UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003930 |
|---|---|
| Receipt number | R000004724 |
| Scientific Title | Examination of marker that can evaluate stress response induced by pain objectively - evaluation by quantitative analysis device of esthesia and pain, salivary alpha-amylase, serum malondialdehyde- |
| Date of disclosure of the study information | 2010/07/20 |
| Last modified on | 2010/07/20 20:33:13 |
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Basic information
Public title
Examination of marker that can evaluate stress response induced by pain objectively
- evaluation by quantitative analysis device of esthesia and pain, salivary alpha-amylase, serum malondialdehyde-
Acronym
objective evaluation of stress induced by pain
Scientific Title
Examination of marker that can evaluate stress response induced by pain objectively
- evaluation by quantitative analysis device of esthesia and pain, salivary alpha-amylase, serum malondialdehyde-
Scientific Title:Acronym
objective evaluation of stress induced by pain
Region
| Japan |
Condition
Condition
pain
Classification by specialty
| Anesthesiology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we examine whether salivary alpha-amylase and serum malondialdehyde can be used as effective and objective marker induced by pain stimulus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
analysis of correlation between pain degree and salivary alpha-amylase or serum malondialdehyde
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Collecting blood and saliva sampling:four times for each
Period:two years after approving the ethics committee
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy student and trainee doctor
Key exclusion criteria
Minor
adult person who doesn't have enough judgment
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun kurihara |
Organization
tohoku university graduate school of dentistry
Division name
dento-oral anesthesiology
Zip code
Address
Miyagi Prefecture Sendai City Aoba ward Seiryo-cho 4-1
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
tohoku university graduate school of dentistry
Division name
dento-oral anesthesiology
Zip code
Address
TEL
022-717-8420
Homepage URL
Sponsor or person
Institute
tohoku university graduate school of dentistry dento-oral anesthesiology
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 07 | Month | 20 | 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
| 2010 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | 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
| 2010 | Year | 07 | Month | 20 | Day |
Last modified on
| 2010 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004724
