UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055985 |
|---|---|
| Receipt number | R000063986 |
| Scientific Title | Educative Effectiveness of Immersive Virtual Reality with 3D Images on Invasive Procedures |
| Date of disclosure of the study information | 2024/10/30 |
| Last modified on | 2025/04/30 10:11:42 |
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Basic information
Public title
Investigating the Educative Effectiveness of Immersive Virtual Reality with 3D Images on Invasive Procedures
Acronym
Investigating the Effectiveness of Immersive Virtual Reality on Medical Education
Scientific Title
Educative Effectiveness of Immersive Virtual Reality with 3D Images on Invasive Procedures
Scientific Title:Acronym
Investigating the Effectiveness of Immersive Virtual Reality on Medical Education
Region
| Japan |
Condition
Condition
Acute illness, Trauma
Classification by specialty
| Operative medicine | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effectiveness of a 3D video material reproduction of a tracheal intubation procedure using an immersive virtual reality experience device terminal on medical students. This study aims to clarify whether comparing 3D and 2D virtual reality experiences improves students' understanding of tracheal intubation procedures. Our hypothesis is that students with no previous experience with the procedure will understand the intubation procedure in 3D and be able to safely perform the procedure in a future clinical setting.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Test to assess knowledge of tracheal intubation techniques
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Viewing a video of a tracheal intubation procedure in 3D and 2D on Apple Vision Pro, in that order.
Interventions/Control_2
Viewing a video of a tracheal intubation procedure in 2D and 3D on Apple Vision Pro, in that order.
Interventions/Control_3
Viewing a video of a tracheal intubation procedure in 3D and 2D on Meta Quest 3, in that order.
Interventions/Control_4
Viewing a video of a tracheal intubation procedure in 2D and 3D on Meta Quest 3, in that order.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Medical students with basic knowledge of tracheal intubation techniques
Key exclusion criteria
Having previous experience with 3D devices, or having significant visual or hearing impairments
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | |
| Last name | Sato |
Organization
Keio University School of Medicine
Division name
Emergency and Critical Care Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0332251323
yukiosato.a6@keio.jp
Public contact
Name of contact person
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Takatsume |
Organization
Keio University School of Medicine
Division name
Anatomy
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
Homepage URL
tsume@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency (JST)
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
Keio University School of Medicine, Institutional Review Board
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
0333531211
med-rinri-jimu@adst.keio.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
| 2024 | Year | 10 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2024 | Year | 10 | Month | 29 | Day |
Last modified on
| 2025 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063986
