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

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.