UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057184 |
|---|---|
| Receipt number | R000065367 |
| Scientific Title | Effects of axillary and inguinal cooling on core body temperature and thermoregulatory responses |
| Date of disclosure of the study information | 2026/03/31 |
| Last modified on | 2025/03/02 12:44:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Physical effects of cooling the armpit and groin
Acronym
Armpit and groin cooling study
Scientific Title
Effects of axillary and inguinal cooling on core body temperature and thermoregulatory responses
Scientific Title:Acronym
Axillary and Inguinal Cooling Study (AIC study)
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effects of axillary and inguinal region cooling on core body temperature and thermoregulatory responses in healthy adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tympanic temperature
Intestinal temperature
Blood pressure
Heart rate
Skin blood flow
Metabolic rate
Skin temperature
Thermal comfort and thermal sensation
Key secondary outcomes
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Cooling of the axillary and inguinal regions using ice packs
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male
Key inclusion criteria
Without any health issues
Key exclusion criteria
Presence of medical conditions requiring ongoing treatment
Current smoking status
Scheduled for MRI examination
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Mayumi |
| Middle name | |
| Last name | Matsuda-Nakamura |
Organization
Kawasaki City College of Nursing
Division name
School of Nursing
Zip code
212-0054
Address
4-30-1 Ogura,Saiwai-ku, Kawasaki-shi, Kanagawa, Japan
TEL
044-587-3500
matsuda-m@kawasaki-cn.ac.jp
Public contact
Name of contact person
| 1st name | Mayumi |
| Middle name | |
| Last name | Matsuda-Nakamura |
Organization
Kawasaki City College of Nursing
Division name
School of Nursing
Zip code
212-0054
Address
4-30-1 Ogura,Saiwai-ku, Kawasaki-shi, Kanagawa, Japan
TEL
044-587-3500
Homepage URL
matsuda-m@kawasaki-cn.ac.jp
Sponsor or person
Institute
Kawasaki City College of Nursing
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki City College of Nursing
Address
4-30-1 Ogura, Saiwai-ku, Kawasaki-shi, Kanagawa 212-0054, Japan
Tel
044-587-3500
matsuda-m@kawasaki-cn.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 | 03 | Month | 31 | 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 | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2027 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 03 | Month | 02 | Day |
Last modified on
| 2025 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065367
