UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062392 |
|---|---|
| Receipt number | R000071363 |
| Scientific Title | A multicenter prospective randomized controlled trial evaluating two-dimensional versus virtual reality educational videos for radiotherapy education among patients and medical students |
| Date of disclosure of the study information | 2026/07/30 |
| Last modified on | 2026/07/29 19:18:17 |
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Basic information
Public title
A multicenter prospective randomized controlled study evaluating two-dimensional and virtual reality educational videos for radiotherapy education
Acronym
2D versus VR Video-Based Education for Radiotherapy
Scientific Title
A multicenter prospective randomized controlled trial evaluating two-dimensional versus virtual reality educational videos for radiotherapy education among patients and medical students
Scientific Title:Acronym
2DvsVR-RT
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to create 2D and VR videos explaining the basics of radiotherapy and to compare and evaluate their educational effectiveness among patients and medical students. For patients, we will assess their level of understanding of radiotherapy, anxiety levels, and satisfaction. For medical students, we will evaluate their level of understanding, the educational effectiveness of the videos, and their interest in radiotherapy. Additionally, we will conduct a comparative evaluation of the 2D and VR videos across both groups to examine the usefulness and appropriate applications of VR educational materials.
Basic objectives2
Others
Basic objectives -Others
This study is expected to clarify the characteristics and effectiveness of both 2D videos and VR videos in radiotherapy explanations. While VR videos offer the advantage of high immersion and an intuitive understanding of the treatment environment, they are subject to operational constraints such as equipment setup and the number of viewers. By identifying the patient groups for whom VR videos are effective and those for whom 2D videos are sufficient, this study is expected to lead to the efficient and practical use of video materials in patient counseling and medical education.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Level of understanding regarding radiotherapy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
60 patients undergoing radiotherapy
Interventions/Control_2
60 medical students
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients
1. Aged 18 years or older.
2. Scheduled to undergo external beam radiotherapy for the first time.
3. Provided written informed consent after receiving a full explanation of the study.
4. Able to complete the study questionnaires.
Medical Students
1. Enrolled as a medical student.
2. Provided written informed consent after receiving a full explanation of the study.
3. Able to complete the study questionnaires.
Key exclusion criteria
Patients
1. Difficulty wearing a VR headset.
2. Visual or hearing impairment that precludes viewing the educational videos.
3. Unable to understand the study or complete the study questionnaires.
4. Poor physical condition at the time of participation.
Medical Students
1. Difficulty wearing a VR headset.
2. Visual or hearing impairment that precludes viewing the educational videos.
3. Unable to understand the study or complete the study questionnaires.
4. Poor physical condition at the time of participation.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hirofumi |
| Middle name | |
| Last name | Toyama |
Organization
Keio University School of Medicine
Division name
Department of Radiology
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0353633835
hirotoya7@keio.jp
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Toyama |
Organization
Keio University School of Medicine
Division name
Department of Radiology
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0353633835
Homepage URL
hirotoya7@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Radiology, Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
0353633835
hirotoya7@keio.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 | 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
| 2026 | Year | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2030 | 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 | 07 | Month | 29 | Day |
Last modified on
| 2026 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071363
