UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055515 |
|---|---|
| Receipt number | R000063411 |
| Scientific Title | Physical and mental effects of hot spring bathing facilities in Beppu City (2nd term) |
| Date of disclosure of the study information | 2024/09/17 |
| Last modified on | 2024/09/17 06:13:16 |
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Basic information
Public title
Physical and mental effects of hot spring bathing facilities in Beppu City (2nd term)
Acronym
Physical and mental effects of hot spring bathing facilities in Beppu City (2nd term)
Scientific Title
Physical and mental effects of hot spring bathing facilities in Beppu City (2nd term)
Scientific Title:Acronym
Physical and mental effects of hot spring bathing facilities in Beppu City (2nd term)
Region
| Japan |
Condition
Condition
Lifestyle-related diseases
Classification by specialty
| Medicine in general | Psychosomatic Internal Medicine | Geriatrics |
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to collect data before and after bathing in order to investigate how hot spring bathing affects the mind and body, and to use it as basic data for considering effective hot spring bathing methods depending on the purpose.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Subjective health status
Key secondary outcomes
Accelerated photoplethysmography, Heart rate valiability, Salivary amylase, Blood pressure, Flexibility
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
10
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Simple spring bathing
Interventions/Control_2
Chloride spring bathing
Interventions/Control_3
Sulphate spring bathing
Interventions/Control_4
Carbonate spring bathing
Interventions/Control_5
Acidic spring bahting
Interventions/Control_6
Sulphur spring bathing
Interventions/Control_7
Radioactive spring bathing
Interventions/Control_8
Ferruginous spring bathing
Interventions/Control_9
Iodidine containing spring bathing
Interventions/Control_10
Tap water bathing
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who have given consent to participate in the research
Key exclusion criteria
Exclude those who are prohibited from bathing by a doctor
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hikaru |
| Middle name | |
| Last name | Hara |
Organization
B-biz LINK
Division name
President
Zip code
874-0938
Address
1-3, Suehirocho, Beppu city, Oita
TEL
0977-77-4513
hori.hikaru@b-bizlink.or.jp
Public contact
Name of contact person
| 1st name | Hikaru |
| Middle name | |
| Last name | Hara |
Organization
B-biz LINK
Division name
Presdent
Zip code
874-0938
Address
1-3, Suehirocho, Beppu city, Oita
TEL
0977-77-4513
Homepage URL
hori.hikaru@b-bizlink.or.jp
Sponsor or person
Institute
B-biz LINK
Institute
Department
Personal name
Hikareu Hara
Funding Source
Organization
Beppu city
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Health & Research institute
Address
3-1-4 Nihonbshi Chuo Tokyo Japan
Tel
03-5290-1621
info@jph-ri.or.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
202402
Org. issuing International ID_1
Japan Health & Resedarch Institute
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 | 17 | 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 | 04 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2029 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2029 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2029 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 17 | Day |
Last modified on
| 2024 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063411
