UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033126 |
|---|---|
| Receipt number | R000037778 |
| Scientific Title | Relaxation and relief of chronic pain by Virtual Reality application |
| Date of disclosure of the study information | 2018/06/30 |
| Last modified on | 2019/06/25 13:21:23 |
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Basic information
Public title
Relaxation and relief of chronic pain by Virtual Reality application
Acronym
Relaxation and relief of chronic pain by Virtual Reality application
Scientific Title
Relaxation and relief of chronic pain by Virtual Reality application
Scientific Title:Acronym
Relaxation and relief of chronic pain by Virtual Reality application
Region
| Japan |
Condition
Condition
Chronic pain
Classification by specialty
| Surgery in general | Urology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Measuring the effect of3D VR intervention on chronic pain in patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Virtual Reality
Interventions/Control_2
2D monitor television
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1, Chronic pain score 3/10 or more
2, Between 20 and 65 years old
3, After receiving sufficient explanation for participation in this research, document agreement is obtained with the free will of the subject himself with sufficient understanding
4, ECOG performance status 0-1
Key exclusion criteria
1, Patients under 20 years old
2, Patients who do not agreed
3, Patients with underlying diseases such as nausea, vomiting, dementia, agitation, seizures, seizures, epilepsy
4, Patients have some visual impairment
5, If the research director and the research sharing person judge that they are inappropriate for research, they will not be subject patients
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeo Horie |
Organization
Juntendo University, Graduate School of Medicine
Division name
Department of Urology
Zip code
Address
Hongo 2-1-1, Bunkyo, Tokyo
TEL
03-5802-1227
shorie@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuji Isotani |
Organization
Juntendo University, Graduate School of Medicine
Division name
Department of Urology
Zip code
Address
Hongo 2-1-1, Bunkyo, Tokyo
TEL
03-5802-1227
Homepage URL
shujiisotani@gmail.com
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University, Graduate School of Medicine
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
Address
Tel
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
| 2018 | Year | 06 | Month | 30 | 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
| 2018 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2023 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2024 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 24 | Day |
Last modified on
| 2019 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037778
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
