UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059418 |
|---|---|
| Receipt number | R000067947 |
| Scientific Title | Assessing the Effectiveness of hot water immersion on thermoregulation in a hot environment |
| Date of disclosure of the study information | 2025/10/16 |
| Last modified on | 2025/10/15 13:53:40 |
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Basic information
Public title
The Effects of hot water immersion for preventing heatstroke
Acronym
The Effects of hot water immersion
Scientific Title
Assessing the Effectiveness of hot water immersion on thermoregulation in a hot environment
Scientific Title:Acronym
Assessing the Effectiveness of hot water immersion
Region
| Japan |
Condition
Condition
Not selected
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the effects of two different bathing methods and examine the differences in thermoregulation in a hot environment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
rectal temperature, sweating, blood flow
Key secondary outcomes
sweating begins, sweat composition, heart rate, skin temperature
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Bathing for 10 minutes at 41 celsius for 2 weeks
Interventions/Control_2
Shower bath for washing only
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
| 69 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy men aged 18 to 69
Those who usually shower or bathe in a bathtub less than twice a week
Those with a bathtub suitable for full-body bathing at home
Those who can cycle an exercise bike for 30 minutes at hot environment
Those who can provide written consent after receiving an explanation of the study details prior to the study
Those who can shower or bathe in a bathtub for two consecutive weeks at the start of the study
Those who can insert a rectal temperature probe themselves
Key exclusion criteria
Those who exercise regularly
Those with skin problems
Those with extremely irregular lifestyle habits, including eating and sleeping habits
Those who are participating in other clinical trials or monitors at the start of this study, or who plan to participate in other clinical trials or monitors during the planned period of this study
Those using a pacemaker, Holter monitor, or cardiopulmonary bypass
Those with a history of cardiovascular disease (myocardial infarction, angina pectoris, heart failure, arrhythmia, arteriosclerosis, stroke, varicose veins, hypertension), rectal disease (inflammatory bowel disease, post-rectal surgery, etc.), perianal inflammation and bleeding, hemorrhoids, or kidney disease (chronic glomerulonephritis, diabetic nephropathy, renal failure, nephrotic syndrome)
Those who have fallen asleep while bathing, or who have experienced dizziness or fainting during or after bathing
Those deemed ineligible by the study director or investigators
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Nakanishi |
Organization
Bathclin corporation
Division name
Product development department
Zip code
3050033
Address
29-9, Higashiarai, Tsukuba, Ibaraki
TEL
029-861-0160
nakanishi_nobuyuki@bathclin.co.jp
Public contact
Name of contact person
| 1st name | Misuzu |
| Middle name | |
| Last name | Kotsugai |
Organization
Bathclin corporation
Division name
Product development department
Zip code
3050033
Address
29-9, Higashiarai, Tsukuba, Ibaraki
TEL
029-861-0160
Homepage URL
kotsugai_misuzu@bathclin.co.jp
Sponsor or person
Institute
Bathclin corporation
Institute
Department
Personal name
Funding Source
Organization
Not selected
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Institute for Environmental Studies, Japan
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba palace Clinic
Address
Daiwa A Hamamatsucho building 6F, Hamamatsucho1-9-10, minatoku, Tokyo
Tel
03-5408-1590
shiba_palace@s-palace-clinic.com
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
| 2025 | Year | 10 | Month | 16 | 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
| 2025 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2026 | Year | 05 | 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
| 2025 | Year | 10 | Month | 15 | Day |
Last modified on
| 2025 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067947
