UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013228 |
|---|---|
| Receipt number | R000015438 |
| Scientific Title | Pain strength and saliva alpha amylase of the pain patient, other pain-related relations with the factor |
| Date of disclosure of the study information | 2014/02/24 |
| Last modified on | 2014/02/23 11:57:15 |
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Basic information
Public title
Pain strength and saliva alpha amylase of the pain patient, other pain-related relations with the factor
Acronym
Pain strength and saliva alpha amylase of the pain patient, other pain-related relations with the factor
Scientific Title
Pain strength and saliva alpha amylase of the pain patient, other pain-related relations with the factor
Scientific Title:Acronym
Pain strength and saliva alpha amylase of the pain patient, other pain-related relations with the factor
Region
| Japan |
Condition
Condition
Patients having a pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose investigate a pain and relations of alpha amylase for patients having a pain.
Basic objectives2
Others
Basic objectives -Others
As well as a pain, We check a state of the stress checked by question vote Stress Response Scale-18(SRS-18), state of feeling such as strain, dejection, anger, vigor, fatigue(Profile of mode state: POMS), the pain Catastrophizing Scale(PCS) and the quality of life (EuroQual-5Demention).
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Visual Analogue Scale
Saliva alpha amylase
Key secondary outcomes
Stress Response Scale-18(SRS-18)
simplified Profile of mode state(simplified POMS)
Pain Catastrophizing Scale(PCS)
EuroQuol-5Dimention Questionnaire(EQ5-D)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
We measure saliva alpha amylase by one point
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
| 15 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients having a pain
Key exclusion criteria
patients who cannot fill out a question vote
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Rie Hasegawa |
Organization
Juntendo University School of Medicine
Division name
Department of Anesthesiology and Pain Medicine
Zip code
Address
3-1-3 hongou bunkyou-ku Tokyou 113-8431 Japan
TEL
090-8350-5708
rhase@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rie Hasegawa |
Organization
Juntendo University School of Medicine
Division name
Department of Anesthesiology and Pain Medicine
Zip code
Address
3-1-3 hongou bunkyou-ku Tokyou 113-8431 Japan
TEL
090-8350-5708
Homepage URL
rhase@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine, Department of Anesthesiology and Pain Medicine
Institute
Department
Personal name
Funding Source
Organization
Juntendo University School of Medicine, Department of Anesthesiology and Pain Medicine
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
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
| 2014 | Year | 02 | Month | 24 | 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
| 2014 | Year | 02 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 24 | 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
| 2014 | Year | 02 | Month | 23 | Day |
Last modified on
| 2014 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015438
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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