UMIN-CTR Clinical Trial

Basic information
Public title	a study on the educational effectiveness of online practice in occupational therapy using virtual reality
Acronym	the educational effectiveness of online practice in occupational therapy using virtual reality
Scientific Title	a study on the educational effectiveness of online practice in occupational therapy using virtual reality
Scientific Title:Acronym	the educational effectiveness of online practice in occupational therapy using virtual reality
Region	Japan

Condition
Condition	university students
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to clarify the effects of online occupational therapy practice in real-time using VR on the stigma toward people with dementia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Attitudes toward People with Dementia (Dementia Attitude Scale) Measurements are taken at two time points: the day before the start of the training and within 30 minutes immediately after the end of the training.
Key secondary outcomes	Image of the Elderly and People with Dementia Knowledge of people with dementia (Dementia Knowledge Scale) Satisfaction with practical training Attitudes toward People with Dementia (Dementia Attitude Scale) Measurements are taken at two time points: the day before the start of the training and within 30 minutes immediately after the end of the training.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
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	intervention/controll For the intervention group, the following occupational therapy scenes in a geriatric health care facility will be conducted: (1) 40 minutes of real-time viewing of occupational therapy scenes through VR, and (2) 20 minutes of Q&A session by the occupational therapist in charge of the patients.
Interventions/Control_2	For the control group, the same thing is viewed two-dimensionally on a PC screen.
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	20 years-old <=
Age-upper limit	25 years-old >
Gender	Male and Female
Key inclusion criteria	Those who have obtained the consent of 26 third-year students of the Occupational Therapy major.
Key exclusion criteria	Those who did not agree to the invitation to 26 third-year students of the Occupational Therapy major.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Tanaka Middle name Last name Hiroyuki
Organization	Osaka Metropolitan University
Division name	graduate school of rehabilitation
Zip code	583-8555
Address	Habikino, Habikino City, Osaka, Japana
TEL	072-950-2111
Email	hytanaka@omu.ac.jp

Public contact
Name of contact person	1st name Tanaka Middle name Last name Hiroyuki
Organization	Osaka Metropolitan University
Division name	graduate school of rehabilitation
Zip code	583-8555
Address	Habikino, Habikino City, Osaka, Japana
TEL	072-950-2111
Homepage URL
Email	hytanaka@omu.ac.jp

Sponsor
Institute	Osaka Metropolitan University
Institute
Department

Funding Source
Organization	Osaka Metropolitan Univerisity
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka Metropolitan University graduate school of rehabilitation, IRB
Address	Habikino, Habikinocity, Osaka Japan
Tel	072-950-2111
Email	gr-hab-shinsa@omu.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 09 Month 20 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	19
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	2022 Year 07 Month 01 Day
Date of IRB	2022 Year 07 Month 26 Day
Anticipated trial start date	2022 Year 09 Month 01 Day
Last follow-up date	2022 Year 10 Month 01 Day
Date of closure to data entry	2022 Year 11 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 09 Month 17 Day
Last modified on	2022 Year 11 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055774