UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056483 |
|---|---|
| Receipt number | R000064547 |
| Scientific Title | Effects of Nature Experience and Onsen (Hot Springs) Bathing Experience in Satoyama on Mental and Physical Well-being |
| Date of disclosure of the study information | 2024/12/20 |
| Last modified on | 2024/12/18 09:34:23 |
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Basic information
Public title
Effects of Nature Experience and Onsen (Hot Springs) Bathing Experience in Satoyama on Mental and Physical Well-being
Acronym
Effects of Nature Experience and Onsen (Hot Springs) Bathing Experience in Satoyama on Mental and Physical Well-being
Scientific Title
Effects of Nature Experience and Onsen (Hot Springs) Bathing Experience in Satoyama on Mental and Physical Well-being
Scientific Title:Acronym
Effects of Nature Experience and Onsen (Hot Springs) Bathing Experience in Satoyama on Mental and Physical Well-being
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects on the body and mind of a new hot spring experience program in Shuzenji that combines nature experiences in a satoyama with the health-promoting effects of bathing in a hot spring.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mood Inventory (@40 items: Sakano et al., 1994): Mood state
ROS (6 items: Fujisawa & Takayama, 2014): subjective sense of recovery
SVS (@4 items: Takayama, 2015): subjective vitality
SWLS (@5 items Diener, 1985 (Japanese version)): Satisfaction with life
VAS (@12 items: 10-point scale): Subjective health status
Key secondary outcomes
Autonomic nerve activity
Peripheral blood circulation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Forest bathing experience group
Interventions/Control_2
City walking experience group
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
| 30 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who have given consent to participate in the study.
Key exclusion criteria
Persons who are prohibited from taking a bath by a medical doctor will be excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ryuichi |
| Middle name | |
| Last name | Baba |
Organization
Whole Earth Nature School
Division name
Headquarter
Zip code
419-0305
Address
165 Simoyuno, Fujinomiya-shi, Shizuoka JAPAN
TEL
0544-66-0152
info@wens.gr.jp
Public contact
Name of contact person
| 1st name | Ryuichi |
| Middle name | |
| Last name | Baba |
Organization
Whole Earth Nature School
Division name
Headquarter
Zip code
419-0305
Address
165 Simoyuno, Fujinomiya-shi, Shizuoka JAPAN
TEL
0544-66-0152
Homepage URL
ryuichi.baba@wens.gr.jp
Sponsor or person
Institute
Whole Earth Nature School
Institute
Department
Personal name
Funding Source
Organization
Ministry of 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
Address
3-1-4, Nihonbaashi Chuo Tokyo JAPAN
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
| 2024 | Year | 12 | Month | 20 | 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 | 11 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 12 | Month | 18 | Day |
Last modified on
| 2024 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064547
