UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062522 |
|---|---|
| Receipt number | R000071570 |
| Scientific Title | Effect of a Mobile-Based Cognitive Simulator (Touch Surgery) on Knowledge, Simulated Scrub-Role Performance, and Perceived Perioperative Competence among Operating Room Technology Students: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/08/08 |
| Last modified on | 2026/08/08 02:17:05 |
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Basic information
Public title
Effect of Touch Surgery Mobile Simulator on Knowledge, Simulated Clinical Performance, and Perceived Perioperative Competence among Operating Room Technology Students
Acronym
TS-ORT Trial
Scientific Title
Effect of a Mobile-Based Cognitive Simulator (Touch Surgery) on Knowledge, Simulated Scrub-Role Performance, and Perceived Perioperative Competence among Operating Room Technology Students: A Randomized Controlled Trial
Scientific Title:Acronym
TS-ORT Trial
Region
| Asia(except Japan) |
Condition
Condition
Undergraduate operating room technology students
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Simulated scrub-role performance assessed using a 20-item procedure-specific observational checklist with a total score of 0-40 in the Clinical Skills Laboratory. Assessments were performed at baseline, immediately after completion of the intervention, and at 4-week follow-up.
Key secondary outcomes
Procedure-specific knowledge, assessed using a 25-item multiple-choice Laparoscopic Cholecystectomy Knowledge Assessment Test, at baseline, immediately after the intervention, and at the 4-week follow-up.
Perceived perioperative competence, assessed using the 33-item Perceived Perioperative Competence Scale-Revised (PPCS-R), at baseline, immediately after the intervention, and at the 4-week follow-up.
Safety attitudes, assessed using the 30-item Safety Attitudes Questionnaire (SAQ), at baseline, immediately after the intervention, and at the 4-week follow-up.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Seyed Abolfazl |
| Middle name | |
| Last name | Hosseini |
Organization
Golestan University of Medical Sciences
Division name
Department of Surgical Technology, Faculty of Paramedical Sciences
Zip code
4918936316
Address
Faculty of Paramedical Sciences, Golestan University of Medical Sciences, Gorgan-Sari Road, Gorgan, Golestan Province, Iran
TEL
+981732430310
hosseinia1377@gmail.com
Public contact
Name of contact person
| 1st name | Seyed Abolfazl |
| Middle name | |
| Last name | Hosseini |
Organization
Golestan University of Medical Sciences
Division name
Department of Surgical Technology, Faculty of Paramedical Sciences
Zip code
4918936316
Address
Faculty of Paramedical Sciences, Golestan University of Medical Sciences, Gorgan-Sari Road, Gorgan,
TEL
+981732430310
Homepage URL
https://goums.ac.ir
hosseinia1377@gmail.com
Sponsor or person
Institute
Birjand University of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Self-funded by the investigators
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Iran
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Birjand University of Medical Sciences
Address
Birjand University of Medical Sciences, Ghaffari Street, Birjand, South Khorasan, Iran
Tel
+985632395000
public-r@bums.ac.ir
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Birjand University of Medical Sciences, Faculty of Paramedical Sciences and Clinical Skills Laboratory (Birjand, South Khorasan, Iran)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 08 | Day |
Related information
URL releasing protocol
Protocol is not publicly available.
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
80
Results
Among 80 randomized students, Touch Surgery plus standard training produced greater improvements than standard training alone in simulated scrub-role performance (Time x Group P<0.001, partial eta2=0.195), knowledge (P<0.001, eta2=0.147), and perceived perioperative competence (P<0.001, eta2=0.269). No significant differential change was observed in safety attitudes (P=0.373, eta2=0.013). All 80 participants completed follow-up and were analyzed.
Results date posted
| 2026 | Year | 08 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 80 undergraduate operating room technology students were randomized, with 40 participants in each group. In the control group, mean age was 21.71 +/- 1.03 years, 26 participants (65.0%) were female and 14 (35.0%) were male, mean GPA was 16.33 +/- 1.02, 27 (67.5%) had prior limited exposure to laparoscopic surgery, and mean instrument familiarity score was 2.48 +/- 0.81. In the intervention group, mean age was 21.42 +/- 1.14 years, 23 participants (57.5%) were female and 17 (42.5%) were male, mean GPA was 16.54 +/- 0.91, 29 (72.5%) had prior limited exposure, and mean instrument familiarity score was 2.68 +/- 0.76. No statistically significant baseline differences were observed between the groups.
Participant flow
A total of 80 participants were randomized: 40 to Touch Surgery plus standard training and 40 to standard training alone. All 40 participants in each group received the intended intervention or control condition and completed the immediate post-test and 4-week follow-up assessments. There were no withdrawals, losses to follow-up, or exclusions after randomization. All 80 randomized participants were included in the intention-to-treat analysis.
Adverse events
No adverse events, unintended effects, or significant technical failures were reported during the intervention or follow-up period.
Outcome measures
Primary outcome - Simulated scrub-role performance: Control group scores were 22.43 +/- 6.60 at baseline, 27.23 +/- 5.05 immediately after the intervention, and 26.47 +/- 6.34 at 4-week follow-up. Touch Surgery group scores were 22.13 +/- 6.76, 32.38 +/- 4.40, and 31.45 +/- 4.84, respectively. The Time x Group interaction was significant, F(1.85,144.81)=18.93, P<0.001, partial eta2=0.195. The post-test between-group mean difference was 5.15 points, 95% CI 3.04 to 7.26, with Cohen's d=1.08.
Secondary outcome - Procedure-specific knowledge: Control group scores were 12.88 +/- 4.80 at baseline, 15.35 +/- 4.36 at post-test, and 16.02 +/- 4.14 at follow-up. Touch Surgery group scores were 12.65 +/- 4.82, 18.95 +/- 3.78, and 19.03 +/- 4.11, respectively. The Time x Group interaction was significant, F(1.77,138.21)=13.43, P<0.001, partial eta2=0.147. The post-test between-group mean difference was 3.60 points, 95% CI 1.78 to 5.42, with Cohen's d=0.88.
Secondary outcome - Perceived perioperative competence: Control group PPCS-R scores were 98.25 +/- 20.31 at baseline, 103.05 +/- 20.81 at post-test, and 102.77 +/- 20.66 at follow-up. Touch Surgery group scores were 96.63 +/- 19.89, 116.67 +/- 19.14, and 114.05 +/- 20.29, respectively. The Time x Group interaction was significant, F(2,156)=28.71, P<0.001, partial eta2=0.269. The post-test between-group mean difference was 13.62 points, 95% CI 4.72 to 22.53, with Cohen's d=0.68.
Secondary outcome - Safety attitudes: Control group SAQ scores were 100.80 +/- 17.00 at baseline, 101.15 +/- 15.94 at post-test, and 103.98 +/- 15.06 at follow-up. Touch Surgery group scores were 99.53 +/- 11.40, 102.60 +/- 14.32, and 102.35 +/- 13.88, respectively. The Time x Group interaction was not statistically significant, F(2,156)=0.99, P=0.373, partial eta2=0.013.
Plan to share IPD
Yes, upon reasonable request.
IPD sharing Plan description
De-identified individual participant data underlying the reported results may be made available from the corresponding author upon reasonable request, subject to applicable ethical, institutional, and data-protection requirements. No unrestricted public release of individual participant data is planned.
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 08 | Day |
Last modified on
| 2026 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071570
