UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049053 |
|---|---|
| Receipt number | R000055889 |
| Scientific Title | Does a forest park in urban area have a stress reduction effect? |
| Date of disclosure of the study information | 2022/10/15 |
| Last modified on | 2023/03/30 17:39:43 |
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Basic information
Public title
Does a forest park in urban area have a stress reduction effect?
Acronym
Does a forest park in urban area have a stress reduction effect?
Scientific Title
Does a forest park in urban area have a stress reduction effect?
Scientific Title:Acronym
Does a forest park in urban area have a stress reduction effect?
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Measuring stress reduction in an urban forest park
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary amylases
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Walking in the park for a certain time
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
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Subjects who are 20 years of age or older at the time of obtaining consent
(2) Subjects who have obtained free and voluntary written consent based on a thorough understanding of this research
(3) Students in their fourth and third grades of the Laboratory of Forest Symbiosis, College of Bioresource Sciences, Nihon University, between April 1, 2022 and March 31, 2023
Key exclusion criteria
(1) Subjects who did not give their prior consent to participate in this study
(2) Subjects who refused during the middle of the study
(3) Subjects who withdrew their consent during or after the study
(4) Subjects who have become pregnant
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Katsuaki |
| Middle name | |
| Last name | Sugiura |
Organization
Nihon University
Division name
College of Bioresource Sciences
Zip code
252-0880
Address
1866 Kameino, Fujisawa, Kanagawa
TEL
0466-84-3670
sugiura.katsuaki@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Katsuaki |
| Middle name | |
| Last name | Sugiura |
Organization
Nihon University
Division name
College of Bioresource Sciences
Zip code
252-0880
Address
1866 Kameino, Fujisawa, Kanagawa
TEL
0466-84-3670
Homepage URL
sugiura.katsuaki@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Funding Source
Organization
Nihon University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
College of Bioresource Scienses, Nihon University
Address
1866 Kameino, Fujisawa, Kanagawa
Tel
0466-84-3670
sugiura.katsuaki@nihon-u.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
| 2022 | Year | 10 | Month | 15 | 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
11
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
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 28 | Day |
Last modified on
| 2023 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055889
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
