UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049402 |
|---|---|
| Receipt number | R000056251 |
| Scientific Title | A Study of Nature Based Stress Management (NBSM) in a Mountain Village Area in Tokyo - Stress Management Salutogenesis Theory |
| Date of disclosure of the study information | 2022/11/02 |
| Last modified on | 2023/05/05 06:04:09 |
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Basic information
Public title
Research on natural environment and mental health in a mountain village area in Tokyo
Acronym
Research on natural environment and mental health in a mountain village area in Tokyo
Scientific Title
A Study of Nature Based Stress Management (NBSM) in a Mountain Village Area in Tokyo - Stress Management Salutogenesis Theory
Scientific Title:Acronym
A Study of Nature Based Stress Management (NBSM) in a Mountain Village Area in Tokyo - Stress Management Salutogenesis Theory
Region
| Japan |
Condition
Condition
Healthy Workers
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to implement a nature-based program in Hinohara Village and to identify short-term evaluations.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to implement a nature-based program in Hinohara Village and to identify short-term evaluations. By evaluating the stress management program, it is expected that suggestions for new stress management measures can be obtained.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Work Engagement(before program implementation, one month after program completion)
Key secondary outcomes
Restorative Outcome Scale,Somatic Symptom Scale8,Program Evaluation,the Feelings toward Nature Scale, POMS2, SOC, K6, AIS, Changes in Perception of Nature
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Programs that make use of nature Level1
(1 time. about 3 hours)
Interventions/Control_2
Programs that make use of nature Level2
(1 time. about 3 hours)
Interventions/Control_3
Programs that make use of nature Level3
(1 time. about 3 hours)
Interventions/Control_4
Programs that make use of nature Level4
(1 time. about 3 hours)
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
| 59 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Workers (currently employed) in their 20s to 50s living in the Tokyo metropolitan area
(2) Those who are able to participate in the event at Oine House in Hinohara Village, Tokyo.
(3) Those in good health
(4) Those who live in urban areas and do not have opportunities to experience the natural environment such as green spaces, forests, and rivers nearby.
Key exclusion criteria
(1) Women who are pregnant
(2) Those who are on a leave of absence
(3) Those with illnesses that may suddenly change or a history of such illnesses
(4) Those who are currently undergoing outpatient treatment at a psychiatry or psychosomatic medicine clinic or are participating in a rework program.
(5) Those who regularly use outdoor activities such as camping and mountain climbing on holidays and public holidays.
(6) Those who have any of the following symptoms on the day of the event.(Strong symptoms such as high fever/Symptoms of taste and smell disorder) .Other symptoms that may be considered as cold such as fever, cough, sputum, sore throat, nasal discharge/nasal obstruction, headache, joint/muscle pain, diarrhea, nausea/vomiting, etc.
(7) Those who have had a fever of 37.5 or higher within 2 weeks.
(8) Patients who have traveled abroad within 2 weeks.
(9) Those who have been diagnosed as COVID-19 infected persons/concentrated contacts/contact persons.
(10) Those who have been diagnosed or are suspected to have been diagnosed as COVID-19 infected person/concentrated contact person/contact person in their immediate vicinity.
(11) Those who have not completed the follow-up survey since their last participation in the program.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shinichiro |
| Middle name | |
| Last name | Sasahara |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Occupational and Aerospace Psychiatry Group
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba City, Ibaraki Prefecture
TEL
029-853-6025
ssh1@nifty.com
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Sasahara |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Occupational and Aerospace Psychiatry Group
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba City, Ibaraki Prefecture
TEL
029-853-6025
Homepage URL
m-ishitsuka@nifty.com
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Ethics Committee of the Medical and Health Sciences
Address
1-1-1 Tennodai, Tsukuba City, Ibaraki Prefecture
Tel
029-853-3308
sien.ningenss@un.tsukuba.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 | 11 | Month | 02 | 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
| 2022 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2022 | Year | 11 | Month | 02 | Day |
Last modified on
| 2023 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056251
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| Registered date | File name |
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