Tokyo, Sept. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062871) titled 'Establishment of an Experimental Method Using Similarity Ratings of Thermal Sensation and Thermal Comfort and Identification of Thermal Qualia Structure' on Sept. 10.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - Niigata University of Health and Welfare
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
Eligibility:
Age-lower limit - 18
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 Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 01 Day
Anticipated trial start date - 2026 Year 10 Month 01 Day
Last follow-up date - 2031 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071970
Disclaimer: Curated by HT Syndication.