UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041123 |
|---|---|
| Receipt number | R000046832 |
| Scientific Title | The relaxing effect by viewing images of natural environment |
| Date of disclosure of the study information | 2020/07/20 |
| Last modified on | 2023/07/04 09:11:39 |
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Basic information
Public title
The relaxing effect by viewing images of natural environment
Acronym
The relaxing effect by viewing images of natural environment
Scientific Title
The relaxing effect by viewing images of natural environment
Scientific Title:Acronym
The relaxing effect by viewing images of natural environment
Region
| Japan |
Condition
Condition
na
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine changes in mood and neural activity of healthy subjects induced by viewing images of natural environments. In addition, by evaluating depression, anxiety symptoms, and cognitive functions etc., we will examine what kind of participant characteristics affects the relaxing effect of viewing images of the natural environments.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Current mood evaluated by the visual analog scale
2) Brain activation as evaluated by NIRS during image viewing
Key secondary outcomes
1) Comparison of heart rate and heart rate variability when viewing images of natural vs artificial environments
2) Identification of brain regions closely related to the relaxing effects of viewing images in the natural environment
3) The influence of personal characteristics such as mental health states and cognitive functions on the effect of viewing the image in the natural environment and the identification of its neural basis (eg, the more severe the depression, the greater the effect of viewing the image in the natural environment. )
4) Relationships among other personal characteristics
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Images of the natural environment such as forest, countryside, etc. are presented on a 27-inch high-resolution display for 3 minutes.
Interventions/Control_2
Images of artificial environments such as cities are presented on a 27-inch high-resolution display for 3 minutes.
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
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Age is 20 to 29 at the time of obtaining consent.
2) Regardless of gender.
3) A person who, after receiving a sufficient explanation before participating in this research, has a sufficient understanding and provided informed consent.
Key exclusion criteria
1) Those who are currently suffering from a mental illness or are currently undergoing medical examination (including those who are scheduled to undergo medical examination) by self-declaration.
2) Staff of our department who receive the personnel evaluation directly by the principal investigator of this study.
3) Those who are judged to be unsuitable as research subjects by the researcher in charge of the experimental sessions (for example, those who have participated in the pilot study of this research).
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Nakagawa |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Division of Neuropsychiatry, Department of Neuroscience
Zip code
7558505
Address
Minamikogushi 1-1-1, Ube, Yamaguchi, Japan
TEL
0836222255
brain@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Chong |
| Middle name | |
| Last name | Chen |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Division of Neuropsychiatry, Department of Neuroscience
Zip code
7558505
Address
Minamikogushi 1-1-1, Ube, Yamaguchi, Japan
TEL
0836222255
Homepage URL
brain@yamaguchi-u.ac.jp
Sponsor or person
Institute
Division of Neuropsychiatry, Department of Neuroscience, Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Institutional Review Board Committee in Yamaguchi University Hospital
Address
Minamikogushi 1-1-1, Ube, Yamaguchi, Japan
Tel
0836222428
clin_res@yamaguchi-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
山口大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/1660-4601/18/10/5500/htm
Number of participants that the trial has enrolled
30
Results
Viewing images of nature significantly increased comfortableness and relaxation compared to viewing images of built environments. Meanwhile, the concentration of oxy-Hb in the right OFC significantly decreased while viewing the images of nature compared to built environments.
Results date posted
| 2022 | Year | 07 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 07 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 16 | Day |
Last modified on
| 2023 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046832
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