UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014614 |
|---|---|
| Receipt number | R000015412 |
| Scientific Title | Objective evaluation of pain |
| Date of disclosure of the study information | 2014/08/01 |
| Last modified on | 2021/01/15 10:47:05 |
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Basic information
Public title
Objective evaluation of pain
Acronym
Objective evaluation of pain
Scientific Title
Objective evaluation of pain
Scientific Title:Acronym
Objective evaluation of pain
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We are going to seek the objective way for evaluating pain
Basic objectives2
Others
Basic objectives -Others
We are going to measure various vital signs including ECG and skin conductance during painful and non-painful stimulus for seeking the objective way for evaluating pain.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1. We are going to investigate the relationship between numerical rating scale and vital signs including skin conductance, heart rate variability, and arterial oxygen saturation during heat stimulation.
2. We are going to compare the changes in skin conductance after 5 different stimuli.
Key secondary outcomes
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
Prevention
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
The device for heat and mechanical stimulation, skin conductance monitor,audiometer
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults between 20 and 60 years old with informed consent
Key exclusion criteria
Subject with chronic pain
Subject who can not understand the protocol
Subject who can not tolerate heat stimulus
Subject who has a medication acting on autonomic nerve system
Subject who is not suitable for giving heat stimulus due to severe disease
Pregnant woman
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Satomi |
| Middle name | |
| Last name | Sugimine |
Organization
Gunma University Hospital
Division name
Department of Anesthesiology
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi, Gunma 371-8511, Japan
TEL
027-220-8454
s-satomi@umin.ac.jp
Public contact
Name of contact person
| 1st name | Satomi |
| Middle name | |
| Last name | Sugimine |
Organization
Gunma University Hospital
Division name
Department of Anesthesiology
Zip code
3718511
Address
3-39-15 Showa-machi, Maebashi, Gunma 371-8511, Japan
TEL
027-220-8454
Homepage URL
s-satomi@umin.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Gunma University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Hospital
Address
3-39-15, showa-machi, maebashi-shi, Gunma-ken
Tel
027-220-7111
gunmaciru-office@umin.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
群馬大学医学部附属病院(群馬県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 01 | 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
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 24 | Day |
Date of IRB
| 2013 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 22 | Day |
Last modified on
| 2021 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015412
