UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062544 |
|---|---|
| Receipt number | R000071594 |
| Scientific Title | Secondary analysis of existing data on physiological adjustment effects: effects of visual stimulation with seascapes and urban landscapes viewed from a high-rise building on prefrontal cortex activity and autonomic nervous activity |
| Date of disclosure of the study information | 2026/08/10 |
| Last modified on | 2026/08/10 16:42:42 |
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Basic information
Public title
Secondary analysis of existing data on physiological adjustment effects: physiological effects of visual stimulation with seascapes and urban landscapes viewed from a high-rise building
Acronym
Secondary analysis of existing data on physiological adjustment effects: physiological effects of visual stimulation with seascapes and urban landscapes viewed from a high-rise building
Scientific Title
Secondary analysis of existing data on physiological adjustment effects: effects of visual stimulation with seascapes and urban landscapes viewed from a high-rise building on prefrontal cortex activity and autonomic nervous activity
Scientific Title:Acronym
Secondary analysis of existing data on physiological adjustment effects: effects of visual stimulation with seascapes and urban landscapes viewed from a high-rise building on prefrontal cortex activity and autonomic nervous activity
Region
| Japan |
Condition
Condition
Healthy persons.
This study is a secondary analysis of existing data obtained from the following studies already registered in UMIN-CTR: Physiological effects of seascapes from high-rise buildings on young women: comparison with urban landscapes, a crossover test (UMIN000048082) and Physiological effects of seascapes from high-rise buildings on young men: comparison with urban landscapes, a crossover test (UMIN000048325).
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
"This study is a secondary analysis of existing data obtained from previously conducted visual stimulation experiments. In the original studies, the physiological and psychological effects of visual stimulation with seascapes and urban landscapes viewed from a high-rise building were examined in young women and young men.
The present secondary analysis aims to examine the relationships between baseline physiological states before visual stimulation and physiological responses to visual stimulation with seascapes and urban landscapes, and to clarify the presence and extent of physiological adjustment effects, in which natural visual stimuli may modulate physiological responses according to each individual's baseline physiological state.
This study will not recruit new participants and will not involve any new intervention, measurement, or questionnaire. The data sources are the original studies registered as UMIN000048082 and UMIN000048325."
Basic objectives2
Others
Basic objectives -Others
Investigation of associations between baseline physiological states and physiological responses using existing data
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Left and right prefrontal cortex activity measured by near-infrared spectroscopy
2) Difference in prefrontal cortex activity between the left and right sides
3) Parasympathetic and sympathetic nervous activity calculated from heart rate variability
4) Heart rate
For each of these indices, associations between baseline physiological values before stimulation and differences in changes in physiological responses between seascape and urban landscape conditions will be assessed.
Key secondary outcomes
None
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Participants who took part in the original study Physiological effects of seascapes from high-rise buildings on young women: comparison with urban landscapes, a crossover test (UMIN000048082) or Physiological effects of seascapes from high-rise buildings on young men: comparison with urban landscapes, a crossover test (UMIN000048325)
2) Participants who completed both the seascape and urban landscape conditions
3) Participants for whom the physiological data required for the present analysis are available
Key exclusion criteria
1) Participants who did not complete either the seascape or urban landscape condition
2) Participants for whom the physiological data required for analysis are unavailable due to device malfunction, body movement, or other reasons
3)Participants who declined the use of their data in the original study or in the present secondary analysis
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Harumi |
| Middle name | |
| Last name | Ikei |
Organization
Chiba University
Division name
Center for Environment, Health and Field Sciences
Zip code
277-0882
Address
6-2-1 Kashiwa-no-ha, Kashiwa, Chiba 277-0882, Japan
TEL
04-7137-8184
hikei@chiba-u.jp
Public contact
Name of contact person
| 1st name | Harumi |
| Middle name | |
| Last name | Ikei |
Organization
Chiba University
Division name
Center for Environment, Health and Field Sciences
Zip code
277-0882
Address
6-2-1 Kashiwa-no-ha, Kashiwa, Chiba 277-0882, Japan
TEL
04-7137-8184
Homepage URL
http://www.fc.chiba-u.jp/research/naturetherapy/
hikei@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Nomura Real Estate Development Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committees of the Center for Environment, Health and Field Sciences, Chiba University
Address
6-2-1 Kashiwa-no-ha, Kashiwa, Chiba 277-0882, Japan
Tel
04-7137-8010
field-rinri@chiba-u.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
| 2026 | Year | 08 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective observational study using existing data obtained from previously conducted visual stimulation experiments. No new participants will be recruited, and no new intervention, measurement, or questionnaire will be conducted.
The data sources are the following studies already registered in UMIN-CTR: Physiological effects of seascapes from high-rise buildings on young women: comparison with urban landscapes, a crossover test (UMIN000048082) and Physiological effects of seascapes from high-rise buildings on young men: comparison with urban landscapes, a crossover test (UMIN000048325).
For each physiological index, this study will analyze the relationship between baseline physiological values before stimulation and differences in changes in physiological responses between seascape and urban landscape conditions, in order to examine the presence and extent of physiological adjustment effects. The analysis will include 50 participants for whom the required data are available among the 51 participants in the original studies.
Management information
Registered date
| 2026 | Year | 08 | Month | 10 | Day |
Last modified on
| 2026 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071594
