UMIN-CTR Clinical Trial

Basic information
Public title	Safety of Virtual Reality(VR) experiences in patients after hematopoietic stem cell transplantation in clean room or semi-clean room
Acronym	Safety of Virtual Reality(VR) experiences in patients after hematopoietic stem cell transplantation in clean room or semi-clean room
Scientific Title	Safety of Virtual Reality(VR) experiences in patients after hematopoietic stem cell transplantation in clean room or semi-clean room
Scientific Title:Acronym	Safety of Virtual Reality(VR) experiences in patients after hematopoietic stem cell transplantation in clean room or semi-clean room
Region	Japan

Condition
Condition	Hematopoietic tumor
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the safety of VR experiences in patients after hematopoietic stem cell transplantation in clean room or semi-clean room
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Simulator Sickness Questionnaire (at before, immediately after, 30minutes after the VR experience)
Key secondary outcomes	salivary alpha-amylase activity (at before, immediately after, 30minutes after the VR experience) Edmonton Symptom Assessment System Revised Japanese version (at before, immediately after, 30minutes after the VR experience)

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	Treatment
Type of intervention	Device,equipment Other
Interventions/Control_1	Wearing the Head-Mounted Display and experiencing VR for about 15 minutes
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	Patients after hematopoietic stem cell transplantation in clean room or semi-clean room Experience VR within a week from 3 days after engraftment
Key exclusion criteria	Decreased mental and cognitive function Wounds and skin symptoms on the head Eye symptoms Visual perception disorders other than myopia, hyperopia, astigmatism, etc. Difficulty wearing the Head-Mounted Display and operating the controllers History of epilepsy
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Yoshitada Middle name Last name Sakai
Organization	Kobe University Graduate School of Medicine
Division name	Rehabilitation Medicine
Zip code	650-0017
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo
TEL	078-382-6940
Email	yossie@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Naoko Middle name Last name Okawa
Organization	Kobe University Hospital
Division name	Medical Technology Department
Zip code	650-0017
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo
TEL	075-382-6493
Homepage URL
Email	okawa@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Hospital
Institute
Department

Funding Source
Organization	None
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	Kobe University Hospital, Ethics Review Committee
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo
Tel	078-382-6669
Email	kainyu@med.kobe-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	神戸大学医学部附属病院（兵庫県）/ Kobe University Hospital(Hyogo)

Other administrative information
Date of disclosure of the study information	2022 Year 01 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
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	2021 Year 11 Month 16 Day
Date of IRB
Anticipated trial start date	2022 Year 01 Month 20 Day
Last follow-up date	2024 Year 01 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 11 Month 16 Day
Last modified on	2021 Year 11 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052600

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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