Tokyo, Dec. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059661) titled 'Evaluation of the effectiveness of hot and cold stimulation on cognitive task load' on Dec. 31.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Kao Corporation
Condition:
Condition - Not applicable
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine the effectiveness of hot and cold stimulation on cognitive task load, and to explore physiological changes caused by cognitive task load.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Apply sheet formulation for approximately 65 minutes during the cognitive task and until the end of the study. -> washout period -> cognitive task only
Interventions/Control_2 - cognitive task only -> washout period -> Apply sheet formulation for approximately 65 minutes during the cognitive task and until the end of the study.
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - Person who feels head fatigue at work
Key exclusion criteria - 1. Person who is currently undergoing treatment for a disease
2. Person who is currently taking medication
3. Pregnant or suspected to be pregnant
4. Person with sensitivity to cold
5. person who is uncomfortable with cold stimuli such as menthol stimulation
6. Person who has difficulty or is uncomfortable with the use of compresses
7. Person who does not like the smell of bergamot or mint
8. Person who has strong reactions to tape adhesive or alcohol-impregnated cotton for probe placement
9. Person who has difficulty responding to biological sex
10. Person who is already participating in other research studies at the time of receiving explanations about the research, or person who plans to participate in other research studies during the period of cooperation for participation in this study.
11. person who is deemed by the principal investigator to be unsuitable to participate in the research due to non-compliance or other reasons.
Target Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 15 Day
Date of IRB - 2025 Year 10 Month 15 Day
Anticipated trial start date - 2025 Year 10 Month 29 Day
Last follow-up date - 2025 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068245
Disclaimer: Curated by HT Syndication.