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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034006
Receipt No. R000038773
Scientific Title Psychosomatic study on subjective assessment of physical activity in chronic pain patients
Date of disclosure of the study information 2018/09/04
Last modified on 2018/09/03

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Basic information
Public title Psychosomatic study on subjective assessment of physical activity in chronic pain patients
Acronym Psychosomatic study on subjective assessment of physical activity in chronic pain patients
Scientific Title Psychosomatic study on subjective assessment of physical activity in chronic pain patients
Scientific Title:Acronym Psychosomatic study on subjective assessment of physical activity in chronic pain patients
Region
Japan

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

Objectives
Narrative objectives1 We clarified the degree of difference between physical activity by objective measuring instruments and physical activity by subjective scale and the relationship between psychological characteristics and introceptive awareness in chronic pain patients, We will consider the support of effective physical activity for future chronic pain patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes physical activity
Accelerometer(ActiGraph GT3X-BT ActiGraph LLC, Pensacola, FL, USA)
Questionnaire(The International Physical Activity Questionnaire Short Form)
Key secondary outcomes psychological assessment
heartbeat tracking task

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 Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 1 Basic information of research subject: Gender, age, disease, illness period, BMI, education history, preference, medication situation, surgical history, marital status

2 Cognitive function test: MMSE (Mini Mental State Examination)

3 Heartbeat tracking task

4 Objective physical activity measurement: Accelerometer(ActiGraph GT3X-BT ActiGraph LLC, Pensacola, FL, USA)

5 Psychological assessment :Short-Form McGill Pain Questionnaire(SF-MPQ), Pain Self Efficacy Questionnaire(PSEQ), Hospital Anxiety and Depression Scale(HADS), Pain Catastrophizing Scale(PCS), Toront Alexithymia Scale 20(TAS-20), Chronic Pain Acceptance Questionnaire(CPAQ), The Somatosensory Amplification Scale(SSAS), SF-8, Sense of Coherence scale(SOC)

6 Subjective Physical Activity Scale:The International Physical Activity Questionnaire Short Form(IPAQ-SF)
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 Persons whose age is 20 years or older at the time of acquiring consent
2 After receiving sufficient explanation for participation in this research, those who gained consent from the research subjects' free will with sufficient understanding
Key exclusion criteria 1 Persons who has a decline in cognitive function
2 Persons with arrhythmia
3 Those whose mental illness is the main disease name
4 Persons who lack ability to express intention
5 Other,those who have judged that the research director is inappropriate as the research subject
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisaharu Shizuma
Organization Kansai Medical University Graduate School
Division name department of psychosomatic medicine
Zip code
Address 2-5-1 Shin-machi, Hirakata City, Osaka 573-0101 Japan
TEL 072-804-0101
Email shizumah@hirakata.kmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hisaharu Shizuma
Organization Kansai Medical University Graduate School
Division name department of psychosomatic medicine
Zip code
Address 2-5-1 Shin-machi, Hirakata City, Osaka 573-0101 Japan
TEL 072-804-0101
Homepage URL
Email shizumah@hirakata.kmu.ac.jp

Sponsor
Institute Department of psychosomatic medicine, Kansai Medical University Graduate School
Institute
Department

Funding Source
Organization Department of psychosomatic medicine, Kansai Medical University Graduate School
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Hankai Hospital
Kyoto College of Medical Health
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
2018 Year 09 Month 04 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 Preinitiation
Date of protocol fixation
2018 Year 04 Month 16 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 03 Day
Last modified on
2018 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038773

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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