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IRCT20220518054911N1 IRCT 2026-02-05 Ardabil University of Medical Sciences Effect of a Flipped Classroom Based on Simulation Software on the Learning of Operating Room Students A comparative evaluation of the impact of a simulator-based flipped classroom and a file-based flipped classroom on the learning level of operating room students 2026-02-24 anticipated 70 Complete https://irct.ir/trial/88845 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, a census sampling method will be used, and all operating room students of Ardabil University of Medical Sciences who meet the inclusion criteria during the academic year 2025–2026 will be included in the study. To create homogeneous groups and to prevent the effects of students’ grade point average and academic semester on the study results, stratified randomization will be used. Students’ grade point average will be divided into three categories (less than 15, between 15 and 17, and higher than 17). In addition, students’ academic semester will be divided into three categories, including semesters 4, 6, and 8. Then, students from each category will be equally and randomly assigned to the intervention and control groups. Randomization within each category will be performed using student identification numbers through an Online Random Number Generator (Google, California). In this website, the “Lists and Strings and Maps, Oh My!” section will be used for randomization, in such a way that the first half of the numbers displayed in the list will be allocated to the control group and the second half to the intervention group, Blinding description: The data analyst will have no information about which data and groups were in the control or intervention group. N/A Learning of operating room students. Intervention 1: Intervention group: This group must receive prior preparations (the first session on gallbladder anatomy and laparoscopic instruments) before the main educational intervention (the second session on laparoscopic cholecystectomy training). Before attending the in-person class, students are asked to install the Touch Surgery simulator on their phones and observe laparoscopic cholecystectomy in learning mode. Since the software instructions are in English, the researcher provides a translated and voice-over PowerPoint of the surgical steps. Students then attend the in-person class the following day.At the beginning of the class, a short quiz will be held to motivate students, and its score will count toward the final grade. In class, students use the software in test mode and discuss multiple-choice questions from both the software and researcher-made tests (knowledge and cognitive performance) in groups of 3–4. Questions are provided on paper and projected, with 5 minutes per question. The instructor asks students to explain their answers and reasoning and clarifies doubts.The Touch Surgery software has two modes: learning mode, which provides step-by-step instructions and interaction via swiping, and test mode, which allows self-assessment and continues the simulation based on interactive responses. The program is not available offline but is simple and professional to use.Post-class activities: Discussions and follow-ups on topics not fully covered in class are held one week later in-person. The post-test is conducted during this session to assess students’ learning. Intervention 2: Control group: This group must also receive prior preparations (the first session on gallbladder anatomy and laparoscopic instruments) before the main educational intervention (the second session on laparoscopic cholecystectomy training). In this group, the instructor provides the educational content containing the laparoscopic cholecystectomy material from the Touch Surgery software in a translated and voice-over PowerPoint file and asks students to study this material before attending the in-person class (the PowerPoint content is identical in both groups).To increase students’ motivation to study the course content, a short quiz including a few questions will be held at the beginning of the in-person session, and its score will be considered as part of the final semester grade. In the in-person class, the multiple-choice questions from the Touch Surgery software test module will be provided to students on paper, along with the researcher-made tests. The instructor asks students, in groups of 3 or 4, to discuss the written multiple-choice test (knowledge domain) and the cognitive performance test. A maximum of 5 minutes will be allocated for each question. Then, the instructor asks students to state their answers for each question and provide explanations for their reasoning. The instructor, as a guide, clarifies any doubts by giving brief explanations.Post-class activities: These include discussion and follow-up on topics and concepts that were not fully covered in the previous session. These discussions will be held in an in-person session one week after the flipped classroom session. Therefore, the post-test will be conducted during this session to assess students’ learning. No - There is not a plan to make this available Justification or reason for not sharing IPD is Consultation with other research members
public Sepideh Totonchilar
Saadi Blvd
Ardabil Iran (Islamic Republic of) 5615751147 +98 45 3372 6085 sepidehtotonchi477@gmail.com Ardabil University of Medical Sciences scientific sepideh totonchilar
Saadi Blvd
Ardabil Iran (Islamic Republic of) 5615751147 +98 45 3372 6085 sepidehtotonchi477@gmail.com Ardabil University of Medical Sciences Iran (Islamic Republic of) Full consent to participate in the study. Own mobile phones capable of installing the touch surgery software and connected to the internet. Participation in the anatomy of the digestive system course and the laparoscopic tools training by a tutor. no limit no limit Both Prior experience with the touch surgery simulator software or similar simulators. Behavior Behavior Intervention group: This group must receive prior preparations (the first session on gallbladder anatomy and laparoscopic instruments) before the main educational intervention (the second session on laparoscopic cholecystectomy training). Before attending the in-person class, students are asked to install the Touch Surgery simulator on their phones and observe laparoscopic cholecystectomy in learning mode. Since the software instructions are in English, the researcher provides a translated and voice-over PowerPoint of the surgical steps. Students then attend the in-person class the following day.At the beginning of the class, a short quiz will be held to motivate students, and its score will count toward the final grade. In class, students use the software in test mode and discuss multiple-choice questions from both the software and researcher-made tests (knowledge and cognitive performance) in groups of 3–4. Questions are provided on paper and projected, with 5 minutes per question. The instructor asks students to explain their answers and reasoning and clarifies doubts.The Touch Surgery software has two modes: learning mode, which provides step-by-step instructions and interaction via swiping, and test mode, which allows self-assessment and continues the simulation based on interactive responses. The program is not available offline but is simple and professional to use.Post-class activities: Discussions and follow-ups on topics not fully covered in class are held one week later in-person. The post-test is conducted during this session to assess students’ learning. Control group: This group must also receive prior preparations (the first session on gallbladder anatomy and laparoscopic instruments) before the main educational intervention (the second session on laparoscopic cholecystectomy training). In this group, the instructor provides the educational content containing the laparoscopic cholecystectomy material from the Touch Surgery software in a translated and voice-over PowerPoint file and asks students to study this material before attending the in-person class (the PowerPoint content is identical in both groups).To increase students’ motivation to study the course content, a short quiz including a few questions will be held at the beginning of the in-person session, and its score will be considered as part of the final semester grade. In the in-person class, the multiple-choice questions from the Touch Surgery software test module will be provided to students on paper, along with the researcher-made tests. The instructor asks students, in groups of 3 or 4, to discuss the written multiple-choice test (knowledge domain) and the cognitive performance test. A maximum of 5 minutes will be allocated for each question. Then, the instructor asks students to state their answers for each question and provide explanations for their reasoning. The instructor, as a guide, clarifies any doubts by giving brief explanations.Post-class activities: These include discussion and follow-up on topics and concepts that were not fully covered in the previous session. These discussions will be held in an in-person session one week after the flipped classroom session. Therefore, the post-test will be conducted during this session to assess students’ learning. Students’ learning in the operating room: In this study, knowledge refers to the score that the individual obtains from the researcher-made test “Assessment of the level of students’ knowledge of laparoscopic cholecystectomy surgery” and “Assessment of cognitive performance in laparoscopic cholecystectomy.” The knowledge assessment test consists of 20 questions. The minimum score is zero and the maximum score is 20. The cognitive performance assessment test consists of 8 scenario-based questions in the stages of laparoscopic cholecystectomy, with a minimum score of zero and a maximum score of 8. Timepoint: To measure the progress of students’ learning, the knowledge and cognitive performance tests will be administered in two stages, before and after the implementation of the intervention (with a two-week interval). Method of measurement: Researcher-made written test “Assessment of students’ level of knowledge of laparoscopic cholecystectomy surgery”: It consists of twenty multiple-choice questions. The minimum score will be zero and the maximum score will be 20.Researcher-made cognitive performance assessment test (with 8 scenario-based questions) in the stages of laparoscopic cholecystectomy surgery: The minimum score will be zero and the maximum score will be 8. Motivation: In this study, “motivation” refers to the score obtained by the individual on the Teaching Motivation Questionnaire (CIS). Timepoint: At the end of the class. Method of measurement: At the end of the class, the Teaching Motivationality Questionnaire (CIS): The described scale assesses learners’ motivation toward teaching and informs about their interests in the four components of attention, connectedness, trust, and satisfaction. This instrument comprises a total of 34 items on a 5-point Likert scale. The score range of this questionnaire is from 34 to 170 (with a median of 102), and a higher score indicates greater interest in the subject and, consequently, greater motivation. Ardabil University of Medical Sciences Approved 2025-08-26 Research Ethics Committees of Ardabil University of Medical Sciences Ardabil Ardabil Ardabil Iran (Islamic Republic of)