UMIN-CTR Clinical Trial

Basic information
Public title	The effects of auditory stimulation by a sea environment: A crossover test
Acronym	The effects of auditory stimulation by a sea environment: A crossover test
Scientific Title	The effects of auditory stimulation by a sea environment: A crossover test
Scientific Title:Acronym	The effects of auditory stimulation by a sea environment: A crossover test
Region	Japan

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

Objectives
Narrative objectives1	We aim to clarify the psychological and physiological effects of auditory stimulation by a sea environment on male undergraduate and graduate students.
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	Auditory stimulation by ripple sound recorded at a beach in Miura City, Kanagawa, Japan (60 s) -> Rest time -> Control: Auditory stimulation by environmental sounds recorded at an urban intersection (60 s)
Interventions/Control_2	Control: Auditory stimulation by environmental sounds recorded at an urban intersection (60 s) -> Rest time -> Auditory stimulation by ripple sound recorded at a beach in Miura City, Kanagawa, Japan (60 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	Male
Key inclusion criteria	Healthy person
Key exclusion criteria	1) Subjects who are in a poor physical condition 2) Subjects who have a respiratory illness 3) Subjects deemed inappropriate to participate in this study by the principal investigator 4) Subjects who had hearing impairment
Target sample size	26

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	Japan Keirin Autorace foundation
Organization
Division
Category of Funding Organization	Non profit foundation
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
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	2021 Year 11 Month 12 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	Open public recruiting
Date of protocol fixation	2021 Year 10 Month 01 Day
Date of IRB	2021 Year 10 Month 22 Day
Anticipated trial start date	2021 Year 10 Month 22 Day
Last follow-up date	2021 Year 11 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	2021 Year 11 Month 12 Day
Last modified on	2021 Year 11 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052566