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Simulation TrainingSimulationNCT07471737

Patient Safety and Medical Errors in Nursing Education: Learning by Doing and Experiencing With Simulated Patients

A study testing simulated patient in people with Simulation Training and Patient Safety, run by Gazi 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 research will be conducted with the aim of enabling first year nursing students to learn about patient safety and medical errors through simulated patient education. Students will participate in the theoretical and practical laboratory work of the Fundamentals of Nursing course during the spring semester of… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
simulated patient
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Mar 2026to 29 May 2026
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

  • students who had enrolled in the Fundamentals of Nursing course for the first time
  • had no more than 20% attendance
  • volunteered to participate in the study

Who cannot join

  • students who have previously performed a nursing practice on a simulated patient
  • the student's unwillingness to continue the practices
  • failure to complete the data collection forms.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Gazi University Faculty of Nursing

    Ankara

Other trials in Turkey (Türkiye)

About this study

This research will be conducted with the aim of enabling first year nursing students to learn about patient safety and medical errors through simulated patient education. Students will participate in the theoretical and practical laboratory work of the Fundamentals of Nursing course during the spring semester of 2025-2026. The research will be implemented after the laboratory applications.

This research will evaluate the impact of simulated patient education on the outcomes of first-year students' patient safety goals ('Correct identification of patients', 'Ensuring medication safety', 'Reducing the risk of healthcare-associated infections' and 'Reducing the risk of patient harm from falls'). The researchers have developed six scenarios related to patient safety and medical errors. The research will be conducted in a randomised controlled experimental design (n=62). First-year nursing students will be administered the Patient Safety Competency Self-Evaluation Scale (pre-test), the Medical Error Tendency Scale (pre-test), and a knowledge test (pre-test). Students will be randomised into experimental and control groups based on their knowledge test (pre-test) mean scores.

Read more

After all students in the experimental and control groups have completed the educator-centred theoretical and laboratory applications, the study will proceed to the application phase. First, those in the experimental group will participate in scenario applications (first and second scenarios) to gain experience with simulated patients. The first scenario covers applications related to the objectives of 'correct identification of patients' and 'ensuring medication safety'. The second scenario covers applications related to the objectives of 'reducing the risks associated with falls' and 'reducing the risk of healthcare-associated infections'. One week after the simulation, the experimental group will undergo psychomotor skill assessment related to patient safety on a simulated patient, and the control group will undergo psychomotor skill assessment on a low-fidelity manikin using control ists (first skill assessment). Subsequently, all students will undergo the Patient Safety Competency Self-Evaluation Scale (post-test), the Medical Error Tendency Scale (post-test), and a knowledge test (post test). Eight weeks later, psychomotor skill assessments (second skill assessment) using control lists, the Patient Safety Competency Self-Evaluation Scale (follow up-test), the Medical Error Tendency Scale (follow-up test), and the knowledge test (follow-up test) will be administered again using the same method.

The third and fourth scenarios will be used in the first psychomotor skill assessment exam that the experimental and control groups will take. The third scenario includes skills related to the objectives of 'verifying patient identity' and 'ensuring medication safety'. The fourth scenario includes skills related to the objectives of 'reducing the risk of healthcare-associated infections' and 'reducing the risks associated with falls'. The fifth and sixth scenarios will be used in the second psychomotor skills assessment exam for the experimental and control groups. The fifth scenario includes skills related to the objectives of 'verifying patient identity' and 'ensuring medication safety'. The sixth scenario includes skills related to the objectives of 'reducing the risk of healthcare-associated infections' and 'reducing the risks associated with falls'.

Read the detailed description

One of the contemporary teaching methods that meets the requirements of today's nursing education system is simulation (Ünver et al., 2018; Özdemir, 2023). The type of simulation that has gained worldwide recognition is simulated patient application (Johnson et al., 2020). It is often emphasised that nursing students have no chance to make mistakes in clinical practice (Kuo et al., 2020). The dilemma created by this situation necessitates the use of teaching methods that do not carry risk, such as simulated patients, and provide learning experiences through doing and experiencing. Working with simulated patients allows students to experience real patient care in a safe environment (Yalcinturk, Ustun, 2023). Students can work individually or in groups in simulated patient education and see the normal or abnormal results of the intervention they apply (Ünver et al., 2018). In this context, simulated patient education supports students to be active throughout the process rather than passive listeners, to use their cognitive, affective, and psychomotor skills, and to relate the data they obtain from the simulated patient. In simulated patient education, a major advantage that increases the effectiveness of the training is that students experience situations that put patient safety at risk first-hand and, if they cannot prevent the risks, see the possible harm in advance (Sarmasoğlu et al., 2016; Uslu and Yavuz van Giersbergen, 2019). In this context, traditional teaching methods are insufficient in imparting knowledge, skills, and attitudes related to patient safety, whereas simulated patient education provides learning by doing and experiencing.

This research will be conducted in a randomised controlled experimental design with the aim of nursing students learning patient safety and medical errors through simulated patient education by doing and experiencing.

The population of the study will consist of students enrolled in the Fundamentals of Nursing course at Gazi University Faculty of Nursing in the 2025-2026 academic year. For the sample size, a power analysis was performed using the G*Power Version 3.1.9.7 programme on 269 students enrolled in the Fundamentals of Nursing course during the 2024-2025 academic year (type 1 error: 0.05, type 2 error: 0.20, and effect size = 0.80). The sample size was determined to be 52 people in total, with 26 people in each group. In order not to reduce the statistical power of the study, it was determined that 20% more students should be included in the sample, and the sample group should consist of 62 students. In this context, the distinction will be made with 31 students in the experimental group and 31 students in the control group.

The inclusion criteria for the study were: students who had enrolled in the Fundamentals of Nursing course for the first time, had no more than 20% attendance, and volunteered to participate in the study. The exclusion criteria for the study are students who have previously performed a nursing practice on a simulated patient. The dropout criteria are the student's unwillingness to continue the practices and failure to complete the data collection forms.

Students will be administered the Patient Safety Competency Self-Evaluation Scale (pre-test), the Medical Error Tendency Scale (pre-test), a knowledge test (pre-test) developed by the researchers, and a Descriptive Characteristics form. Students will be randomised into the experimental and control groups based on their knowlege test (pre-test) mean scores.

After all students in the experimental and control groups have completed the educator-centred theoretical and laboratory applications, the study will proceed to the application phase. First, those in the experimental group will participate in scenario applications (first and second scenarios) to gain experience with simulated patients. The first scenario covers applications related to the objectives of 'correct identification of patients' and 'ensuring medication safety'. The second scenario covers applications related to the objectives of 'reducing the risks associated with falls' and 'reducing the risk of healthcare-associated infections'. One week after the simulation, the experimental group will undergo psychomotor skill assessment related to patient safety on a simulated patient, and the control group will undergo psychomotor skill assessment on a low-fidelity manikin using control lists (first skill assessment). Subsequently, all students will undergo the Patient Safety Competency Self-Evaluation Scale (post-test), the Medical Error Tendency Scale (post-test), and a knowledge test (post test). Eight weeks later, psychomotor skill assessments (second skill assessment) using control lists, the Patient Safety Competency Self-Evaluation Scale (follow up-test), the Medical Error Tendency Scale (follow-up test), and the knowledge test (follow-up test) will be administered again using the same method.

The third and fourth scenarios will be used in the first psychomotor skill assessment exam that the experimental and control groups will take. The third scenario includes skills related to the objectives of 'verifying patient identity' and 'ensuring medication safety'. The fourth scenario includes skills related to the objectives of 'reducing the risk of healthcare-associated infections' and 'reducing the risks associated with falls'. The fifth and sixth scenarios will be used in the second psychomotor skills assessment exam for the experimental and control groups. The fifth scenario includes skills related to the objectives of 'verifying patient identity' and 'ensuring medication safety'. The sixth scenario includes skills related to the objectives of 'reducing the risk of healthcare-associated infections' and 'reducing the risks associated with falls'.

Being tested
simulated patient
Keywords
nursing education, simulated patient, patient safety, medical errors

What participants receive

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

  • simulated patientOther

    The experimental group will perform the procedure on simulated patients. They will carry out two scenario-based applications related to patient safety and medical errors.

Study groups in NCT07471737
Study groupRoleWhat they receive
simulated patientExperimentalThe simulated patient training will conduct to will be used in the experimental group. They will carry out two scenario applications related to patient safety and medical errors.
Receives: Other: simulated patient
traditional education (control group)No interventionIn the control group, educator-centered traditional laboratory practice will be carried out.

What is being measured

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

  1. Patient Safety Competency Self-Evaluation Scale

    Scale was developed by Güneş et al. (2017) to determine students' self-assessments of their patient safety competence. The scale is a 5-point Likert scale and consists of three categories: knowledge (7 items), skills (1 item), and attitudes (10 items). A higher score on the scale indicates increased competence in patient safety. The Cronbach's alpha coefficient is 0.95.

    Measured: an average of eight weeks from baseline to study completion

  2. Medical Error Tendency Scale

    It was developed by Özata and Altunkan (2010). The scale is a 5-point Likert scale and consists of 49 items. The scale consists of five subscales: medication and transfusion practices (18 items), falls (5 items), hospital infections (12 items), communication (5 items), and patient monitoring and material safety (9 items). Each item can be rated as 'never', 'very rarely', 'most of the time', "usually", or 'always'. The maximum score that can be obtained from the scale is 245 and the minimum score is 49. It is stated that as the average score increases, the tendency to make medical errors is low. The Cronbach's alpha value of the scale is 0.93.

    Measured: an average of eight weeks from baseline to study completion

  3. Knowledge test

    A draft has been prepared by researchers in line with the literature (Baykara et al., 2021; Potter et al., 2021; Yazıcı and Yılmaz, 2019). It is appropriate for the content of patient safety and is suitable for assessing students' knowledge. It consists of 22 closed-ended questions, each with five options and a single correct answer. It will be submitted for expert review and undergo a pilot study. The total score achievable on the knowledge test ranges from 0 to 100.

    Measured: an average of eight weeks from baseline to study completion

  4. Control list

    It has been prepared by researchers and in line with the literature (Baykara et al., 2021; Berman et al., 2022). It consists of application steps that detail the psychomotor skill steps related to protecting patient safety. It has been created in the form of a graded scoring key to enable objective observation of students. It is categorised as 'Applied (2 points)', 'Incorrect/Incomplete (1 point)', and 'Not applied' (0 points). The total score that can be obtained from the checklist ranges from 0 to 100.

    Measured: one week and eight weeks after the intervention

Timeline

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

  1. First posted13 Mar 2026
  2. Study start20 Mar 2026
  3. Primary completion29 May 2026
  4. Study completion29 May 2026

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07471737
Sponsor's protocol ID
E.1361353
Other IDs
225S429
Acronym
Simulation
Status last verified
Mar 2026
First submitted
10 Mar 2026
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing simulated patient in people with Simulation Training and Patient Safety, run by Gazi 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 10 Jul 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?

Patient Safety Competency Self-Evaluation Scale (time frame: an average of eight weeks from baseline to study completion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 10 Jul 2026.

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