UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053227 |
|---|---|
| Receipt number | R000060746 |
| Scientific Title | Effect of skin temperature at the start of immersion on the cutaneous vasodilation to immersion in carbonated water |
| Date of disclosure of the study information | 2023/12/26 |
| Last modified on | 2023/12/26 15:33:17 |
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Basic information
Public title
Effect of skin temperature at the start of immersion on the cutaneous vasodilation to immersion in carbonated water
Acronym
Effect of skin temperature at the start of immersion on the cutaneous vasodilation to immersion in carbonated water
Scientific Title
Effect of skin temperature at the start of immersion on the cutaneous vasodilation to immersion in carbonated water
Scientific Title:Acronym
Effect of skin temperature at the start of immersion on the cutaneous vasodilation to immersion in carbonated water
Region
| Japan |
Condition
Condition
heat stroke
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Heat stroke may occur when body temperature rises excessively. To prevent heat stroke or recover from heat stroke, the elevated body temperature must be quickly lowered. One method of lowering elevated body temperature is cold water immersion. Carbonated water is more effective than tap water in lowering body temperature quickly because it promotes heat transfer through dilation and expansion of skin blood vessels. This study will serve as a basic research to establish a cooling method using carbonated water.
Basic objectives2
Others
Basic objectives -Others
Based on previous study, it is possible that the skin vasodilation effect of carbonated water immersion differs depending on the difference in skin temperature at the start of immersion (i.e., the degree of dilation of skin blood vessels). Therefore, this study examines the effects of differences in skin temperature at the start of immersion in a low-temperature carbonated water on skin blood flow during immersion.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
skin blood flow during immersion in carbonated water
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
After immersing the left forearm in tap water set at 40 degrees C for 5 minutes to increase skin temperature and dilate skin blood vessels, the left forearm is immersed in a carbonated water set at 25 degrees C for 15 minutes.
Interventions/Control_2
After immersing the left forearm in tap water set at 32 degrees C for 5 minutes to increase skin temperature and dilate skin blood vessels, the left forearm is immersed in a carbonated water set at 25 degrees C for 15 minutes.
Interventions/Control_3
After immersing the left forearm in tap water set at 25 degrees C for 5 minutes to increase skin temperature and dilate skin blood vessels, the left forearm is immersed in a carbonated water set at 25 degrees C for 15 minutes.
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
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
healthy male
Key exclusion criteria
Persons with abnormal findings in medical examinations
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Keiji |
| Middle name | |
| Last name | Hayashi |
Organization
University of Shizuoka
Division name
Junior college
Zip code
422-8021
Address
2-2-1 Oshika, Suruga-ku, Shizuoka
TEL
054-202-2639
khayashi@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | Keiji |
| Middle name | |
| Last name | Hayashi |
Organization
Univerisity of Shizuoka
Division name
Junior College
Zip code
422-8021
Address
2-2-1 Oshika, Suruga-ku, Shizuoka
TEL
054-202-2639
Homepage URL
khayashi@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka, Junior College
Institute
Department
Personal name
Keiji Hayashi
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Shizuoka
Address
52-1 Yada, Suruga-ku, Shizuoka
Tel
054-264-5103
rinri@u-shizuoka-ken.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
| 2023 | Year | 12 | Month | 26 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 12 | Month | 26 | Day |
Last modified on
| 2023 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060746
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