UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058117 |
|---|---|
| Receipt number | R000066354 |
| Scientific Title | The effects of ONSEN stay therapy using wearable devices |
| Date of disclosure of the study information | 2025/06/09 |
| Last modified on | 2025/06/07 21:40:51 |
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Basic information
Public title
The effects of ONSEN stay therapy using wearable devices
Acronym
The effects of ONSEN stay therapy using wearable devices
Scientific Title
The effects of ONSEN stay therapy using wearable devices
Scientific Title:Acronym
The effects of ONSEN stay therapy using wearable devices
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to use wearable devices to collect objective data and clarify the physical and mental changes before and after staying at a hot spring resort(ONSEN stay), and to compare and analyse the physical and mental changes depending on whether or not the participants took part in activities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart rate and variability, blood oxygen concentration, skin surface temperature, sleep duration and quality, stress level (measured by wearable devices), Mood Inventory, ONSEN stay therapy self-administered questionnaire
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Stay at a hot spring resort without activities 3-4 days
Interventions/Control_2
Stay at a hot spring resort with activities (tennis planned) 3-4 days
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who have agreed to participate in the study
Those who are healthy
Those who are not prohibited from exercising or bathing
Key exclusion criteria
Those who are prohibited from exercising or bathing by their doctor
Those who are not feeling well
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Hayasaka |
Organization
Japan Health & Research Institute
Division name
Onsen Medical Science Research Center
Zip code
103-0027
Address
3-1-4-8F Nihonbashi Cyuou-ku Tokyo
TEL
03-5290-1621
info@jph-ri.or.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Hayasaka |
Organization
Japan Health & Research Institute
Division name
Onsen Medical Science Research Center
Zip code
103-0027
Address
3-1-4-8F Nihonbashi Cyuou-ku Tokyo
TEL
03-5290-1621
Homepage URL
info@jph-ri.or.jp
Sponsor or person
Institute
Japan Health & Research Institute
Institute
Department
Personal name
Funding Source
Organization
Ministry of the Environment
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Health & Research Institute IRB
Address
3-1-4-8F Nihonbashi Cyuou-ku Tokyo
Tel
03-5290-1621
info@jph-ri.or.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 | 06 | Month | 09 | 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 | 05 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2026 | 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 | 06 | Month | 07 | Day |
Last modified on
| 2025 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066354
