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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033126
Receipt No. 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

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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
Email 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
Email shujiisotani@gmail.com

Sponsor
Institute Juntendo University
Institute
Department

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
Email

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
URL(English) https://upload.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


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