UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055486 |
|---|---|
| Receipt number | R000061870 |
| Scientific Title | Comparative Study of Changes in Body Temperature, Moisturizing Effects, and Mood by Bathing using Electric Water Heater, Microbubble Bath |
| Date of disclosure of the study information | 2024/09/11 |
| Last modified on | 2024/09/11 17:41:35 |
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Basic information
Public title
Effect Verification Experiment with Electric Water Heater, Micro Bubble Bathing
Acronym
Effect Verification Experiment with Electric Water Heater, Micro Bubble Bathing
Scientific Title
Comparative Study of Changes in Body Temperature, Moisturizing Effects, and Mood by Bathing using Electric Water Heater, Microbubble Bath
Scientific Title:Acronym
Comparative Study of Changes in Body Temperature, Moisturizing Effects, and Mood by Bathing using Electric Water Heater, Microbubble Bath
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of different bathing methods on human body and mood
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body temperature
Heart rate
Stratum corneum water content
Key secondary outcomes
Questionnaire
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
1st: 40 degree Celsius Hot Bath for 10 Minutes
2nd: 40 degree Celsius Micro Bubble Bath for 10 Minutes
Interventions/Control_2
1st: 40 degree Celsius Micro Bubble Bath for 10 Minutes
2nd: 40 degree Celsius Hot Bath for 10 Minutes
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
| 49 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy Japanese subjects 20 years old or more and less than 49 years old who have written informed consent
(2) Individuals who have given the written informed consent
Key exclusion criteria
(1) Individuals with a history of cardiac or cerebral disease, hypertension, etc.
(2) Pregnant, possibly pregnant, or lactating
(3) Individuals who are judged by the principal investigator to be inappropriate for this study as subjects based on the results of the background investigation
(4) Individuals who have a chronic disease and use medicines continuously, or have a history of serious diseases (e.g., diabetes, liver disease, kidney disease, heart disease, thyroid gland disease, adrenal gland disease, and/or metabolic disorder)
(5) Individuals who are unable to abstain from alcohol on the day before and on the day of the test, or who are forced to consume food products containing alcohol or alcoholic beverages
(6) Individuals who regularly take medicines that can affect mental status
(7) Individuals who have a history or current condition of drug or alcohol dependence
(8) Individuals who have a history of mental illness or epilepsy
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Shunsuke |
| Middle name | |
| Last name | Aoki |
Organization
Dentsu ScienceJam Inc.
Division name
Biomedical Information Research Group
Zip code
107-0052
Address
102 TRES Akasaka, 4-2-28 Akasaka, Minato-ku, Tokyo, Japan
TEL
03-6435-5316
shunsuke.aoki@jam.dentsu.co.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Aoki |
Organization
Dentsu ScienceJam Inc.
Division name
Biomedical Information Research Group
Zip code
107-0052
Address
102 TRES Akasaka, 4-2-28 Akasaka, Minato-ku, Tokyo, Japan
TEL
03-6435-5316
Homepage URL
shunsuke.aoki@jam.dentsu.co.jp
Sponsor or person
Institute
Dentsu ScienceJam Inc.
Institute
Department
Personal name
Funding Source
Organization
CORONA CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Healthcare Systems Co., Ltd.
DENTSU EAST JAPAN INC.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Committee of Dentsu ScienceJam Inc.
Address
102 TRES Akasaka, 4-2-28 Akasaka, Minato-ku, Tokyo, Japan
Tel
03-6435-5316
info@dentsusciencejam.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
| 2024 | Year | 09 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.corona.co.jp/news/newpro/2024microbubble.html
Number of participants that the trial has enrolled
12
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
Completed
Date of protocol fixation
| 2024 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 11 | Day |
Last modified on
| 2024 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061870
