UMIN-CTR Clinical Trial

Basic information
Public title	Physiological effects of seascapes from high-rise buildings on young women: comparison with urban landscapes, a crossover test
Acronym	Physiological effects of seascapes from high-rise buildings on young women: comparison with urban landscapes, a crossover test
Scientific Title	Physiological effects of seascapes from high-rise buildings on young women: comparison with urban landscapes, a crossover test
Scientific Title:Acronym	Physiological effects of seascapes from high-rise buildings on young women: comparison with urban landscapes, a crossover test
Region	Japan

Condition
Condition	Healthy person
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to clarify the effects of seascapes viewed from high-rise buildings using physiological and psychological indicators in female undergraduate and graduate students, comparing them with urban landscapes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) Prefrontal activity using near-infrared spectroscopy 2) Sympathetic and parasympathetic nervous activity as indicated by heart rate variability 3) Heart rate
Key secondary outcomes	1) Profile of Mood State (POMS2 short form) 2) Modified semantic differential method 3) Kwansei Gakuin (KG) daily life questionnaire 4) Trait Anxiety of State-Trait Anxiety Inventory

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Visual stimulation by seascape (90 s) -> Rest time -> Control: Visual stimulation by urban landscape (90 s)
Interventions/Control_2	Control: Visual stimulation by urban landscape (90 s) -> Rest time -> Visual stimulation by seascape (90 s)
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	Female
Key inclusion criteria	Healthy person
Key exclusion criteria	1) Subjects who are in poor physical condition 2) Subjects who have a respiratory illness 3) Subjects deemed inappropriate to participate in this study by the principle investigator 4) Subjects with menstruation during the study period
Target sample size	30

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
Email	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/
Email	hikei@chiba-u.jp

Sponsor
Institute	Center for Environment, Health and Field Sciences, Chiba University
Institute
Department

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	Nomura Real Estate Development Co., Ltd.
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
Email	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	2022 Year 06 Month 17 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	2019 Year 12 Month 29 Day
Date of IRB	2020 Year 01 Month 20 Day
Anticipated trial start date	2022 Year 05 Month 18 Day
Last follow-up date	2022 Year 06 Month 27 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 06 Month 17 Day
Last modified on	2022 Year 06 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054805

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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