UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046090 |
|---|---|
| Receipt number | 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 | 2023/05/19 17:38:21 |
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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
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
okawa@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
Leave a Nest Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 15 | 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
| 2023 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052600
