UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038421 |
|---|---|
| Receipt number | R000043783 |
| Scientific Title | Development of support function to promote behavioral change for rehabilitation |
| Date of disclosure of the study information | 2019/12/24 |
| Last modified on | 2021/03/18 13:03:48 |
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Basic information
Public title
Development of support function to promote behavioral change for rehabilitation
Acronym
Development of support function to promote behavioral change for rehabilitation
Scientific Title
Development of support function to promote behavioral change for rehabilitation
Scientific Title:Acronym
Development of support function to promote behavioral change for rehabilitation
Region
| Japan |
Condition
Condition
Chronic pain
Classification by specialty
| Anesthesiology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the effectiveness of the feedback message system which is implemented to promote behavioral change for Virtual Reality based Mirror Visual Feedback
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Task execution count, the questionnaire on psychological reactance,the Pain Catastrophizing Scale to measure the degree of catastrophic thinking, and the Pain Anxiety Symptoms Scale to measure fear of pain.
Only the number of task executions count is extracted from the system log. Otherwise, after each experiment, measure by questionnaire.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Gives a feedback message that presents a high risk after the first task. After that, ask them to do the second task.
Interventions/Control_2
Gives a feedback message that presents a low risk after the first task. After that, ask them to do the second task.
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
(1)Patients are required to meet the following conditions:
1. consenting to voluntary participation of the study with consent form
2. suffering from refractory chronic pain, such as neuropathic pain
3. receiving medical care in one or more of the following department of Okayama University Hospital:
3.1. Anesthesiology and Resuscitology Department
3.2. Neuropsychiatry Department
(2)Healthy people are required to meet the following conditions:
1. consenting to voluntary participation of the study with consent form
2. having a mid-level educational experience, more than the average high school graduate
3. over 20 year old
Key exclusion criteria
Patients who are unable to operate information input devices from some reasons, such as severe pain or motor disturbance, are excluded.
There is no key exclusion criteria for healthy person.
Target sample size
58
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Gofuku |
Organization
Okayama University
Division name
Graduate School of Interdisciplinary Science and Engineering in Health Systems
Zip code
7008530
Address
#408 Studies of Natural Science and Technology,3-1-1,Tsushimanaka,Kita-ku,Okayama-shi, Okayama,700-0082,Japan
TEL
086-251-8022
fukuchan@sys.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Akio |
| Middle name | |
| Last name | Gofuku |
Organization
Okayama University
Division name
Graduate School of Interdisciplinary Science and Engineering in Health Systems
Zip code
7008530
Address
#408 Studies of Natural Science and Technology,3-1-1,Tsushimanaka,kita-ku,Okayama-City, Okayama Pref
TEL
086-251-8022
Homepage URL
fukuchan@sys.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Ministry of education and Science
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
Okayama University
Address
#408 Studies of Natural Science and Technology,3-1-1,Tsushimanaka,kita-ku,Okayama-City, Okayama Prefecture, 700-0082,Japan
Tel
086-251-8022
fukuchan@sys.okayama-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 | 12 | Month | 24 | 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
96
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
Completed
Date of protocol fixation
| 2019 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 24 | Day |
Last follow-up date
| 2022 | 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 | 10 | Month | 29 | Day |
Last modified on
| 2021 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043783
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/03/18 | 実施計画書_nita_201023_修正.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2021/03/18 | 質問紙_ver0114.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2021/03/18 | 20実験分析.xlsx |
