UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062050 |
|---|---|
| Receipt number | R000070084 |
| Scientific Title | Comparison of the Educational Effects of Virtual Reality and Augmented Reality Learning Materials in Cricothyrotomy Education for Medical Students: A Prospective Interventional Study |
| Date of disclosure of the study information | 2026/07/01 |
| Last modified on | 2026/06/24 20:12:05 |
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Basic information
Public title
A Prospective Interventional Study Comparing the Educational Effects of Virtual Reality (VR) and Augmented Reality (AR) Learning Materials in Cricothyrotomy Training for Medical Students
Acronym
VR/AR Cricothyrotomy Education Trial
Scientific Title
Comparison of the Educational Effects of Virtual Reality and Augmented Reality Learning Materials in Cricothyrotomy Education for Medical Students: A Prospective Interventional Study
Scientific Title:Acronym
VRAR-CricEdu
Region
| Japan |
Condition
Condition
Upper airway obstruction
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to compare the educational effects of VR-based materials created from cadaveric specimens and AR-based materials created from CT-derived models with those of conventional lecture-based education, and to clarify their impact on skill acquisition in cricothyrotomy, thereby contributing to the future direction of educational material development in emergency medicine.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Time required to perform cricothyrotomy (seconds)
Key secondary outcomes
Deviation distance of the incision site from the midline (mm)
Vertical accuracy of the incision site (deviation in height)
Educational satisfaction (5-point questionnaire: numeric rating scale)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Educational intervention using VR-based, AR-based, and lecture-based learning materials
Interventions/Control_2
VR education group. In addition to the standardized lecture, participants undergo training using VR learning materials created from cadaveric procedure videos.
Interventions/Control_3
AR education group. In addition to the standardized lecture, participants undergo training using AR learning materials of the larynx created from CT images.
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Medical students in the 4th to 6th years at our medical school who are participating in clinical clerkship, understand the purpose of this study, and provide written informed consent.
Key exclusion criteria
Participants who do not meet the inclusion criteria.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Tadahiro |
| Middle name | |
| Last name | Kobayashi |
Organization
Yamagata University, Faculty of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
990-9585
Address
2-2-2 Iida-Nishi, Yamagata, Yamagata-pref, Japan
TEL
023-628-5422
ta-kobayashi@med.id.yamagata-u.ac.jp
Public contact
Name of contact person
| 1st name | Tadahiro |
| Middle name | |
| Last name | Kobayashi |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
990-9585
Address
2-2-2 Iida-Nishi, Yamagata, Yamagata-pref, Japan
TEL
023-628-5422
Homepage URL
ta-kobayashi@med.id.yamagata-u.ac.jp
Sponsor or person
Institute
Yamagata University
Institute
Department
Personal name
Funding Source
Organization
Yamagata University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamagata University Faculty of Medicine Ethics Committee
Address
2-2-2 Iida-Nishi, Yamagata, 990-9585, Japan
Tel
023-628-5047
yu-ikekenkyu@jm.kj.yamagata-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 | 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
| 2025 | Year | 09 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2028 | 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 | 06 | Month | 24 | Day |
Last modified on
| 2026 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070084
