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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033214
Receipt No. R000037872
Scientific Title Reliability and validity study of the Japanese version of Chronic Pain Acceptance Questionnaire (CPAQ-J)
Date of disclosure of the study information 2018/06/30
Last modified on 2020/09/27

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Basic information
Public title Reliability and validity study of the Japanese version of Chronic Pain Acceptance Questionnaire (CPAQ-J)
Acronym Reliability and validity study of the Japanese version of Chronic Pain Acceptance Questionnaire (CPAQ-J)
Scientific Title Reliability and validity study of the Japanese version of Chronic Pain Acceptance Questionnaire (CPAQ-J)
Scientific Title:Acronym Reliability and validity study of the Japanese version of Chronic Pain Acceptance Questionnaire (CPAQ-J)
Region
Japan

Condition
Condition chronic pain
Classification by specialty
Psychosomatic Internal Medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Development of the Japanese version of the Chronic Pain Acceptance Questionnaire (CPAQ-J), and Validity study of CPAQ-J
Basic objectives2 Others
Basic objectives -Others development of a questionnaire
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cronbach's alpha
test-retest correlation
correlation between the CPAQ-J score and pain-related variables
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1)Patients with non-malignant pain (at least 3 months duration), treated at the department of Psychosomatic medicine, Kyushu University Hospital
2)Paitents who consented to participate in this study
Key exclusion criteria 1)Patients who suffer from severe cognitive problems such as severe mood disorders, psychosis, mental retardation, dementia, high-order brain dysfunction, substance related disorders
2)Patients who can not complete questionnaires by themselves
Target sample size 220

Research contact person
Name of lead principal investigator
1st name Nobuyuki
Middle name
Last name Sudo
Organization Graduate School of Medical Sciences., Kyushu University
Division name Deptartment of Psychosomatic Medicine
Zip code 812-8582
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka City, Japan
TEL 092-642-5318
Email nobuyuki@med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Kozo
Middle name
Last name Anno
Organization Kyushu University Hospital
Division name Deptartment of Psychosomatic Medicine
Zip code 812-8582
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka City, Japan
TEL 092-642-5320
Homepage URL
Email annok@cephal.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University hospital
Institute
Department

Funding Source
Organization Kyushu University hospital
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 Kyushu University Institutional Review Board for Clinical Research
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka City, Japan
Tel 092-642-5774
Email bynintei@jimu.kyushu-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
2018 Year 06 Month 30 Day

Related information
URL releasing protocol http://www.cephal.med.kyushu-u.ac.jp/
Publication of results Unpublished

Result
URL related to results and publications http://www.cephal.med.kyushu-u.ac.jp/
Number of participants that the trial has enrolled 216
Results
chronic pain acceptance questionnaire-J
mean score 47.4 (SD 16.7)

<reliability>
Cronbach's alpha = 0.82
test-retest reliability r = 0.94

<correlation analysis>
pain intensity (BPI) -0.27 (P<0.01)
disability (PDAS) -0.38 (P<0.01)
depression (HADS-D) -0.40 (P<0.01)
anxiety (HADS-A) -0.51 (P<0.01)
pain catastrophizing (PCS) -0.63 (P<0.0)
life satisfaction (VAS) 0.48 (P<0.01)
Results date posted
2020 Year 09 Month 27 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
mean age (years) 48.4 (SD 16.0)
female 78,7%
median pain duration (months) 35 (IQ 12-99)
Participant flow
complete
Adverse events
non
Outcome measures
<questionnaires>
Chronic pain acceptance questionnaire
Brief pain inventory
Pain disability assessment scale
pain catastrophizing scale
Hospital anxiety and depression scale
life satisfaction (visual analogue scale)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 08 Month 29 Day
Date of IRB
2014 Year 08 Month 26 Day
Anticipated trial start date
2014 Year 08 Month 29 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 none

Management information
Registered date
2018 Year 06 Month 30 Day
Last modified on
2020 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037872

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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