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IRCT20260722070297N1 IRCT 2026-07-23 Iran University of Medical Sciences Exploring problem-based learning pbl Investigating the Impact of Problem-Based Learning on Enhancing the Clinical Performance of Operating Room Students in Cataract Surgery 2026-09-23 anticipated 36 Recruiting https://irct.ir/trial/91825 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: 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. N/A Cataract. Intervention 1: Intervention group: Students in this group will receive Problem-Based Learning (PBL) training. Training sessions will be conducted in groups of 6 to 8 students with an instructor acting as a facilitator. In each session, a clinical scenario related to cataract surgery will be presented to the students. Students will analyze the problem, define learning objectives, independently study reliable sources, and engage in group discussions to identify appropriate solutions. The facilitator guides and directs the process without providing direct answers. The training consists of 2 sessions (each 2 hours) held one day before the start of the ophthalmology clinical internship. Clinical scenarios include topics such as operating room preparation, equipment sterilization, scrub table management, instrument delivery to the surgeon, infection control, and management of intra-operative complications. After completing the training sessions, students will enter the clinical internship, and their clinical performance will be assessed during the last three days of the internship using a standardized checklist. Intervention 2: Control group: Students in this group will receive traditional lecture-based training delivered by the relevant instructor. Training sessions will be held in-person using slides and verbal explanations by the instructor. Educational content includes theoretical topics of cataract surgery, surgical steps, required equipment and instruments, sterilization principles, and the role of the scrub nurse. The training consists of 2 sessions (each 2 hours) held one day before the start of the ophthalmology clinical internship. After completing the training sessions, students will enter the clinical internship, and their clinical performance will be assessed during the last three days of the internship using a standardized checklist. Yes - There is a plan to make this available What will be shared: 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. When: 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. To whom: 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. Conditions: 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. Where to obtain: 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). How to obtain: 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. Comments:
public reza feizi
Iran University of Medical Sciences
tehran Iran (Islamic Republic of) 1449654535 +98 918 335 5482 fayzireza710227@gmail.com Iran University of Medical Sciences scientific reza feizi
Iran University of Medical Sciences
tehran Iran (Islamic Republic of) 1449614535 +98 918 335 5482 fayzireza710227@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) 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.2. Active enrollment and attendance in the "Clinical Internship in Ophthalmology" course in the current academic semester.3. No history of failing the aforementioned theoretical course (if previously failed, the student may be re-entered in the next semester after passing it again).4. Providing written informed consent to participate in the study. 18 years no limit Both 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).2. Withdrawal from the university or dropping the ophthalmology internship course during the semester.3. Absence of more than 10% of the internship sessions (equivalent to 2 out of 20 internship days) without a valid excuse.4. Incomplete completion of the assessment checklists by the researcher for any reason (e.g., student illness, unauthorized absence, or technical problems in data recording).5. Deliberate disclosure of PBL training content by a student in the intervention group to a student in the control group (if identified, the student will be excluded from the final analysis and their data will be discarded). Other Other Intervention group: Students in this group will receive Problem-Based Learning (PBL) training. Training sessions will be conducted in groups of 6 to 8 students with an instructor acting as a facilitator. In each session, a clinical scenario related to cataract surgery will be presented to the students. Students will analyze the problem, define learning objectives, independently study reliable sources, and engage in group discussions to identify appropriate solutions. The facilitator guides and directs the process without providing direct answers. The training consists of 2 sessions (each 2 hours) held one day before the start of the ophthalmology clinical internship. Clinical scenarios include topics such as operating room preparation, equipment sterilization, scrub table management, instrument delivery to the surgeon, infection control, and management of intra-operative complications. After completing the training sessions, students will enter the clinical internship, and their clinical performance will be assessed during the last three days of the internship using a standardized checklist Control group: Students in this group will receive traditional lecture-based training delivered by the relevant instructor. Training sessions will be held in-person using slides and verbal explanations by the instructor. Educational content includes theoretical topics of cataract surgery, surgical steps, required equipment and instruments, sterilization principles, and the role of the scrub nurse. The training consists of 2 sessions (each 2 hours) held one day before the start of the ophthalmology clinical internship. After completing the training sessions, students will enter the clinical internship, and their clinical performance will be assessed during the last three days of the internship using a standardized checklist. Clinical performance score of students in the scrub role during cataract surgery, measured using a standardized 30-item checklist (including three domains: pre-operative, intra-operative, and post-operative). Each item is scored on a three-point scale (correct = 2, incomplete = 1, incorrect = 0), with a total score range of 0 to 60. The checklist has been previously validated in Iranian studies. Assessment is performed during the last three days of the internship (post-intervention) by two independent assessors. Timepoint: Pre-test: One day before the start of the ophthalmology clinical internship (baseline performance assessment)Post-test: During the last three days of the clinical internship (post-intervention performance assessment). Method of measurement: A standardized 30-item checklist for assessing scrub performance in cataract surgery, including three domains: pre-operative, intra-operative, and post-operative. Each item is scored on a three-point scale (correct = 2, incomplete = 1, incorrect = 0), with a total score range of 0 to 60. This checklist has been previously validated in Iranian studies. Assessment is performed by the principal investigator and a peer colleague (two independent assessors), and the mean score of the two assessors is considered as the final score for each student. Iran University of Medical Sciences Approved 2026-07-08 Ethics committee of iran University of Medical Sciences Iranian Medical Sciences-Medical Education Department تهران Tehran Iran (Islamic Republic of)