Tokyo, Aug. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062522) titled 'Effect of Touch Surgery Mobile Simulator on Knowledge, Simulated Clinical Performance, and Perceived Perioperative Competence among Operating Room Technology Students' on Aug. 8.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - Birjand University of Medical Sciences
Condition:
Condition - Undergraduate operating room technology students
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effectiveness of adding the Touch Surgery mobile-based cognitive simulator to conventional training, compared with conventional training alone, on simulated scrub-role performance, procedure-specific knowledge, perceived perioperative competence, and safety attitudes among undergraduate operating room technology students undergoing laparoscopic cholecystectomy training.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Intervention group: Participants received the standard faculty-approved training for laparoscopic cholecystectomy plus simulator-based training using the Touch Surgery mobile application. The Touch Surgery training consisted of three 45-minute self-directed practice sessions over one week. Participants completed all five stages of the Laparoscopic Cholecystectomy module on their personal smartphone or tablet. A research assistant was available for technical support and adherence monitoring.
Interventions/Control_2 - Control group: Participants received only the standard faculty-approved training for laparoscopic cholecystectomy, consisting of theoretical teaching followed by practical orientation in the Clinical Skills Laboratory. No additional cognitive simulator or digital training platform was provided.
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Undergraduate student enrolled in the Operating Room Technology Bachelor of Science program in semesters 4-6.
2. Provision of written informed consent.
3. No previous use of Touch Surgery or a similar surgical simulation application.
4. No previous formal training or extensive observational experience in laparoscopic cholecystectomy.
5. Access to a smartphone or tablet and Internet connection.
6. No concurrent training in laparoscopic cholecystectomy elsewhere.
Key exclusion criteria - 1. Insufficient attendance at the training sessions.
2. Incomplete completion of study questionnaires.
3. Failure to adhere to the specified Touch Surgery training protocol.
4. Missing the immediate post-test or 4-week follow-up assessment.
5. Withdrawal of consent or request to leave the study.
Target Size - 80
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 09 Month 01 Day
Date of IRB - 2025 Year 09 Month 20 Day
Anticipated trial start date - 2025 Year 10 Month 01 Day
Last follow-up date - 2025 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071570
Disclaimer: Curated by HT Syndication.