UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037574 |
|---|---|
| Receipt number | R000042814 |
| Scientific Title | VR study |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2021/02/01 12:41:56 |
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Basic information
Public title
Measuring effect of VR prehabilitation on prevention from post operative delirium
Acronym
VR study
Scientific Title
VR study
Scientific Title:Acronym
VR study
Region
| Japan |
Condition
Condition
delirium
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
measuring effect of VR prehabilitation on prevention from post operative delirium
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
rate of post operative delirium
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
prehabilitation with VR
Interventions/Control_2
no prehabilitation with vr
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients scheduled for urological surgery who meet either of following state
over 75 years old
taking over 13 seconds at timed up & go test
Key exclusion criteria
heavy cardiac disturbance and respiratory disturbance
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kudo |
Organization
Hirosaki University Hospital
Division name
department of anesthesiology
Zip code
036-8563
Address
53,Honcho, Hirosaki, Aomori
TEL
0172335111
takf5dion@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Kudo |
Organization
Hirosaki University Hospital
Division name
department of anesthesiology
Zip code
036-8563
Address
53, Honcho, Hirosaki, Aomori
TEL
0172335111
Homepage URL
takf5@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hirosaki University Hospital
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
Hirosaki University Graduate School of Medicine Institutional Review Board
Address
5, Zaifucho, Hirosaki, Aomori
Tel
0172395203
rinri@hirosaki-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
| 2019 | Year | 09 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | 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
| 2019 | Year | 08 | Month | 01 | Day |
Last modified on
| 2021 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042814
