UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060742 |
|---|---|
| Receipt number | R000069470 |
| Scientific Title | Randomized controlled trial of virtual reality-based conversational simulation training to improve collaborative communication during cardiopulmonary bypass |
| Date of disclosure of the study information | 2026/02/25 |
| Last modified on | 2026/02/25 13:39:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
VR Cardiac Surgery Team Training Study
Acronym
Study on the educational effectiveness of VR-based team training for cardiac surgery
Scientific Title
Randomized controlled trial of virtual reality-based conversational simulation training to improve collaborative communication during cardiopulmonary bypass
Scientific Title:Acronym
VR-CPB Communication RCT
Region
| Japan |
Condition
Condition
Simulation-based training for cardiopulmonary bypass management (no specific disease)
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare VR-based conversational training, conventional equipment-based training, and combined training in a simulated cardiopulmonary bypass scenario and to evaluate their effects on collaborative communication skills. The primary outcome is the objective scenario progress collaboration score (OPS).
Basic objectives2
Others
Basic objectives -Others
To compare the educational effects of VR-based conversational training, conventional equipment training, and combined training in a simulated cardiopulmonary bypass scenario.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Objective Scenario Progress Collaboration Score (OPS) during the test session
Key secondary outcomes
Organizational Communication Quotient Points (CQP)
Subjective Collaborative Communication Score (SCS)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Simulation training using actual cardiopulmonary bypass equipment. Each session lasts approximately 15 minutes and is conducted 3 times.
Interventions/Control_2
Training using a virtual reality based conversational simulation system. Each session lasts approximately 15 minutes and is conducted 3 times.
Interventions/Control_3
Combined simulation training using both actual equipment and virtual reality. Each session lasts approximately 15 minutes and is conducted 3 times.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Students enrolled in a clinical engineering training program who provided written informed consent
Key exclusion criteria
Individuals at risk of physical discomfort during VR use
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Ryosuke |
| Middle name | |
| Last name | Kasai |
Organization
Tokyo University of Technology
Division name
Department of Clinical Engineering, School of Health Sciences
Zip code
144-8535
Address
5-23-22, Nishikamata, Otaku, Tokyo, Japan
TEL
0364242189
ryo.n315@icloud.com
Public contact
Name of contact person
| 1st name | Ryosuke |
| Middle name | |
| Last name | Kasai |
Organization
Tokyo University of Technology
Division name
Department of Clinical Engineering, School of Health Sciences
Zip code
144-8535
Address
5-23-22, Nishi-Kamata, Ota-ku, Tokyo, Japan
TEL
0364242189
Homepage URL
ryo.n315@icloud.com
Sponsor or person
Institute
Tokyo University of Technology
Institute
Department
Personal name
Ryosuke Kasai
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS) KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Tokyo University of Technology
Address
1404-1 Katakura-machi, Hachioji, Tokyo 192-0982, Japan
Tel
042-637-2111
aizawa@stf.teu.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
O-taku
Institutions
Institutions
東京工科大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 25 | 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
36
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
Completed
Date of protocol fixation
| 2024 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2026 | Year | 02 | Month | 25 | Day |
Last modified on
| 2026 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069470
