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SCHIZOPHRENIA 1 (Disorder)NCT07757750

Simulation-Based Schizophrenia Training in Nursing Education

A study testing Simulation in people with SCHIZOPHRENIA 1 (Disorder) and Simulation Based Learning, run by Medipol University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Simulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
1 siteTurkey (Türkiye)
Study dates
27 Oct 2025to 3 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul Medipol University

    Istanbul, Beykoz, 34810

Other trials in Turkey (Türkiye)

About this study

Official title: The Effects of Schizophrenia Scenario-Based Simulation on Nursing Students' Knowledge, Empathy, and Caregiving Competence: A Quasi-Experimental Study

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.

Read the detailed description

Design: This study was conducted using a single-group pre-test/post-test quasi-experimental design to evaluate the integrated effect of a schizophrenia scenario-based simulation on nursing students' knowledge, empathy, and caregiving competence levels.

Hypotheses:

H1: Post-test mean knowledge scores of nursing students who participate in the schizophrenia scenario-based simulation will be higher than their pre-test mean scores.

H2: Post-test mean empathy scores of nursing students who participate in the simulation will be higher than their pre-test mean scores.

H3: Post-test mean caregiving competence scores of nursing students who participate in the simulation will be higher than their pre-test mean scores.

Population and Sample: The study population consists of students enrolled in the Mental Health and Psychiatric Nursing course at the Nursing Department of a foundation university in Istanbul, Türkiye, during the 2025-2026 academic year (N= 120). The sample consists of students who had not previously participated in a similar schizophrenia scenario-based simulation and who agreed to participate in the study.

Data Collection Tools: A Personal Information Form (developed by the researchers, covering age, gender, GPA, prior coursework/clinical experience in psychiatric nursing, prior contact with individuals diagnosed with schizophrenia, family history of psychiatric illness, and prior simulation participation), the Knowledge About Schizophrenia Questionnaire, the Toronto Empathy Questionnaire, the Caregiving Competence Scale, and the Simulation Effectiveness Tool-Modified (SET-M) were used.

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.

Preparation Phase: Students attended theoretical coursework on therapeutic communication, the psychiatric nursing process, ethical/legal issues, psychoeducation, mental status examination, and nursing care for schizophrenia. The simulation scenario was developed by the research team, reviewed by three experts in psychiatric nursing and clinical simulation, revised accordingly, and pilot-tested with senior nursing students. Standardized patients (SPs) were trained by a researcher with over 10 years of experience in psychiatric nursing and simulation, following ASPE Standards of Best Practice, including an 8-hour training day and rehearsal sessions to ensure consistent role portrayal.

Prebriefing Phase: Conducted immediately before the simulation (~30 minutes) by the principal researcher, introducing the learning objectives, scenario, roles, process, and data collection forms, and establishing a psychologically safe learning environment. Pre-test questionnaires were completed at the end of this phase.

Clinical Simulation Phase: Conducted individually in a simulation center designed to resemble an inpatient psychiatric ward. Each student engaged in an approximately 15-minute encounter with a standardized patient portraying schizophrenia, during which the student conducted a therapeutic interview and comprehensive mental status examination. Facilitators observed sessions through one-way mirrors using a structured checklist to ensure consistency.

Debriefing Phase: A 60-minute session guided by the PEARLS (Promoting Excellence and Reflective Learning in Simulation) blended debriefing model, structured into reaction, analysis, and summary phases. Post-test questionnaires, including the SET-M, were completed immediately afterward.

Data Analysis Plan: Data are analyzed using SPSS 22.0. Normality is assessed via skewness-kurtosis values. Descriptive statistics are used alongside the paired-samples t-test to compare pre-test and post-test measurements, with statistical significance evaluated at the 95% confidence level (p<0.05)

Being tested
Simulation
Keywords
Schizophrenia, Simulation Training, Students, Nursing, Empathy
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SimulationBehavioural

    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.

Study groups in NCT07757750
Study groupRoleWhat they receive
Experimental GroupExperimentalThere 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.
Receives: Behavioral: Simulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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

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

  3. 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

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

Secondary outcomes (1)
  1. Simulation Effectiveness Tool-Modified

    Nursing students' perceptions of the effectiveness of learning in the simulation environment will be assessed using the Simulation Effectiveness Tool-Modified (SET-M), originally developed by Leighton et al. and adapted into Turkish by Şahin, Buzlu, Kuğuoğlu, and Yılmaz. The 5-point Likert-type scale consists of 18 items across four subscales: Prebriefing, Learning, Confidence, and Debriefing. Total scores range from 18 to 95. Higher scores indicate a more positive perception of the effectiveness of learning within the simulation environment.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2026
  2. Study start27 Oct 2025
  3. Primary completion3 Nov 2025
  4. Study completion3 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
All participants received the same intervention with no control Group; outcomes were assessed pre- and post- intervention within the same Group.
Masking
None (open label)
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07757750
Sponsor's protocol ID
E-10840098-202.3.02-7211
Status last verified
Jul 2026
First submitted
30 Jul 2026
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Simulation in people with SCHIZOPHRENIA 1 (Disorder) and Simulation Based Learning, run by Medipol University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knowledge About Schizophrenia Questionnaire (time frame: Baseline (before simulation, Day 1) and end of Day 1 (after simulation completion)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07757750, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

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