UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034294 |
|---|---|
| Receipt number | R000039094 |
| Scientific Title | The influence of contact with plants and visual stimulation with images of the natural environment on decision-making |
| Date of disclosure of the study information | 2018/09/28 |
| Last modified on | 2019/10/01 17:08:03 |
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Basic information
Public title
The influence of contact with plants and visual stimulation with images of the natural environment on decision-making
Acronym
The influence of nature contact on decision-making
Scientific Title
The influence of contact with plants and visual stimulation with images of the natural environment on decision-making
Scientific Title:Acronym
The influence of nature contact on decision-making
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate how potted plants and images of the natural environment affect decision-making in adults, through looking at behavioral and neural indices.
Basic objectives2
Others
Basic objectives -Others
Psychological effects
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Performance on decision-making tasks
2) Behavioral parameters estimated from the decision-making tasks
3) Brain activation and heart rate variability during decision-making tasks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
A potted-plants-transferring task is used for intervention, whereas a pot-transferring task with pots of the same weight but without plants is used for the control task. Plants intervention and control intervention are crossoverred between subjects.
Interventions/Control_2
Images of the natural environment vs urban scenes. Intervention with images of nature and intervention with control images are crossoverred between subjects.
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) By self-declaration, those with visual acuity (corrective visual acuity is acceptable) of 0.6 or more (colored eyeglasses or color contacts not allowed) and without any color vision disorder.
2) Persons who signed written consent by their free will with sufficient understanding after receiving sufficient explanation for the participation of this research.
Key exclusion criteria
1) By self-declaration, persons who have mental disorders and serious physical disorders, past history of neurodegenerative diseases, or are currently under treatment.
2) By self-declaration, persons whose first-degree relatives have any history of mental illness.
3) Despite self-declaring that there is no history of mental illness, persons who are judged to have a mental illness with an interview by a research staff (using MINI).
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin Nakagawa |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Division of Neuropsychiatry
Zip code
Address
MinamiKogushi 1-1-1, Ube
TEL
0836-22-2255
brain@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chong Chen |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Division of Neuropsychiatry
Zip code
Address
MinamiKogushi 1-1-1, Ube
TEL
0836-22-2255
Homepage URL
brain@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Graduate School of Medicine, Division of Neuropsychiatry
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
Address
Tel
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
| 2018 | Year | 09 | Month | 28 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 27 | Day |
Last modified on
| 2019 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039094
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| Registered date | File name |
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| Registered date | File name |
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