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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046090
Receipt No. R000052600
Scientific Title Safety of Virtual Reality(VR) experiences in patients after hematopoietic stem cell transplantation in clean room or semi-clean room
Date of disclosure of the study information 2022/01/20
Last modified on 2021/11/16

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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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