UMIN-CTR Clinical Trial

Basic information
Public title	The Effect of Virtual Reality on Derilium of trauma patients in Intensive Care Unit.
Acronym	The Effect of Virtual Reality on Derilium of trauma patients in Intensive Care Unit.
Scientific Title	The Effect of Virtual Reality on Derilium of trauma patients in Intensive Care Unit.
Scientific Title:Acronym	The Effect of Virtual Reality on Derilium of trauma patients in Intensive Care Unit.
Region	Japan

Condition
Condition	trauma patients
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The effect of virtual reality on Delirium of trauma patients in Intensive Care Unit .
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intensive Care Delirium Screening Checklist score CAM-ICU
Key secondary outcomes	mortality rate ,vital sign , APACHE2 and SOFA pharmacy ,level of consciousness RASS scale , Visual analog scale the balance between sympathetic nerve with parasympathetic nerve , three month after ICU discharge

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	using Virtual Reality twice away for about one week.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	above 20 years old trauma patients in ICU can confirm
Key exclusion criteria	patients can watch patients can hear no face trauma claustrophobia and acrofobia seizure VR sinckness
Target sample size	220

Research contact person
Name of lead principal investigator	1st name Motomu Middle name Last name Shimaoka
Organization	Mie University Graduate School of Medicine
Division name	Dept of Molecular Pathobiology and Cell Adhesion Biology
Zip code	514-8507
Address	2-174 Edobashi Tsu-City
TEL	0592315036
Email	motomushimaoka@gmail.com

Public contact
Name of contact person	1st name Eiji Middle name Last name Kawamoto
Organization	Mie University Graduate School of Medicine
Division name	Emergency and Disaster Medicine
Zip code	514-8507
Address	2-174 Edobashi Tsu-City
TEL	059-232-1111
Homepage URL
Email	a-2kawamoto@clin.medic.mie-u.ac.jp

Sponsor
Institute	Mie University
Institute
Department

Funding Source
Organization	None
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	Mie University hospital
Address	Edobashi Tsu-city
Tel	0592321111
Email	kk-sien@mo.medic.mie-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	2020 Year 11 Month 01 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	Preinitiation
Date of protocol fixation	2020 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date	2020 Year 10 Month 30 Day
Last follow-up date	2024 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	2020 Year 11 Month 01 Day
Last modified on	2020 Year 11 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048230