UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045039 |
|---|---|
| Receipt number | R000051448 |
| Scientific Title | Development of measures to promote home rehabilitation using virtual reality pain relief |
| Date of disclosure of the study information | 2021/08/02 |
| Last modified on | 2024/02/08 11:00:16 |
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Basic information
Public title
Development of measures to promote home rehabilitation using virtual reality pain relief
Acronym
Development of measures to promote home rehabilitation using VR-based pain relief
Scientific Title
Development of measures to promote home rehabilitation using virtual reality pain relief
Scientific Title:Acronym
Development of measures to promote home rehabilitation using VR-based pain relief
Region
| Japan |
Condition
Condition
Chronic Pain
Classification by specialty
| Rehabilitation medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will conduct an intervention study with home rehabilitation using virtual reality (VR) for homebound patients with chronic pain. This study will evaluate the feasibility of the intervention in this study by setting up only a single group of home rehabilitation using VR and no control group for comparison.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Chronic Pain
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Conduct home visit rehabilitation with virtual reality one to two times per week for a total of 10 interventions; each intervention should last 10 to 20 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
They have chronic pain
They are using home-visit rehabilitation services under long-term care insurance or medical insurance
The patient has sufficient sensory function to use the VR equipment
The patient has sufficient cognitive function to measure subjective symptoms such as pain
Age 20 years or older
The patient's free written consent to participate in this study has been obtained after adequate informed consent
Key exclusion criteria
Patients who have a history of adverse events due to the use of the VR equipment
Patients who are judged by the principal investigator or sub-investigator to be inappropriate as research subjects
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Funao |
Organization
Mie University Graduate School of Medicine
Division name
Course of Nursing Science, Adult Health Nursing
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie, JAPAN, 514-8507
TEL
059-231-5260
h-funao@med.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Funao |
Organization
Mie University Graduate School of Medicine
Division name
Mie University Graduate School of Medicine
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie, JAPAN, 514-8507
TEL
059-231-5260
Homepage URL
h-funao@med.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
Funding Source
Organization
Mie University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mie University
Address
2-174 Edobashi, Tsu, Mie, JAPAN, 514-8507
Tel
059-231-5260
h-funao@med.mie-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
| 2021 | Year | 08 | Month | 02 | 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 | 08 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2029 | 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
| 2021 | Year | 08 | Month | 02 | Day |
Last modified on
| 2024 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051448
