UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053111 |
|---|---|
| Receipt number | R000060610 |
| Scientific Title | A pilot study on suitable configurations and interfaces for a universally designed medical metaverse VR system |
| Date of disclosure of the study information | 2023/12/15 |
| Last modified on | 2023/12/15 00:13:12 |
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Basic information
Public title
A pilot study on suitable configurations and interfaces for a universally designed medical metaverse VR system
Acronym
A pilot study on a universal design medical metaverse VR system
Scientific Title
A pilot study on suitable configurations and interfaces for a universally designed medical metaverse VR system
Scientific Title:Acronym
A pilot study on a universal design medical metaverse VR system
Region
| Japan |
Condition
Condition
No specific regulations
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to explore and clarify the interface and configuration (universal design medical metaverse VR system) that will make the system easy to use and attachment-friendly for many people, including the late elderly, patients/caregivers, and medical personnel (patient's supporters).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the subject response Numerical Rating Scale (NRS) for "fun," "familiarity," "immersion," "ease of use," "anticipation (excitement)," "nausea," "headache," "dizziness," "other adverse reactions," etc., between systems.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The subjects were asked to select a video to view from a list of videos. After viewing the approximately 3-minute video and experiencing one of three randomly selected types of VR systems, subjects were asked to respond to NRSs about "enjoyment," "familiarity," "immersion," "ease of use," "anticipation (excitement)," "nausea," "headache," "dizziness," "other adverse reactions," and so on.
Interventions/Control_2
From the list of videos, subjects were asked to select a video to view. After viewing the approximately 3-minute video and experiencing another one of the three randomly selected types of VR systems, subjects will be asked to respond to NRSs about "enjoyment," "familiarity," "immersion," "ease of use," "anticipation (excitement)," "nausea," "headache," "dizziness," "other adverse reactions," and so on.
Interventions/Control_3
From the list of videos, subjects were asked to select a video to view. After viewing the approximately 3-minute video and experiencing another one of the three randomly selected types of VR systems, subjects will be asked to respond to NRSs about "enjoyment," "familiarity," "immersion," "ease of use," "anticipation (excitement)," "nausea," "headache," "dizziness," "other adverse reactions," and so on.
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
Must be at least 18 years of age.
Able to answer the questionnaire in writing or orally.
Able to communicate orally.
Key exclusion criteria
Those who are under 18 years old.
Those who have cognitive decline to the extent that they cannot respond to the questionnaire, or those who have been diagnosed with dementia.
Those who have difficulty in oral communication.
Those with visual impairment
Those with hearing impairment
Those who are judged by the physician to be unsuitable to participate in this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Okamoto |
Organization
Ashiya Municipal Hospital
Division name
Pharmacy
Zip code
659-8502
Address
39-1, Asahigaoka-cho, Ashiya, Hyogo
TEL
0797-31-2156
yoshiakiokamoto3@ybb.ne.jp
Public contact
Name of contact person
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Niki |
Organization
Ashiya Municipal Hospital
Division name
Pharmacy
Zip code
659-8502
Address
39-1, Asahigaoka-cho, Ashiya, Hyogo
TEL
0797-31-2156
Homepage URL
k-niki@phs.osaka-u.ac.jp
Sponsor or person
Institute
Ashiya Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ashiya Municipal Hospital
Address
39-1, Asahigaoka-cho, Ashiya, Hyogo
Tel
0797-31-2156
k-niki@phs.osaka-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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 12 | Month | 15 | Day |
Last modified on
| 2023 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060610
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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