An interventional study of video-based simulation in Simulation Training, Nursing Education and Patient Safety, sponsored by Bartın Unıversity. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Bartın Unıversity · Not applicable, Interventional, and Other
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:
Exclusion Criteria:
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.
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:
Exclusion Criteria:
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.
Bartın Unıversity is the lead sponsor of 47 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Criteria for Discontinuation from the Study:
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 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.
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.
Time frame: 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.
Time frame: 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.
No study locations are listed for this record.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Bartın Unıversity