcome Measures

Primary Outcomes (2)

  • Patient-Centered Care Competency Scale Score

    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

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

    Immediately after the simulation session

Secondary Outcomes (2)

  • Student Satisfaction and Self-Confidence in Learning Scale Score

    Immediately after the simulation session

  • Perceived Reality of Simulation

    Immediately after the simulation session

Study Arms (2)

Standardized Patient Group

EXPERIMENTAL

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

Manikin Group

ACTIVE COMPARATOR

Participants in this group will perform the same myocardial infarction nursing care scenario using a high-fidelity manikin simulation.

Behavioral: Simulation-Based Nursing Education

Interventions

Simulation-Based Nursing EducationBEHAVIORAL

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.

Manikin GroupStandardized Patient Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Did not complete the informed consent form
  • Withdrawal of consent at any point during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atilim University, Faculty of Health Sciences, Nursing Skills Laboratory

Ankara, 06830, Turkey (Türkiye)

Location

Related Publications (8)

  • 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.

    PMID: 27215280RESULT

  • 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.

    PMID: 39134984RESULT

  • 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.

    RESULT

  • 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.

    RESULT

  • 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.

    RESULT

  • 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.

    PMID: 38733958RESULT

  • 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.

    PMID: 27902949RESULT

  • 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.

    PMID: 25459172RESULT

Related Links

Study Officials

  • ECEM OZGUL, PhD

    Atilim University School of Health Sciences, Department of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2026

First Posted

June 9, 2026

Study Start

May 12, 2026

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

July 30, 2026

Last Updated

June 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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).

Locations

TU(1)