UMIN-CTR Clinical Trial

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
Email	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
Email	brain@yamaguchi-u.ac.jp

Sponsor
Institute	Yamaguchi University Graduate School of Medicine, Division of Neuropsychiatry
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039094