UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028598 |
|---|---|
| Receipt number | R000032733 |
| Scientific Title | Japanese validation study of the Multidimensional Pain Readiness to Change Questionnaire 2 and its two short-forms |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2021/08/16 15:26:59 |
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Basic information
Public title
Japanese validation study of the Multidimensional Pain Readiness to Change Questionnaire 2 and its two short-forms
Acronym
MPRCQ2-J
Scientific Title
Japanese validation study of the Multidimensional Pain Readiness to Change Questionnaire 2 and its two short-forms
Scientific Title:Acronym
MPRCQ2-J
Region
| Japan |
Condition
Condition
Chronic Pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study aims to develop the Japanese version of the Multidimensional Pain Readiness to Change Questionnaire 2 (MPRCQ2-J) and its
two short-forms, and to evaluate their reliability and validity.
Basic objectives2
Others
Basic objectives -Others
Confirmation of the psychometric properties of the Japanese version of the Multidimensional Pain Readiness to Change Questionnaire 2 (MPRCQ2) and its two short-forms
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
the Japanese version of the Multidimensional Pain Readiness to Change Questionnaire 2 (MPRCQ2-J) and its two short-forms
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1. history of pain over 3 months and more
2. age 20 years and older
3. adequate ability to read and write Japanese
4. willingness to participate in the present study shown by an authentic signature.
Key exclusion criteria
cognitive impairment disturbing responses to the questionnaires
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sei Fukui |
Organization
Shiga University of Medical Science
Division name
Pain Management Clinic, Shiga University of Medical Science Hospital
Zip code
Address
ZIP: 520-2192, Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL
077-548-2281
sei@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomonori Adachi |
Organization
Shiga University of Medical Science
Division name
Pain Management Clinic, Shiga University of Medical Science Hospital
Zip code
Address
ZIP: 520-2192, Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL
077-548-2281
Homepage URL
atom8567@belle.shiga-med.ac.jp
Sponsor or person
Institute
Pain Management Clinic, Shiga University of Medical Science Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
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
| 2017 | 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
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Design: Cross-sectional
Method of Recruitment: Patients who satisfy selection criteria, and attend facilities conducting the present study from August, 2017 to March, 2020
Study Measure:
1. Participant's historical information
2. MPRCQ2-J
3. Cognitive interview guide for MPRCQ2-J
4. Pain Stage of Change Questionnaire
5. Numerical Rating Scale
6. Pain Disability Assessment Scale
7. Pain Self-Efficacy Questionnaire
8. Pain Anxiety Symptom Scale-20
9. the patient's global impression of change
Management information
Registered date
| 2017 | Year | 08 | Month | 09 | Day |
Last modified on
| 2021 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032733
