UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050374 |
|---|---|
| Receipt number | R000057355 |
| Scientific Title | Research and development of a VR app for therapists' experiential learning to improve manners |
| Date of disclosure of the study information | 2023/02/17 |
| Last modified on | 2023/02/17 16:25:06 |
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Basic information
Public title
Research and development of a VR app for therapists' experiential learning to improve manners
Acronym
VR app for therapists' experiential learning to improve manners
Scientific Title
Research and development of a VR app for therapists' experiential learning to improve manners
Scientific Title:Acronym
VR app for therapists' experiential learning to improve manners
Region
| Japan |
Condition
Condition
Rehabilitation training school students
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Research and development of a VR application to improve therapists' hospitality/manners and validation of its usefulness
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
After the application experience, a questionnaire will be used to evaluate the level of focus on the experience.
Key secondary outcomes
Sense of reality of the experience
Appropriateness of verbal/nonverbal communication
The attitude of empathic understanding of the therapist
The attitude of empathic understanding of the therapist's position
Consideration for the therapist's explanation
Understanding of the patient's feelings during the experience
Understanding of inappropriate parts of the therapist's interactions
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Experience of the VR app
Interventions/Control_2
Experience the same video content as the VR app
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Rehabilitation training school students
Key exclusion criteria
Nothing
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | MASATO |
| Middle name | |
| Last name | TAKEUCHI |
Organization
Graduate School, The University of Tokyo
Division name
Department of Clinical Information Engineering, Health Service Sciences, School of Public Health, Graduate School of Medicine
Zip code
113-0033
Address
7 Chome-3-1 Hongo, Bunkyo City, Tokyo
TEL
03-3812-2111
cie-office@umin.ac.jp
Public contact
Name of contact person
| 1st name | MASATO |
| Middle name | |
| Last name | TAKEUCHI |
Organization
Graduate School, The University of Tokyo
Division name
Department of Clinical Information Engineering, School of Public Health, Graduate School of Medicine
Zip code
270-0023
Address
7 Chome-9-4 Hachigasaki, Matsudo City, Chiba
TEL
050-3554-3111
Homepage URL
mrx0514@gmail.com
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
MASATO TAKEUCHI
Funding Source
Organization
Nothing
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
Graduate School, The University of Tokyo
Address
7 Chome-9-4 Hachigasaki, Matsudo City, Chiba
Tel
05035543111
mrx0514@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
20222088NI
Org. issuing International ID_1
Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京大学大学院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 17 | 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
46
Results
The VR group showed significantly higher scores in terms of the sense of reality, concentration, understanding of the patient's feelings, and understanding of inappropriate remarks and attitudes of the therapist.
Results date posted
| 2023 | Year | 02 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Students of the Department of Rehabilitation in a four-years university, 38 majors in physical therapy and 8 majors in occupational therapy, totaling 46 students.
Participant flow
Asking faculty members in the rehabilitation departments of four-year universities that to recruit students majoring in physical therapy and occupational therapy.
Adverse events
VR sickness (1 person)
Outcome measures
Focus on the experience
Sense of reality of the experience
Appropriateness of verbal/nonverbal communication
The attitude of empathic understanding of the therapist
The attitude of empathic understanding of the therapist's position
Consideration for the therapist's explanation
Understanding of the patient's feelings during the experience
Understanding of inappropriate parts of the therapist's interactions
Plan to share IPD
Nothing
IPD sharing Plan description
Nothing
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 16 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 16 | Day |
Date trial data considered complete
| 2022 | Year | 11 | Month | 16 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 17 | Day |
Last modified on
| 2023 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057355
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