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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name