UMIN-CTR Clinical Trial

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
Email	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
Email	s-satomi@umin.ac.jp

Sponsor
Institute	Department of Anesthesiology, Gunma University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015412