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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000009261
Receipt No. R000010873
Scientific Title The effect of the emotion for body to pain.
Date of disclosure of the study information 2012/11/06
Last modified on 2012/11/05

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Basic information
Public title The effect of the emotion for body to pain.
Acronym The effect of emotion for body to pain, and research of the brain activity.
Scientific Title The effect of the emotion for body to pain.
Scientific Title:Acronym The effect of emotion for body to pain, and research of the brain activity.
Region
Japan

Condition
Condition healthy subject
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To reveal the effect of the body affect to pain.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes Pain threshold
electroencephalographic data
psychological estimation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 The group of evoked unpleasant emotion for body.
Interventions/Control_2 The group of not evoked unpleasant emotion for body.
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
30 years-old >=
Gender Male and Female
Key inclusion criteria not injured healthy subjects
Key exclusion criteria orthopedic disorder
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Michihiro Osumi
Organization Kio University
Division name Graduate School of Health Science
Zip code
Address 4-2-2Umami-naka, Koryo-tyo, Kitakatsuragi-gun, Nara
TEL 0745-54-1600
Email

Public contact
1st name of contact person
1st name
Middle name
Last name
Organization Kio University
Division name Graduate School of Health Science
Zip code
Address
TEL
Homepage URL
Email p0511109@univ.kio.ac.jp

Sponsor
Institute Kio university Graduate School of Health Science
Institute
Department

Funding Source
Organization Kio university Graduate School of Health Science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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
2012 Year 11 Month 06 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
2012 Year 11 Month 06 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 13 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
2012 Year 11 Month 05 Day
Last modified on
2012 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010873

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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