臨床研究等提出・公開システム

Date of registration	Oct. 16, 2024
Last modified on	Oct. 16, 2024
Trial ID	jRCT1040240106

Scientific Title	An Exploratory Study on the Quantification of Pain Stimuli Using a Pain Checker
Public Title	An Exploratory Study on the Quantification of Pain Stimuli Using a Pain Checker

Contact for Scientific Queries	Name	Aiko Naruse
	Affiliation	Hamamatsu University School of Medicine
	Address	1-20-1 Handayama, Chuo-ku, Hamamatsu, Shizuoka, 431-3192, Japan
	Telephone	+81-53-435-2431
	E-mail	anaruse@hama-med.ac.jp
Contact for Public Queries	Name	Aiko Naruse
	Affiliation	Hamamatsu University School of Medicine
	Address	1-20-1 Handayama, Chuo-ku, Hamamatsu, Shizuoka, 431-3192, Japan
	Telephone	+81-534352431
	E-mail	anaruse@hama-med.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Oct. 16, 2024
Target sample size		30
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	factorial assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	1. Adult men and women aged 18 years or older 2. Individuals who have provided consent to participate in this study by signing the consent form
	Exclusion Criteria	1. Individuals with peripheral neuropathy, such as diabetes or carpal tunnel syndrome 2. Individuals with injuries to the non-dominant hand's fingers or nails 3. Individuals who have taken analgesics within six hours prior to participation 4. Individuals undergoing anticoagulant therapy or with a bleeding tendency
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		none
Intervention(s)		Pain stimuli will be applied to the nail beds of all fingers on the non-dominant hand of the participants using a pain checker developed by the researcher.
Primary Outcome(s)		The pressure value (g) per unit area at the moment the participant perceives the pain stimulus on the nail bed as painful.
Secondary Outcome(s)		Height, Weight and BMI

Primary Sponsor	none

Name of Certified Review Board	Clinical Research Review Board, Hamamatsu University School of Medicine
Address	1-20-1 Handayama, Chuo-ku, Hamamatsu, Shizuoka, 431-3192, Japan, Shizuoka
Telephone	+81-53-435-2680
E-Mail	kenkyou.s@hama-med.ac.jp
Approval Status	Approval
Date of approval	Sept. 20, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none