UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062871 |
|---|---|
| Receipt number | R000071970 |
| Scientific Title | Establishment of an Experimental Method Using Similarity Ratings of Thermal Sensation and Thermal Comfort and Identification of Thermal Qualia Structure |
| Date of disclosure of the study information | 2026/09/10 |
| Last modified on | 2026/09/10 13:36:06 |
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Basic information
Public title
Establishment of an Experimental Method Using Similarity Ratings of Thermal Sensation and Thermal Comfort and Identification of Thermal Qualia Structure
Acronym
Establishment of an Experimental Method Using Similarity Ratings of Thermal Sensation and Thermal Comfort and Identification of Thermal Qualia Structure
Scientific Title
Establishment of an Experimental Method Using Similarity Ratings of Thermal Sensation and Thermal Comfort and Identification of Thermal Qualia Structure
Scientific Title:Acronym
Establishment of an Experimental Method Using Similarity Ratings of Thermal Sensation and Thermal Comfort and Identification of Thermal Qualia Structure
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop an experimental method for estimating and visualizing the relational structures of thermal sensation and thermal comfort based on perceived-dissimilarity ratings between pairs of thermal stimuli. The study will also examine the test-retest reproducibility of the method and the influence of stimulus presentation order.
Basic objectives2
Others
Basic objectives -Others
Development of a method for estimating and visualizing the relational structures of thermal sensation and thermal comfort, and assessment of its reproducibility.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Dissimilarity ratings for thermal sensation and thermal comfort between each pair of thermal stimuli, assessed immediately after each pair presentation on an 8-point scale from 0 (completely the same) to 7 (completely different). Dissimilarity matrices and multidimensional scaling (MDS) configurations will be derived separately for thermal sensation and thermal comfort for each experimental session.
Key secondary outcomes
1. Test-retest reproducibility of the dissimilarity matrices and MDS configurations between the first session and a repeat session conducted at least 3 days later.
2. Differences in the dissimilarity matrices and MDS configurations among the three stimulus-presentation order conditions.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Thermal sensory thresholds will first be measured. Paired thermal stimuli consisting of nine temperatures from 10 to 50 degrees Celsius in 5-degree increments will then be simultaneously applied to the bilateral forearms for 1 second. In each session, a total of 89 paired presentations will be administered: all 81 combinations plus 8 repeated pairs. Immediately after each presentation, participants will rate how different the two stimuli feel in terms of thermal sensation and thermal comfort on an 8-point scale from 0 (completely the same) to 7 (completely different). A 10-second interval will be provided before the next stimulus presentation. Four sessions will be conducted at intervals of at least 3 days: an initial session, one retest using the same stimulus conditions and presentation order, and two sessions using different presentation orders.
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
| 18 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy undergraduate or graduate students enrolled at Niigata University of Health and Welfare, aged 18 to 35 years.
2. Individuals who have received and understood a sufficient explanation of the purpose and procedures of the study and have voluntarily provided written informed consent.
3. Individuals who are able to participate in all four measurement sessions conducted on separate days.
Key exclusion criteria
1. Individuals with a history or current diagnosis of a skin or neurological disorder.
2. Individuals with chronic pain or sensory abnormalities.
3. Individuals who regularly use medication.
4. Individuals with a history of smoking.
5. Individuals with fever, alcohol consumption, medication use, or any other health condition on the day of measurement that may interfere with study participation.
6. Individuals otherwise judged by the principal investigator to be unsuitable for participation.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | shintani |
| Middle name | |
| Last name | koki |
Organization
Niigata University of Health and Welfare
Division name
Field of Health and Sports, Major in Health Sciences, Graduate School of Health and Welfare
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata 950-3198, Japan
TEL
0252574455
wtm26001@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | shintani |
| Middle name | |
| Last name | koki |
Organization
Niigata University of Health and Welfare
Division name
Field of Health and Sports, Major in Health Sciences, Graduate School of Health and Welfare
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata 950-3198, Japan
TEL
0252574455
Homepage URL
wtm26001@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
koki shintani
Funding Source
Organization
Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata 950-3198, Japan
Tel
0252574455
rinri@nuhw.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2031 | 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
| 2026 | Year | 09 | Month | 10 | Day |
Last modified on
| 2026 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071970
