SELF-ASSESSMENT AND KNOWLEDGE LEVEL OF NURSING STUDENTS' PATIENT SAFETY COMPETENCY (Simulation)

THE EFFECT OF VIDEO-BASED SIMULATION ON NURSING STUDENTS' PATIENT SAFETY COMPETENCY SELF-ASSESSMENT AND KNOWLEDGE LEVELS

Patient safety aims to reduce risks during healthcare delivery, prevent avoidable harm, and minimize the consequences of adverse events. Video-based simulation offers a safe learning environment in which nursing students can apply theoretical knowledge. This study aims to evaluate the effect of video-based simulation on nursing students' self-assessed patient safety competency and patient safety knowledge.

This parallel-group randomized controlled trial will recruit 86 third-year nursing students from the Faculty of Health Sciences at Bartın University during the fall semester of the 2026-2027 academic year, with 43 students in each group.

Inclusion Criteria:

• Being a third-year nursing student actively enrolled in the fifth semester.
• Having a cumulative grade point average of 2.00-4.00 on a 4.00 scale.
• Having no difficulty understanding or speaking Turkish.
• Providing voluntary informed consent.

Exclusion Criteria:

• Having previously received structured patient safety training outside the routine nursing curriculum.
• Having graduated from a health vocational high school or an associate degree program in a health-related field.

An independent statistician will conduct stratified randomization based on baseline Patient Safety Knowledge Test scores and cumulative grade point averages. A separate faculty member will administer the intervention in a suitable classroom within the faculty. Triple blinding will involve the researcher, a separate outcome assessor, and a data analyst who is not responsible for randomization. Group identities will remain concealed from these individuals until the prespecified primary analyses are completed. The researcher's access to the simulation administrator panel will also remain restricted during this period. Participants will be informed that everyone will receive the simulation at different times; however, full participant blinding will not be assumed.

The study includes preparation, pilot testing, and main implementation. The educational content, knowledge test, and simulation materials were reviewed by experts and revised accordingly. The simulation was developed with reference to national and international patient safety goals and simulation design standards. Pilot testing involved 10 students for the simulation and 30 students for the data collection tools.

Both groups will receive standardized theoretical patient safety education. The intervention group will additionally complete the video-based simulation, while the control group will receive access after both groups complete their four-week follow-up assessments. Outcomes will be assessed at four time points: before theoretical education, immediately after theoretical education and before simulation, immediately after simulation, and four weeks after the posttest. Control-group assessments will occur at the same time points.

Data collection instruments will include the Descriptive Characteristics Questionnaire, Patient Safety Knowledge Test, Patient Safety Competency Self-Assessment Tool, and Video-Based Simulation Evaluation Form. The primary outcome will be the overall mean competency score, ranging from 1 to 5. The secondary outcome will be the knowledge test score, ranging from 0 to 100. Higher scores indicate better self-assessed competency and greater knowledge, respectively.

Descriptive statistics and repeated-measures analyses will be used to evaluate group, time, and group-by-time effects. The prespecified comparison of change from the video-preintervention assessment to the immediate posttest between groups will assess the immediate additional effect of the simulation. Follow-up assessments will evaluate maintenance of the effect. Effect estimates will be reported with 95% confidence intervals, and missing data will be addressed according to the prespecified analysis plan.

Study Overview

• Status: Not yet recruiting
• Conditions: Nursing Education; Simulation Training; Patient Safety
• Intervention / Treatment: Other: video-based simulation

Detailed Description

Patient safety aims to reduce risks during healthcare delivery, prevent avoidable harm, and minimize the consequences of adverse events. Video-based simulation offers a safe learning environment in which nursing students can apply theoretical knowledge. This study aims to evaluate the effect of video-based simulation on nursing students' self-assessed patient safety competency and patient safety knowledge.

This triple-blind, parallel-group randomized controlled trial will recruit 86 third-year nursing students from the Faculty of Health Sciences at Bartın University during the fall semester of the 2026-2027 academic year, with 43 students in each group.

Inclusion Criteria:

• Being a third-year nursing student actively enrolled in the fifth semester.
• Having a cumulative grade point average of 2.00-4.00 on a 4.00 scale.
• Having no difficulty understanding or speaking Turkish.
• Providing voluntary informed consent.

Exclusion Criteria:

• Having previously received structured patient safety training outside the routine nursing curriculum.
• Having graduated from a health vocational high school or an associate degree program in a health-related field.

Randomization and Blinding

Students who meet the inclusion criteria will complete the Descriptive Characteristics Questionnaire and the Patient Safety Knowledge Test. The data will be securely transferred, using participant codes, to an independent statistician and entered into SPSS. Students will be randomly assigned to the intervention or control group within strata defined by their baseline Patient Safety Knowledge Test scores and cumulative grade point averages. The score ranges used to establish the strata will be determined before randomization. Randomization will be conducted without the researcher's direct involvement, and the allocation list will not be shared with the researcher.

Group allocation information will be shared with a separate faculty member at Bartın University's Faculty of Health Sciences who will be responsible for delivering the intervention. This faculty member will administer the video-based simulation to the intervention group in a suitable classroom within the faculty and will not participate in outcome assessment or statistical analysis.

The researcher will not attend the intervention sessions or have access to the allocation list or records indicating students' participation in the simulation. The software company will restrict the researcher's access to the simulation's administrator panel until data collection and the prespecified primary analyses have been completed, thereby maintaining the researcher's blinding to group allocation.

Through the Participant Information and Informed Consent Form, all students will be informed about the study procedures, random allocation, and the opportunity for all participants to complete the video-based simulation at different times. Students will not be informed of the intervention and control group labels. The control group will receive the simulation after both groups have completed their four-week follow-up assessments. However, because students will know whether they have participated in the simulation, full participant blinding will not be assumed.

Outcome assessments will be conducted using standardized instructions by a separate outcome assessor who is unaware of group allocation. Participants will be asked not to disclose their simulation participation status to the researcher or outcome assessor. Statistical analyses will be conducted by a statistician other than the one responsible for randomization. Groups will be coded as A and B in the analysis dataset, and the correspondence between these codes and the intervention and control groups will not be disclosed to the researcher, outcome assessor, or data analyst until the prespecified primary analyses have been completed.

In this study, triple blinding will involve masking the researcher, outcome assessor, and data analyst to group allocation. The faculty member delivering the intervention will not be blinded. The study will be reported in accordance with the CONSORT 2025 guidelines, explicitly identifying the blinded parties and describing how blinding will be maintained (Hopewell et al., 2025).

Study Procedures

The study includes preparation, pilot testing, and main implementation. The educational content, knowledge test, and simulation materials were reviewed by experts and revised accordingly. The simulation was developed with reference to national and international patient safety goals and simulation design standards. Pilot testing involved 10 students for the simulation and 30 students for the data collection tools.

Both groups will receive standardized theoretical patient safety education. The intervention group will additionally complete the video-based simulation. Outcomes will be assessed at four time points: before theoretical education, immediately after theoretical education and before simulation, immediately after simulation, and four weeks after the posttest. Control-group assessments will occur at the same time points.

Outcome Measures

Data collection instruments will include the Descriptive Characteristics Questionnaire, Patient Safety Knowledge Test, Patient Safety Competency Self-Assessment Tool, and Video-Based Simulation Evaluation Form. The evaluation form will be administered only to students who complete the simulation.

The primary outcome will be the overall mean score on the Patient Safety Competency Self-Assessment Tool, ranging from 1 to 5. The secondary outcome will be the Patient Safety Knowledge Test score, ranging from 0 to 100. Higher scores indicate higher self-assessed patient safety competency and greater patient safety knowledge, respectively.

Statistical Analysis

Descriptive statistics and repeated-measures analyses will be used to evaluate group, time, and group-by-time effects. The prespecified between-group comparison of change from the intermediate assessment, conducted immediately before simulation, to the immediate posttest will assess the immediate additional effect of video-based simulation. Follow-up comparisons will evaluate whether the effect is maintained four weeks later. Effect estimates will be reported with 95% confidence intervals, and missing data will be addressed according to the prespecified analysis plan.

• Study Type: Interventional
• Enrollment (Estimated): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MERVE KIRŞAN BÜYÜKTARAKÇI; Phone Number: 5051220233; Email: mervekirsan1167@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Being a third-year nursing student actively enrolled in the fifth semester.
• Having a cumulative grade point average between 2.00 and 4.00 on a 4.00 scale.
• Having no difficulty understanding or speaking Turkish.
• Being willing to participate in the study.

Exclusion Criteria:

• Having previously received patient safety training.
• Having graduated from a health vocational high school or an associate degree program in a health-related field.

Criteria for Discontinuation from the Study:

• Requesting to withdraw from the study.
• Not attending the theoretical patient safety education provided by the researcher.
• Not completing the data collection forms or completing them incompletely.
• Not completing the video-based simulation application, for participants in the intervention group.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Video based simulation; Participants will receive standardized theoretical patient safety education followed by video-based simulation through a mobile application in a suitable faculty classroom. Researcher-developed scenarios and questions, based on national and international patient safety goals, were reviewed by academic experts and revised accordingly. Participants will log in using unique codes and answer 16 questions once each, presented between video segments. Each confirmed response will be automatically saved and scored, with immediate explanatory feedback. Responses, scores, progress, and completion status will be recorded. A faculty member uninvolved in outcome assessment or statistical analysis will administer the simulation.	Other: video-based simulation; Participants will log in using unique participant codes. The video-based simulation will be structured around the learning objectives and include 16 questions presented between video segments. Participants will answer each question once, without a time limit. Each confirmed response will be automatically saved and scored, and immediate explanatory feedback will be provided. Correct answers will earn points; incorrect answers will receive no points. The system will record responses, scores, progress, and completion status. An optional break will be offered after the first section. If a technical interruption occurs, participants will resume from their last saved point without changing previously confirmed responses. Upon completion, participants will be able to view their total score.
Active Comparator: Control group; Participants in the control group will receive standardized theoretical patient safety education but will not undergo video-based simulation during the same period as the intervention group. Both groups will be assessed at the same time points. After both groups complete the four-week follow-up assessments, the control group will also receive the simulation for educational purposes, with no further outcome assessments.	Other: video-based simulation; Participants will log in using unique participant codes. The video-based simulation will be structured around the learning objectives and include 16 questions presented between video segments. Participants will answer each question once, without a time limit. Each confirmed response will be automatically saved and scored, and immediate explanatory feedback will be provided. Correct answers will earn points; incorrect answers will receive no points. The system will record responses, scores, progress, and completion status. An optional break will be offered after the first section. If a technical interruption occurs, participants will resume from their last saved point without changing previously confirmed responses. Upon completion, participants will be able to view their total score.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Mean Score on the Patient Safety Competency Self-Assessment Tool	Self-assessed patient safety competency will be measured using the Turkish version of the Patient Safety Competency Self-Assessment Tool. The tool consists of 41 items covering knowledge (6 items), skills (21 items), and attitudes (14 items). Each item is rated on a five-point Likert scale. Items 38 and 39 are reverse-scored. The overall score is calculated as the mean of all item scores and ranges from 1 to 5 points. Higher scores indicate higher self-assessed patient safety competency.	Before theoretical education; immediately after theoretical education and before simulation; immediately after simulation; and four weeks after the posttest. Both groups will be assessed at the same time points.
Patient Safety Knowledge Test Score	Students' patient safety knowledge will be assessed using the researcher-developed Patient Safety Knowledge Test. The test consists of 25 multiple-choice questions covering patient safety culture and fundamental concepts, patient safety goals and safe care practices, the classification and analysis of medical errors, and incident reporting systems. Each question has five response options and one correct answer. Correct answers will receive 4 points, while incorrect or unanswered questions will receive 0 points. Total scores range from 0 to 100, with higher scores indicating greater patient safety knowledge.	Before theoretical education; immediately after theoretical education and before simulation; immediately after simulation; and four weeks after the posttest. Both groups will be assessed at the same time points.

Collaborators and Investigators

• Sponsor: Bartın Unıversity

Publications and helpful links

General Publications

• Abdelaliem, S. M. F., & Alsenany, S. A. (2022, September). Factors affecting patient safety culture from nurses' perspectives for sustainable nursing practice. In Healthcare (Vol. 10, No. 10, p. 1889). MDPI. Adeyemi, C., Adegoke, B. O., & Odugbose, T. (2024). The impact of healthcare information technology on reducing medication errors: A review of recent advances. international Journal of Frontiers in Medicine and Surgery Research [online], 5(2), 20-29. Agbar, F., Zhang, S., Wu, Y., & Mustafa, M. (2023). Effect of patient safety education interventions on patient safety culture of health care professionals: Systematic review and meta-analysis. Nurse education in practice, 67, 103565. Aghighi, N., Aryankhesal, A., & Raeissi, P. (2022). Factors affecting the recurrence of medical errors in hospitals and the preventive strategies: a scoping review. Journal of Medical Ethics and History of Medicine, 15.

Helpful Links

• <p>World Health Organization (2024). Global patient safety report.</p>
• <p>Joint Commission International 2023, International Patient Safety Goals.</p>

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: July 15, 2026
• First Submitted That Met QC Criteria: October 31, 2026
• First Posted (Actual): November 4, 2026

Study Record Updates

• Last Update Posted (Actual): November 4, 2026
• Last Update Submitted That Met QC Criteria: October 31, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2025 - 1001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No