NCT07471737

Brief 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 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. 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). Six 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'.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

March 10, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

March 20, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2026

Completed
Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

March 10, 2026

Last Update Submit

March 17, 2026

Conditions

Keywords

nursing educationsimulated patientpatient safetymedical errors

Outcome Measures

Primary Outcomes (4)

  • 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.

    an average of eight weeks from baseline to study completion

  • 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.

    an average of eight weeks from baseline to study completion

  • 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.

    an average of eight weeks from baseline to study completion

  • 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.

    one week and six weeks after the intervention

Study Arms (2)

simulated patient

EXPERIMENTAL

The 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.

Other: simulated patient

traditional education (control group)

NO INTERVENTION

In the control group, educator-centered traditional laboratory practice will be carried out.

Interventions

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.

simulated patient

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Faculty of Nursing

Ankara, Turkey (Türkiye)

Location

Central Study Contacts

Evrim EYİKARA SARITAŞ

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor, Principal Investigator

Study Record Dates

First Submitted

March 10, 2026

First Posted

March 13, 2026

Study Start

March 20, 2026

Primary Completion

May 29, 2026

Study Completion

May 29, 2026

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations