Investigating the Impact of Problem-Based Learning on Enhancing the Clinical Performance of Operating Room Students in Cataract Surgery

To determine the effect of the Problem-Based Learning educational method on the clinical performance of operating room students in cataract surgery

Interventional educational randomized controlled trial with parallel groups

The study will be conducted in the Faculty of Paramedical Sciences and the operating room of the teaching hospitals of Iran University of Medical Sciences. After the pre-test, the seventh semester operating room students will be divided into two groups: PBL and traditional, receive the intervention, and then the post-test will be conducted with a standard checklist.

All seventh semester undergraduate students in the operating room Inclusion Criteria: 1. Successful completion of the theoretical course "Eye Surgery Technology and Its Care" with a minimum grade of 10 (out of 20) in the undergraduate program of Operating Room. Exclusion Criteria: 1. Voluntary withdrawal of the student from the study at any stage (without the need to provide any reason and without any negative consequences on course grades, internship evaluations, or relationship with faculty members).

Students in this group participate in problem-based learning (PBL) training sessions before beginning their ophthalmology internship. In these sessions, clinical scenarios related to cataract surgery are presented and students work in groups of 6 to 8 to analyze the problem, set learning goals, engage in independent study, and engage in group discussion.

Clinical performance score based on a standardized 30-item checklist for scrub performance in cataract surgery (including three domains: pre-operative, intra-operative, and post-operative); comparison of mean pre-test and post-test scores within each group; comparison of mean post-test scores between the two groups

After selecting the study sample, participants will be randomly allocated to two groups (PBL group and control group) using a random number table generated by IBM SPSS version 16 software, with a block randomization method using variable block sizes of 4 and 6 (allocation ratio 1:1). To ensure allocation concealment, the allocation sequence will be prepared by an independent person and placed in opaque, sealed, sequentially numbered envelopes. The principal investigator will remain blinded to the group assignment of each participant until the moment the envelope is opened.

Participant Data: Participant personal data (name, surname, contact number, and student number) will not be shared in any way and will be kept only with the principal investigator and under a strong password. Study Data: The final file of coded data (including clinical performance scores based on a 30-item checklist and basic demographic information such as age and gender, without any personally identifiable information) as well as the final version of the study protocol will be made available to other researchers upon acceptance of the original article, via direct request to the principal investigator (Reza Feizi). How to Share: After receiving a written request stating the purposes of use, the coded data will be sent to the applicant via secure email.

Access to data will begin 6 months after the publication of the initial study results (after acceptance of the article) and will continue for 5 years.

Full access to de-identified data (including the link between the unique code and the student’s identity): Principal researcher (Reza Feizi) – for data management and final analysis. Access to raw coded data (completed checklists without names): Principal researcher (Reza Feizi) – for analysis and reporting. Supervisor (Dr. Zohreh Sohrabi) – only to monitor the accuracy of the research implementation. Peer (Second Evaluator) – only to complete the performance evaluation checklists (access to paper checklists with a three-digit code). Access to final results (aggregated and anonymous reports): Members of the University Research Ethics Committee – to monitor ethical compliance. Professors and instructors of the operating room group – only to be aware of the group results (no access to individual data). Editors and reviewers of scientific journals – if the article is accepted, anonymous and aggregated data will be provided.

Purpose of Data/Document Use: Coded and anonymized data (including clinical performance scores and basic demographic information) will be made available to other researchers for valid scientific and research purposes only. These purposes include secondary analyses, meta-analyses, systematic reviews, designing similar studies in the field of medical education, and improving educational programs in the operating room. Use of data for commercial, profit-making, or diagnostic purposes of individuals is not permitted in any way. Conditions for Data/Document Use: 1. The applicant must send his/her written request to the principal investigator (Reza Feizi) stating the exact title of the study, objectives, analysis method, and intended use. 2. Use of data is permitted only for the same purpose stated in the request, and any change in the purpose requires obtaining new permission from the principal investigator. 3. All analyses and uses must be accompanied by a full mention of the source and reference to the original study (dissertation or published article). 4. Under no circumstances does the applicant have the right to reconstruct the identity of the participants or attempt to reconnect the coded data to identifying information. 5. The data received must not be transferred to any other third party, natural or legal, except with the express written permission of the principal investigator. 6. After the analysis is completed, the applicant is required to report a summary of the results obtained for the information of the principal investigator.

Name: Reza Feizi Position: Ph.D. Candidate in Medical Education, Iran University of Medical Sciences Email: fayzireza710227@gmail.com Phone: +98 918 335 5482 Supervisor Contact Information (for final approval of requests): Name: Dr. Zohreh Sohrabi Position: Professor, Department of Medical Education, Iran University of Medical Sciences Email: (to be coordinated through the principal investigator) Overseeing Authority for the Sharing Process (for follow-ups): Organization: Iranian Registry of Clinical Trials (IRCT) Email: admin@irct.ir Phone: +98 21 8670 5503 Address: IRCT administration team, Central Library Building, Iran University Campus, Hemmat freeway, next to Milad tower, Tehran, Iran. Postal Code: 14496-14535 Request Submission Process (in order of priority): First priority: Submit a written request via email to the principal investigator (fayzireza710227@gmail.com), specifying the exact research title, objectives, analysis methods, and intended use of the data. Second priority: If no response is received within two weeks, follow up by phone with the principal investigator (+98 918 335 5482) during office hours. Third priority: If further follow-up or complaint is necessary, submit a request to the Iranian Registry of Clinical Trials (IRCT) via email (admin@irct.ir) or phone (+98 21 8670 5503).

Written request by the applicant: The applicant must send their written request via email to the principal investigator (Reza Feizi). This request must include the exact title of the study, objectives, intended analysis method, type of data use, and commitment to confidentiality. Initial review by the principal investigator (maximum 7 working days): The principal investigator reviews the request for completeness of information, suitability with the study objectives, and compliance with ethical standards. If additional information is needed, the applicant will be asked to complete the missing items. Referral to the supervisor for final approval (maximum 5 working days): The completed request is referred to the supervisor (Dr. Zohreh Sohrabi) for final scientific and ethical approval. Data preparation (maximum 10 working days): After final approval, the principal investigator extracts the coded and anonymized data from the original file, checks its accuracy, and prepares the final file for submission. Sending data to the applicant: The requested data will be sent to the applicant via secure email (using file encryption). Total expected time from the time of sending the request to receiving the data: Maximum 4 weeks (28 working days). Conditions for cancellation or stopping the process: If the applicant does not complete the requested information within 2 weeks, the application will be canceled and the applicant must start the process again from the beginning. If the request conflicts with ethical standards or the objectives of the study, the principal investigator will reject the request, stating the reason in writing.