Nursing EducationNCT07637136
Effects of Simulation Fidelity on Patient-Centered Care Competency, Empathy, and Learning Outcomes in Nursing Students: A Randomized Controlled Trial
A study testing Simulation-Based Nursing Education in people with Nursing Education and Simulation Based Learning, run by Atılım University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial examines the effects of simulation fidelity on nursing students' patient-centered care competency, empathy, learning self-confidence, and satisfaction. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nursing Education, Simulation Based Learning, Patient-centered Care
- What is being tested?
- Simulation-Based Nursing Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 May 2026to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Did not complete the informed consent form
- Withdrawal of consent at any point during the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atilim University, Faculty of Health Sciences, Nursing Skills Laboratory
Ankara, 06830
About this study
Official 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
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.
Read the 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.
- Conditions
- Nursing Education, Simulation Based Learning, Patient-centered Care, Empathy, Nursing Students
- Being tested
- Simulation-Based Nursing Education
- Keywords
- simulation fidelity, standardized patient, manikin simulation, nursing students, patient-centered care, empathy, learning self-confidence, debriefing, randomized controlled trial, nursing education Turkey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation-Based Nursing EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Simulation-Based Nursing Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Immediately after the simulation session
Secondary outcomes (2)
Student Satisfaction and Self-Confidence in Learning Scale Score
Total score obtained from the Student Satisfaction and Self-Confidence in Learning Scale measuring students' satisfaction and self-confidence following simulation
Measured: Immediately after the simulation session
Perceived Reality of Simulation
Semi-structured interview responses assessing students' perceived realism of the simulation experience
Measured: Immediately after the simulation session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start12 May 2026
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Nursing EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atılım University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ECEM OZGUL, PhD, Principal investigator, Atilim University School of Health Sciences, Department of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637136
- Sponsor's protocol ID
- E-59394181-100-136938
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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).
Publications
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.
PubMed 27215280Britz 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.
PubMed 39134984Karaçay, 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.
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.
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.
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.
PubMed 38733958Cant 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.
PubMed 27902949Shin 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.
PubMed 25459172
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07637136
- Acronym / sponsor ID
- E-59394181-100-136938
- Conditions
- Nursing Education, Simulation Based Learning, Patient-centered Care, Empathy, Nursing Students
- Keywords
- simulation fidelity, standardized patient, manikin simulation, nursing students, patient-centered care, empathy, learning self-confidence, debriefing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Atılım UniversityUniversity, hospital or other
- Study start
- 12 May 2026 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized Patient Group | Experimental | Behavioral: Simulation-Based Nursing EducationParticipants in this group will perform a myocardial infarction nursing care scenario with a trained actor portraying the patient in a standardized patient simulation. |
| Manikin Group | Active comparator | Behavioral: Simulation-Based Nursing EducationParticipants in this group will perform the same myocardial infarction nursing care scenario using a high-fidelity manikin simulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Did not complete the informed consent form
- Withdrawal of consent at any point during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulation-Based Nursing EducationA 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. | Behavioural | Manikin Group, Standardized Patient Group |
Primary outcome
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
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
2 secondary outcomes
Student Satisfaction and Self-Confidence in Learning Scale Score
Time frame: Immediately after the simulation session
Perceived Reality of Simulation
Time frame: Immediately after the simulation session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Results publication: PubMed 27215280Kim 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.
- Results publication: PubMed 39134984Britz 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.
- Results publicationKaraçay, 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.
- Results publicationYanik, 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.
- Results publicationSaygılı, 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.
- Results publication: PubMed 38733958Akpinar 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.
- Results publication: PubMed 27902949Cant 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.
- Results publication: PubMed 25459172Shin 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.
- Atilim University official website, institution where the study is conductedLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ECEM OZGUL, PhD principal investigator
Atilim University School of Health Sciences, Department of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation-Based Nursing Education in people with Nursing Education and Simulation Based Learning, run by Atılım 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 2 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: under way, not looking for participants, as of the sponsor's last update on 9 Jun 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?
This study is still under way. Results are not available in the source record yet.
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?
Patient-Centered Care Competency Scale Score (time frame: Immediately after the simulation session). The study lists 2 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 NCT07637136, which also lists 8 linked publications.
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 9 Jun 2026.