UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051668 |
|---|---|
| Receipt number | R000058963 |
| Scientific Title | Effects of forest bathing on the endocrine system: Effects of forest bathing on subjects showing depression/depressive tendency |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2023/11/09 11:05:15 |
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Basic information
Public title
Effects of forest bathing on the endocrine system: Effects of forest bathing on subjects showing depression/depressive tendency
Acronym
Effects of forest bathing on subjects showing depression/depressive tendency
Scientific Title
Effects of forest bathing on the endocrine system: Effects of forest bathing on subjects showing depression/depressive tendency
Scientific Title:Acronym
Effects of forest bathing on subjects showing depression/depressive tendency
Region
| Japan |
Condition
Condition
depression/depressive tendencies
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines the effects of forest bathing on the endocrine system in patients with depression/depressive tendencies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Serotonin
Key secondary outcomes
adrenaline, noradrenaline, dopamine
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Forest bathing
Interventions/Control_2
City walk
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
| 67 | years-old | > |
Gender
Female
Key inclusion criteria
1. Subjects aged between 20 and 67
2. Self-Rating Depression Scale (SDS): Subjects with a score of 40-59, regardless of whether they are taking antidepressants or anti-anxiety drugs.
3. Those who can participate in a 3-day/2-night forest bathing group trip on their own.
4. Those who obtained consent for this research
Key exclusion criteria
Subjects judged inappropriate for participation in this research by the principal investigator or research co-investigators
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Qing |
| Middle name | |
| Last name | Li |
Organization
Nippon Medical School Hospital
Division name
Department of Rehabilitation Medicine
Zip code
1138603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
0338222131
qing-li@nms.ac.jp
Public contact
Name of contact person
| 1st name | Qing |
| Middle name | |
| Last name | Li |
Organization
Nippon Medical School
Division name
Hospital
Zip code
1138603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
0338222131
Homepage URL
qing-li@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Qing Li
Funding Source
Organization
Vehicle Racing Public Interest Fund Memorial Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon medical School
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
Tel
0338222131
qing-li@nms.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
| 2024 | Year | 04 | Month | 01 | 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
31
Results
Participants Recruitment Closed - Study Ongoing
Results date posted
| 2023 | Year | 07 | Month | 20 | Day |
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 25 | Day |
Date trial data considered complete
| 2024 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 20 | Day |
Last modified on
| 2023 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058963
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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