UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055451 |
|---|---|
| Receipt number | R000063361 |
| Scientific Title | A subjective workload evaluation of augmented reality display of X-ray scattered dose using a glasses-type device |
| Date of disclosure of the study information | 2024/09/13 |
| Last modified on | 2024/11/01 16:52:33 |
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Basic information
Public title
A subjective workload evaluation of augmented reality display of X-ray scattered dose using a glasses-type device
Acronym
A subjective workload evaluation of augmented reality display of X-ray scattered dose using a glasses-type device
Scientific Title
A subjective workload evaluation of augmented reality display of X-ray scattered dose using a glasses-type device
Scientific Title:Acronym
A subjective workload evaluation of augmented reality display of X-ray scattered dose using a glasses-type device
Region
| Japan | Europe |
Condition
Condition
Radiologic technologist, University student
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to evaluate the subjective workload index with or without the augmented reality devices used to visualize X-ray scatter radiation in the CT suite.
Basic objectives2
Others
Basic objectives -Others
Exploratory research of WWL.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
WWL.
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
Positioning for a phantom using a glasses-type augmented reality visualization device and a radiation protection glasses.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Radiologic technologist or student enrolled in the department of radiological sciences, school of health sciences at Narita, International University of Health and Welfare.
3)The person capable of obtaining written consent from the individual for research participation based on free will.
Key exclusion criteria
1)A person who have previously experienced physical discomfort from using glasses-type devices that use virtual reality or augmented reality.
2)A person feeling under the weather, lacking sleep, or experiencing significant fatigue.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Hasegawa |
Organization
International University of Health and Welfare
Division name
School of Health Sciences at Narita, Department of Radiological Sciences
Zip code
286-8686
Address
4-3, Kozunomori, Narita-shi,Chiba-ken
TEL
0476-20-7701
hasegawah-rad@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Hasegawa |
Organization
International University of Health and Welfare
Division name
School of Health Sciences at Narita, Department of Radiological Sciences
Zip code
286-8686
Address
4-3, Kozunomori, Narita-shi,Chiba-ken
TEL
0476-20-7701
Homepage URL
hasegawah-rad@iuhw.ac.jp
Sponsor or person
Institute
International University of health and welfare
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of health and welfare
Address
4-3, Kozunomori, Narita-shi,Chiba-ken
Tel
0476-20-7708
rinri_md@iuhw.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
| 2024 | Year | 09 | Month | 13 | 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
| 2024 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 10 | 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
| 2024 | Year | 09 | Month | 07 | Day |
Last modified on
| 2024 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063361
