UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058017 |
|---|---|
| Receipt number | R000066317 |
| Scientific Title | Development of a Support System for Balancing Work and Treatment in Patients with Inflammatory Bowel Disease: An Educational Program for IBD Specialists Using Virtual Reality Training |
| Date of disclosure of the study information | 2025/05/30 |
| Last modified on | 2025/05/29 17:35:05 |
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Basic information
Public title
A Virtual Training Program for IBD Specialists to Promote Work-Treatment Balance in Patients with Inflammatory Bowel Disease
Acronym
IBD Specialist Metaverse Training Project
Scientific Title
Development of a Support System for Balancing Work and Treatment in Patients with Inflammatory Bowel Disease: An Educational Program for IBD Specialists Using Virtual Reality Training
Scientific Title:Acronym
IBD-VR Education Project
Region
| Japan |
Condition
Condition
Not applicable (Educational study for enhancing clinical competence in inflammatory bowel disease)
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to objectively evaluate the effectiveness of a virtual reality-based educational program in improving the clinical competence of physicians involved in IBD care, with the goal of establishing a structured training system for junior IBD specialists.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the effectiveness of the educational program by comparing pre- and post-training clinical competence scores based on self-assessment and expert assessment.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Simulated clinical training using virtual reality (metaverse)
Participating physicians will engage in role-play sessions within a virtual environment using avatars, based on three levels of clinical scenarios in IBD care (standard, moderately difficult, and special cases). Each session lasts 20 minutes, conducted semiannually over a two-year period. Self-assessment and expert evaluations will be conducted after each session.
Interventions/Control_2
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
| 28 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Physicians affiliated with Fukuoka University Hospital or other institutions participating in the IBD-quality team.
Physicians with less than 15 years of clinical experience.
Physicians who meet either of the following:
a. Board-certified internists or gastroenterologists (or those with equivalent experience).
b. Physicians with at least 5 years of practical experience and scheduled to obtain board certification in internal medicine or gastroenterology.
Key exclusion criteria
Individuals who do not provide informed consent to participate in the study.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Ashizuka |
Organization
Fukuoka University Hospital
Division name
Department of Gastroenterology
Zip code
814-0180
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
TEL
0928011011
ashizuka@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Ashizuka |
Organization
Fukuoka University Faculty of Medicine
Division name
Department of Gastroenterology
Zip code
814-0180
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka, Japan
TEL
0928011011
Homepage URL
ashizuka@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
Pfizer
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
the Ethics Review Committee of Fukuoka University Hospital
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka, Japan
Tel
0928011011
rinshou@adm.fukuoka-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
福岡県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 05 | Month | 29 | Day |
Last modified on
| 2025 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066317
