UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055363 |
|---|---|
| Receipt number | R000063270 |
| Scientific Title | A cohort study of bathing-induced acute illness and its prognosis-ONSEN study (hOt spriNg reSearch in Emergecy aNd criticalcare)-. |
| Date of disclosure of the study information | 2024/08/29 |
| Last modified on | 2024/08/29 13:52:33 |
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Basic information
Public title
Project to Reduce Bathing-Related Accidents to Zero.
Acronym
Project to Reduce Bathing-Related Accidents to Zero.
Scientific Title
A cohort study of bathing-induced acute illness and its prognosis-ONSEN study (hOt spriNg reSearch in Emergecy aNd criticalcare)-.
Scientific Title:Acronym
ONSEN study (hOt spriNg reSearch in Emergecy aNd criticalcare)
Region
| Japan |
Condition
Condition
Acute illness related to bathing
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Objective: To investigate the relationship between the onset of acute illness caused by bathing, including hot springs, and the prognosis and severity of the illness.
Basic objectives2
Others
Basic objectives -Others
Examine the frequency of occurrence and risk of severity
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between type of bathing and incidence of prognosis
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases with "onsen" or "bathing" or "zao" or "bath" in the medical record
Key exclusion criteria
Exclude cases that are bath-related but not acute onset.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | masaki |
| Middle name | |
| Last name | nakane |
Organization
Yamagata University Hospital
Division name
Emergency and Crical Care Medicine
Zip code
9909585
Address
2-2-2 Iida-Nishi, Yamagata City
TEL
0236285400
yarimizu.kenya@gmail.com
Public contact
Name of contact person
| 1st name | kenya |
| Middle name | |
| Last name | yarimizu |
Organization
Yamagata University Hospital
Division name
Department of Anesthesiology
Zip code
9909585
Address
2-2-2 Iida-Nishi, Yamagata City
TEL
0236285400
Homepage URL
yarimizu.kenya@gmail.com
Sponsor or person
Institute
Yamagata University Hospital
Institute
Department
Personal name
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamagata University School of Medicine
Address
2-2-2 Iida-Nishi, Yamagata City
Tel
0236285400
yarimizu.kenya@gmail.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 | 08 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2040 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary endpoints:
1. grouping: Participants will be grouped based on type of bathing. The incidence of prognosis will be measured for each group. 2.
Statistical Analysis: Statistical methods such as Chi-square test, Fisher's exact test (for categorical variables), or ANOVA or MANOVA (for continuous variables) will be used to assess the impact of bathing type on the incidence of prognosis. Multivariate analysis may also be used to adjust for the effects of other covariates.
3. interpretation of results: interpretation of which type of bathing has a positive or negative impact on prognosis, with statistical significance.
Secondary endpoints:
Descriptive Statistics: Basic descriptive statistics such as mean, median, standard deviation, and range (minimum and maximum values) will be performed on the data collected. This will provide an overall picture of the bathing habits of the study subjects. 2.
Distribution visualization: Histograms and box plots are used to visualize the distribution of data on bathing. This allows us to identify any bias or outliers in the data. 3.
Subgroup analysis: If necessary, descriptive statistics can be performed for each subgroup, such as age, gender, health status, etc., to make comparisons between groups.
Management information
Registered date
| 2024 | Year | 08 | Month | 29 | Day |
Last modified on
| 2024 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063270
