UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057940 |
|---|---|
| Receipt number | R000063207 |
| Scientific Title | Verification of the effect of microbubble (microbubbles) bathing |
| Date of disclosure of the study information | 2025/05/23 |
| Last modified on | 2025/05/23 10:36:31 |
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Basic information
Public title
Verification of the effect of microbubble (microbubbles) bathing
Acronym
Verification of the effect of microbubble (microbubbles) bathing
Scientific Title
Verification of the effect of microbubble (microbubbles) bathing
Scientific Title:Acronym
Verification of the effect of microbubble (microbubbles) bathing
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Medicine in general | Cardiology | Neurology |
| Dermatology | Neurosurgery | Nursing |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, the participants will bathe in a microbubble bath group and a non-macrobubble group (normal warm bath), and investigate the effects of bathing using multiple indicators, such as subjective and physiological indices, in an exploratory manner.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Physiological evaluation indices (blood pressure and pulse rate, thermal effect, moisturizing effect, autonomic nerve activity, measurement of stress markers in saliva)
2) Psychological indicators
3) EEG measurement
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
microbubble bath
Interventions/Control_2
Often warm baths
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) 18 years of age or older
2) Healthy volunteers with no current medical conditions under treatment
3) Persons who can give written consent to participate in this study
Key exclusion criteria
(1) Those who have a disease that is currently being treated
(2) Patients with a history of cardiovascular or endocrine disease (thyroid, diabetes, etc.)
(3) Those with skin diseases or allergies
(4) Pregnant women.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | hiroko |
| Middle name | |
| Last name | jobosi |
Organization
Gunma University
Division name
Gunma University, Graduate School of Health Sciences
Zip code
371-8514
Address
3-39-22 Showa-machi, Maebashi, Gunma 371-8514, Japan
TEL
+81-27-220-8818
mitsuhiro.m@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | mitsuhiro |
| Middle name | |
| Last name | matsumoto |
Organization
Gunma University
Division name
Gunma University, Graduate School of Health Sciences
Zip code
371-8514
Address
3-39-22 Showa-machi, Maebashi, Gunma 371-8514, Japan
TEL
0272208818
Homepage URL
mitsuhiro.m@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University, Graduate School of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
self-procurement
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
Gunma University, Graduate School of Health Sciences
Address
3-39-22 Showa-machi, Maebashi, Gunma 371-8514, Japan
Tel
0272208818
mitsuhiro.m@gunma-u.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
| 2025 | Year | 05 | Month | 23 | 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
| 2024 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | 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 | 05 | Month | 23 | Day |
Last modified on
| 2025 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063207
