UMIN-CTR Clinical Trial

Basic information
Public title	The Effectiveness of Training in a Virtual Reality Coaching System for Radiological Technologist
Acronym	The Effectiveness of Training in a Virtual Reality Coaching System for Radiological Technologist
Scientific Title	The Effectiveness of Training in a Virtual Reality Coaching System for Radiological Technologist
Scientific Title:Acronym	The Effectiveness of Training in a Virtual Reality Coaching System for Radiological Technologist
Region	Japan

Condition
Condition	Education
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigate the effectiveness of student education using a Virtual reality coaching system for radiological technologist (VRC).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Student performance was evaluated in radiographic skills by a licensed radiological technologist.
Key secondary outcomes	1.Examining whether there is a relationship between evaluation results and students' GPA (Grade Point Average). 2.Measurement of gaze and cognitive load related to viewpoint movement, pupil change, and heart rate. 3.Evaluation after use by questionnaire. 4.Analysis of the subject's movements.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
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	Device,equipment
Interventions/Control_1	Trained with the VRC. Only one educational session of about one hour was conducted.
Interventions/Control_2	Trained with role-play. Only one educational session of about one hour was conducted.
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	35 years-old >
Gender	Male and Female
Key inclusion criteria	Students belonging to educational institutions for radiological technologist training program who have not learned radiographic techniques.
Key exclusion criteria	Exclude those who have already learned radiographic techniques.
Target sample size	48

Research contact person
Name of lead principal investigator	1st name Kengo Middle name Last name Kato
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
TEL	0476-20-7701
Email	kengo-kato@umin.ac.jp

Public contact
Name of contact person	1st name Kengo Middle name Last name Kato
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
TEL	0476-20-7701
Homepage URL
Email	kengo-kato@umin.ac.jp

Sponsor
Institute	International University of Health and Welfare
Institute
Department

Funding Source
Organization	International University of Health and Welfare
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	Ethics Review Committee, School of Medicine, International University of Health and Welfare
Address	4-3 Kozunomori, Narita-shi, Chiba
Tel	0476-20-7708
Email	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	2022 Year 03 Month 29 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	30
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	Completed
Date of protocol fixation	2021 Year 09 Month 02 Day
Date of IRB	2021 Year 09 Month 28 Day
Anticipated trial start date	2021 Year 10 Month 10 Day
Last follow-up date	2022 Year 03 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 03 Month 29 Day
Last modified on	2022 Year 03 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052166