UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041157 |
|---|---|
| Receipt number | R000046979 |
| Scientific Title | A quick and safe analgesic intervention for cooling the skin by a peltier device away from the electric power supply |
| Date of disclosure of the study information | 2020/08/01 |
| Last modified on | 2020/07/20 10:50:06 |
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Basic information
Public title
A quick and safe analgesic intervention for cooling the skin by a peltier device away from the electric power supply
Acronym
A quick and safe analgesic intervention for cooling the skin by a peltier device away from the electric power supply
Scientific Title
A quick and safe analgesic intervention for cooling the skin by a peltier device away from the electric power supply
Scientific Title:Acronym
A quick and safe analgesic intervention for cooling the skin by a peltier device away from the electric power supply
Region
| Japan |
Condition
Condition
The needling pain
Classification by specialty
| Medicine in general | Pediatrics | Dermatology |
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Vaccination causes pain for the subject. Using the Peltier device skin cooler apparatus, we examine how the skin cooling by the apparatus alleviates the pain at the skin needling.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analgesic effect
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Skin cooling by a cooled metallic stick
Interventions/Control_2
Skin needling by a 22G needle
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
Healthy adults
Key exclusion criteria
The case under medical treatment
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Seiichi |
| Middle name | |
| Last name | Chba |
Organization
Oita University, Faculty of Medicine
Division name
Anatomy
Zip code
879-5593
Address
1-1, Idaigaoka, Hazama, Yufu, Oita, Japan
TEL
097-549-4411
schiba@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Seiichi |
| Middle name | |
| Last name | Chiba |
Organization
Oita University, Faculty of Medicine
Division name
Anatomy
Zip code
8795593
Address
1-1, Idaigaoka, Hazama, Yufu, Oita, Japan
TEL
0975865623
Homepage URL
schiba@oita-u.ac.jp
Sponsor or person
Institute
Oita University
Institute
Department
Personal name
Funding Source
Organization
Oita University
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
Oita University, Faculty of Medicine
Address
1-1, Idaigaoka, Hazama, Yufu, Oita, Japan
Tel
0975494411
rintiss@oita-u.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
大分大学医学部解剖学講座
Other administrative information
Date of disclosure of the study information
| 2020 | 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
21
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 20 | Day |
Last modified on
| 2020 | 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=R000046979
| 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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| Registered date | File name |
