UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062798 |
|---|---|
| Receipt number | R000071836 |
| Scientific Title | Effectiveness of Pre-Learning Videos in Robotic Surgery Simulator Training for Medical Students During Clinical Clerkship: A Prospective Non-Randomized Interventional Study |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/08/30 13:10:49 |
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Basic information
Public title
Effectiveness of Pre-Learning Videos in Robotic Surgery Simulator Training for Medical Students: A Prospective Non-Randomized Interventional Study
Acronym
Robotic Surgery Simulator Training for Medical Students
Scientific Title
Effectiveness of Pre-Learning Videos in Robotic Surgery Simulator Training for Medical Students During Clinical Clerkship: A Prospective Non-Randomized Interventional Study
Scientific Title:Acronym
Pre-Learning Video Study for Robotic Surgery Simulator Training
Region
| Japan |
Condition
Condition
Not applicable (healthy participants)
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of pre-learning videos on training efficiency and educational outcomes in robotic surgery simulator training for medical students during clinical clerkship.
Basic objectives2
Others
Basic objectives -Others
To evaluate the effects of pre-learning videos on instruction time, simulator performance, training satisfaction, self-efficacy, and interest in robotic surgery.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of the time required for robotic surgery simulator instruction between the pre-learning video group and the control group
Key secondary outcomes
Simulator task performance, total training time, changes in interest in robotic surgery, urology, and surgical specialties, self-assessment and self-efficacy regarding simulator operation, understanding and performance of basic da Vinci operations (clutch, camera, and foot pedal controls), training satisfaction, evaluation of training duration, and the perceived usefulness and viewing status of the pre-learning video.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Participants watch an approximately 10-minute pre-learning video on the basic operation of the da Vinci surgical simulator before their first simulator training session.
Interventions/Control_2
Participants do not watch the pre-learning video before the first robotic surgery simulator training session and receive standard verbal instruction on the day of the training. After the first session, they watch the same approximately 10-minute video as the intervention group for review and preparation for the second session.
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
Medical students participating in the urology clinical clerkship at Wakayama Medical University who provide written informed consent to participate in this study.
Key exclusion criteria
Students who do not provide informed consent to participate in the study, or who are considered unsuitable for participation by the principal investigator or other investigators.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Kohjimoto |
Organization
Wakayama Medical University
Division name
Urology
Zip code
641-0012
Address
811-1 Kimiidera, Wakayama, Wakayama
TEL
0734410637
0911yuya@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuya |
| Middle name | |
| Last name | Iwahashi |
Organization
Wakayama Medical University
Division name
Urology
Zip code
6410012
Address
811-1 Kimiidera, Wakayama, Wakayama
TEL
0734410637
Homepage URL
yuya09114694@gmail.com
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Yuya Iwahashi
Funding Source
Organization
Wakayama Medical University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama, Wakayama
Tel
0734472300
wa-rinri@wakayama-med.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 10 | Month | 01 | 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 | 09 | Month | 03 | Day |
Last modified on
| 2026 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071836
