UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062218 |
|---|---|
| Receipt number | R000071200 |
| Scientific Title | Clinical trainees' teaching of preoperative hand scrubbing and gowning techniques is non-inferior to faculty members: a randomized controlled trial |
| Date of disclosure of the study information | 2026/07/12 |
| Last modified on | 2026/07/12 18:02:46 |
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Basic information
Public title
Clinical trainees' teaching of preoperative hand scrubbing and gowning techniques is non-inferior to faculty members: a randomized controlled trial
Acronym
Clinical trainees' teaching of preoperative hand scrubbing and gowning techniques is non-inferior to faculty members: a randomized controlled trial
Scientific Title
Clinical trainees' teaching of preoperative hand scrubbing and gowning techniques is non-inferior to faculty members: a randomized controlled trial
Scientific Title:Acronym
Clinical trainees' teaching of preoperative hand scrubbing and gowning techniques is non-inferior to faculty members: a randomized controlled trial
Region
| Japan |
Condition
Condition
preoperative hand scrubbing and gowning techniques
Classification by specialty
| Medicine in general | Cardiology | Nephrology |
| Infectious disease | Surgery in general | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Vascular surgery | Chest surgery |
| Endocrine surgery | Breast surgery | Obstetrics and Gynecology |
| Ophthalmology | Dermatology | Oto-rhino-laryngology |
| Orthopedics | Urology | Oral surgery |
| Neurosurgery | Cardiovascular surgery | Plastic surgery |
| Operative medicine | Emergency medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We hypothesized that, for relatively standardized clinical procedures such as preoperative hand scrubbing and gowning techniques, instruction provided by clinical trainees with real-world clinical experience may contribute to learners' procedural skill acquisition. Therefore, this study aimed to evaluate whether instruction in preoperative hand scrubbing and gowning techniques provided by fifth-year medical students during their clinical clerkships was non-inferior to instruction provided by faculty members for fourth-year medical students immediately before the start of their clerkships. In Japan, preoperative hand scrubbing and gowning techniques are core clinical procedures that all medical students and residents are expected to perform and are considered to have substantial educational value. Demonstrating the non-inferiority of instruction provided by clinical trainees would support the integration of PAL into the formal curriculum for these procedures and may contribute to reducing faculty workload and promoting physician workstyle reforms, thereby providing substantial societal value.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The total proficiency assessment score on the preoperative hand scrubbing and gowning techniques
Key secondary outcomes
Individual item scores
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants were allocated to one of two groups: a group receiving instruction from fifth-year medical students during their clinical clerkships (SATs group) and a group receiving instruction from faculty members (faculty group). The SAT group served as the intervention group. All participants participated in the "preoperative hand scrubbing and gowning technique training session (90 minuites)" and instructed by each instructor. All instructors were provided with standardized instructional materials on preoperative hand scrubbing and gowning techniques before the training session. All instructions were delivered in accordance with these materials. The materials covered communication with the assistant; hand scrubbing procedures and the area (three cycles in total); drying scrubbed hands with sterile towels; application of an alcohol-based solution; receiving and unfolding a gown with an integrated mask; gowning procedures including receiving mask strings, sleeve insertion, mask application, and transfer of waist ties; receiving and donning sterile gloves; and gown removal.
Interventions/Control_2
The faculty group served as the control group. All participants participated in the "preoperative hand scrubbing and gowning technique training session (90 minuites)" and instructed by each instructor. All instructors were provided with standardized instructional materials on preoperative hand scrubbing and gowning techniques before the training session. All instructions were delivered in accordance with these materials. The materials covered communication with the assistant; hand scrubbing procedures and the area (three cycles in total); drying scrubbed hands with sterile towels; application of an alcohol-based solution; receiving and unfolding a gown with an integrated mask; gowning procedures including receiving mask strings, sleeve insertion, mask application, and transfer of waist ties; receiving and donning sterile gloves; and gown removal.
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
| 18 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Fourth-year medical students, prior to the start of their clinical clerkships, who participated in the "preoperative hand scrubbing and gowning technique training session" conducted on March 23, 2026, and the subsequent proficiency assessment test conducted on March 27, 2026, were included.
Key exclusion criteria
The exclusion criterion was refusal to provide consent for study participation.
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | Shun |
| Middle name | |
| Last name | Yamashita |
Organization
Faculty of Medicine, Saga University
Division name
Education and Research Center for Community Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga, Japan
TEL
0952342249
sy.hospitalist.japan@gmail.com
Public contact
Name of contact person
| 1st name | Shun |
| Middle name | |
| Last name | Yamashita |
Organization
Faculty of Medicine, Saga University
Division name
Education and Research Center for Community Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga, Japan
TEL
0952342249
Homepage URL
https://www.med.saga-u.ac.jp/structure/research/information/
sy.hospitalist.japan@gmail.com
Sponsor or person
Institute
Education and Research Center for Community Medicine, Faculty of Medicine, Saga University, Saga, Japan
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Medicine, Saga University
Address
5-1-1 Nabeshima, Saga 849-8501, Japan
Tel
0952-34-3400
medsosou1@mail.admin.saga-u.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 | 07 | Month | 12 | 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
97
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2029 | Year | 03 | 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 | 07 | Month | 12 | Day |
Last modified on
| 2026 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071200
