UMIN-CTR Clinical Trial

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