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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041157
Receipt No. 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

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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
Email 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
Email schiba@oita-u.ac.jp

Sponsor
Institute Oita University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046979

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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