UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049870 |
|---|---|
| Receipt number | R000056691 |
| Scientific Title | The study of a distance learning program using video materials and educational effects - 2D vs. VR randomized controlled trial |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2023/08/24 16:17:02 |
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Basic information
Public title
Study on building a remote clinical practice platform using Virtual Reality
Acronym
Study on building a remote clinical practice platform using Virtual Reality
Scientific Title
The study of a distance learning program using video materials and educational effects - 2D vs. VR randomized controlled trial
Scientific Title:Acronym
The study of a distance learning program using video materials and educational effects
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare VR and 2D videos on distance learning education of Focused Assessment with Sonography for Trauma (FAST) in initial trauma care and to examine learning effects such as self-efficacy and comprehension.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Self-efficacy
Endogenous value
Emotional Engagement
Key secondary outcomes
Subjective Comprehension
Knowledge test
Usability
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
The participants will attend an educational program using VR video materials on initial trauma care, including FAST in real-world clinical practice. The educational program will last approximately 30 minutes.
Interventions/Control_2
The participants will attend an educational program using 2D video materials on initial trauma care, including FAST in real-world clinical practice. The educational program will last approximately 30 minutes.
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The objects must be 4th to 6th year medical students or 1st or 2nd year initial residents of the medical school of the participating institution, and healthy both mentally and physically.
Key exclusion criteria
No consent to participate in the study
Those who have difficulty continuing the intervention.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shoji |
| Middle name | |
| Last name | Yokobori |
Organization
Nippon Medical School Hospital
Division name
Emergency department
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
shoji@nms.ac.jp
Public contact
Name of contact person
| 1st name | Koshi |
| Middle name | |
| Last name | Nakagawa |
Organization
Kokushikan University Graduate School
Division name
Department of Emergency Medical System
Zip code
206-8515
Address
7-3-1, Nagayama, Tama-City, Tokyo, Japan
TEL
042-339-7200
Homepage URL
koshi5461@gmail.com
Sponsor or person
Institute
Other
Institute
Department
Personal name
Shoji Yokobori
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School Hospital
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan
Tel
03-3822-2131
shoji@nms.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
| 2023 | Year | 01 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 28 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 12 | Month | 22 | Day |
Last modified on
| 2023 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056691
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
