NCT07757750

Brief Summary

This study aims to examine the effect of a schizophrenia scenario-based simulation on nursing students' knowledge, empathy, and caregiving competence. The study uses a single-group pre-test/post-test (quasi-experimental) design. Nursing students enrolled in a Mental Health and Psychiatric Nursing course at a foundation university in Istanbul, Türkiye, who have not previously participated in a similar simulation, are invited to take part. Before the simulation, participants complete a set of questionnaires assessing their knowledge about schizophrenia, empathy level, and caregiving competence. They then take part in a structured simulation session involving a standardized patient portraying a person with schizophrenia. The session includes a preparation phase, a prebriefing session, a 15-minute clinical encounter in which the student conducts a therapeutic interview and mental status examination, and a debriefing session guided by a structured reflective model. Immediately afterward, participants complete the same questionnaires again, along with a scale measuring their perception of the simulation's educational effectiveness. The purpose of the study is to determine whether this type of simulation-based training improves nursing students' knowledge, empathy, and confidence in caring for individuals with schizophrenia, and to contribute evidence on the use of simulation in psychiatric nursing education.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

October 27, 2025

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
Last Updated

August 11, 2026

Status Verified

July 1, 2026

Enrollment Period

7 days

First QC Date

July 30, 2026

Last Update Submit

August 5, 2026

Conditions

Keywords

SchizophreniaSimulation TrainingStudents, NursingEmpathy

Outcome Measures

Primary Outcomes (3)

  • Knowledge About Schizophrenia Questionnaire

    Nursing students' knowledge about schizophrenia will be assessed using the Knowledge About Schizophrenia Questionnaire, originally developed by Ascher-Svanum and adapted into Turkish by Görkem-Atalan, Karaoğlan-Kahiloğulları, and Örsel. The scale consists of 23 unidimensional items, with total scores ranging from 0 to 23. Higher scores indicate a higher level of knowledge about schizophrenia.

    Baseline (before simulation, Day 1) and end of Day 1 (after simulation completion)

  • Toronto Empathy Questionnaire

    Nursing students' empathy levels will be assessed using the Toronto Empathy Questionnaire, originally developed by Spreng et al. and adapted into Turkish by Totan, Doğan, and Sapmaz . The 5-point Likert-type scale consists of 13 items (8 reverse-scored), with total scores ranging from 13 to 65. Higher scores indicate a higher level of empathy

    Baseline (before simulation, Day 1) and end of Day 1 (after simulation completion)

  • Caregiving Competence Scale

    Nursing students' caregiving competence will be assessed using the Caregiving Competence Scale , originally developed by Pearlin et al. and adapted into Turkish by Demir Avcı and Gözüm. The 4-point Likert-type scale consists of 4 items, with total scores ranging from 4 to 16. Higher scores indicate a higher level of perceived caregiving competence

    Baseline (before simulation, Day 1) and end of Day 1 (after simulation completion)

Secondary Outcomes (1)

  • Simulation Effectiveness Tool-Modified

    Baseline (before simulation, Day 1) and end of Day 1 (after simulation completion)

Study Arms (1)

Experimental Group

EXPERIMENTAL

There is one group: The intervention was delivered before students began their psychiatric clinical placement and consisted of four sequential phases - preparation, prebriefing, clinical simulation, and debriefing - with identical learning objectives, environment, scenario, and procedures maintained across all participants to preserve intervention fidelity.

Behavioral: Simulation

Interventions

SimulationBEHAVIORAL

Simulation Intervention: The intervention was delivered before students began their psychiatric clinical placement and consisted of four sequential phases - preparation, prebriefing, clinical simulation, and debriefing - with identical learning objectives, environment, scenario, and procedures maintained across all participants to preserve intervention fidelity.

Experimental Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Enrolled in the Mental Health and Psychiatric Nursing course at the Nursing Department during the 2025-2026 academic year
  • Has not previously participated in a similar schizophrenia scenario-based simulation
  • Voluntarily agrees to participate in the study and provides written informed consent

You may not qualify if:

  • Declines to provide written informed consent
  • Has previously participated in a schizophrenia scenario-based simulation
  • Fails to complete the pre-test or post-test questionnaires in full

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34810, Turkey (Türkiye)

Location

Related Publications (1)

  • 1. Ascher-Svanum, H. (1999). Development and validation of a measure of patients' knowledge about schizophrenia. Psychiatric Services, 50(4), 561-563. https://doi.org/10.1176/ps.50.4.561 2. Görkem-Atalan, S. D., Karaoğlan-Kahiloğulları, A., & Örsel, S. (2018). Şizofreni hakkında bilgi düzeyi ölçeği Türkçe formunun geçerlilik ve güvenilirliği. Bilişsel Davranışçı Psikoterapi ve Araştırmalar Dergisi, 7, 1-6. https://doi.org/10.5455/JCBPR.270028 Spreng, R. N., McKinnon, M. C., Mar, R. A., & Levine, B. (2009). 3. The Toronto Empathy Questionnaire: Scale development and initial validation of a factor-analytic solution to multiple empathy measures. Journal of Personality Assessment, 91(1), 62-71. https://doi.org/10.1080/00223890802484381 4. Totan, T., Doğan, T., & Sapmaz, F. (2012). The Toronto Empathy Questionnaire: Evaluation of psychometric properties among Turkish university students. Eurasian Journal of Educational Research, 46, 179-198. 5.Pearlin, L. I., Mullan, J. T., Semple, S. J., & Skaff, M. M. (1990). Caregiving and the stress process: An overview of concepts and their measures. The Gerontologist, 30(5), 583-594. https://doi.org/10.1093/geront/30.5.583 6. Demir Avcı, Y., & Gözüm, S. (2022). Adaptation and psychometric testing of the Turkish Caregiving Competence Scale. Bezmialem Science, 10(1), 81-87. https://doi.org/10.14235/bas.galenos.2020.4152 7.Leighton, K., Ravert, P., Mudra, V., & Macintosh, C. (2015). Updating the Simulation Effectiveness Tool: Item modifications and reevaluation of psychometric properties. Nursing Education Perspectives, 36(5), 317-323. https://doi.org/10.5480/15-1671 8. Şahin, G., Buzlu, S., Kuğuoğlu, S., & Yılmaz, S. (2020). Reliability and validity of the Turkish version of the Simulation Effectiveness Tool-Modified. Florence Nightingale Journal of Nursing, 28(3), 250-257. https://doi.org/10.5152/FNJN.2020.19157

    BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Merve Geylani, phD

    Istanbul Medipol Unversity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: All participants received the same intervention with no control Group; outcomes were assessed pre- and post- intervention within the same Group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 30, 2026

First Posted

August 11, 2026

Study Start

October 27, 2025

Primary Completion

November 3, 2025

Study Completion

November 3, 2025

Last Updated

August 11, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations