UMIN-CTR Clinical Trial

Basic information
Public title	The effects of visual stimulation in the form of interior wall images of knotted or knot-free wood using a large plasma display: Crossover test
Acronym	Visual stimulation effects of images of knotted or knot-free wood using a large plasma display
Scientific Title	The effects of visual stimulation in the form of interior wall images of knotted or knot-free wood using a large plasma display: Crossover test
Scientific Title:Acronym	Visual stimulation effects of images of knotted or knot-free wood using a large plasma display
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 visual stimulation provided by images of interior walls comprising knotted or knot-free wood using a large plasma display in 20 female university 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 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	6
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Visual stimulation using an interior wall image of knotted wood (90 s) -> Washout period -> Visual stimulation using an interior wall image of knot-free wood (90 s) -> Washout period -> Visual stimulation using a gray image (90 s)
Interventions/Control_2	Visual stimulation using an interior wall image of knotted wood (90 s) -> Washout period -> Visual stimulation using a gray image (90 s) -> Washout period -> Visual stimulation using an interior wall image of knot-free wood (90 s)
Interventions/Control_3	Visual stimulation using an interior wall image of knot-free wood (90 s) -> Washout period -> Visual stimulation using an interior wall image of knotted wood (90 s) -> Washout period -> Visual stimulation using a gray image (90 s)
Interventions/Control_4	Visual stimulation using an interior wall image of knot-free wood (90 s) -> Washout period -> Visual stimulation using a gray image (90 s) -> Washout period -> Visual stimulation using an interior wall image of knotted wood (90 s)
Interventions/Control_5	Visual stimulation using a gray image (90 s) -> Washout period -> Visual stimulation using an interior wall image of knotted wood (90 s) -> Washout period -> Visual stimulation using an interior wall image of knot-free wood (90 s)
Interventions/Control_6	Visual stimulation using a gray image (90 s) -> Washout period -> Visual stimulation using an interior wall image of knot-free wood (90 s) -> Washout period -> Visual stimulation using an interior wall image of knotted wood (90 s)
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	30 years-old >
Gender	Female
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 principle investigator 4) Subjects with menstruation during the study period 5) Subjects with visual acuity of <20/100 in both eyes
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yoshifumi Middle name Last name Miyazaki
Organization	Center for Environment, Health and Field Sciences, Chiba University
Division name	Natural Therapy Laboratory
Zip code	277-0882
Address	6-2-1 Kashiwa-no-ha, Kashiwa, Chiba 277-0882, Japan
TEL	04-7137-8113
Email	ymiyazaki@faculty.chiba-u.jp

Public contact
Name of contact person	1st name Yoshifumi Middle name Last name Miyazaki
Organization	Center for Environment, Health and Field Sciences, Chiba University
Division name	Natural Therapy Laboratory
Zip code	277-0882
Address	6-2-1 Kashiwa-no-ha, Kashiwa, Chiba 277-0882, Japan
TEL	04-7137-8113
Homepage URL	http://www.fc.chiba-u.jp/research/miyazaki/index.html
Email	ymiyazaki@faculty.chiba-u.jp

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

Funding Source
Organization	Tokyo wood cooperatives
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	1) Forestry and Forest Products Research Institute 2) Kyoto University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Ethics Committee 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	2018 Year 09 Month 03 Day

Related information
URL releasing protocol	https://www.mdpi.com/2071-1050/12/23/9898
Publication of results	Published

Result
URL related to results and publications	https://www.mdpi.com/2071-1050/12/23/9898
Number of participants that the trial has enrolled	28
Results	The knotty wood sedated the right prefrontal cortex activity compared with the control and enhanced parasympathetic nerve activity compared with before stimulation. Clear wood sedated the left prefrontal cortex activity compared with the control and suppressed sympathetic nerve activity compared with before stimulation.
Results date posted	2021 Year 09 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2020 Year 11 Month 23 Day
Baseline Characteristics	Female university students
Participant flow	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 principle investigator 4) Subjects with menstruation during the study period 5) Subjects with visual acuity of <20/100 in both eyes
Adverse events	None
Outcome measures	1) Prefrontal activity using near-infrared spectroscopy 2) Sympathetic and parasympathetic nervous system activity as indicated by heart rate variability 3) Heart rate 4) Profile of Mood State 5) Modified semantic differential method 6) Kwansei Gakuin (KG) daily life questionnaire 7) Trait Anxiety of State-Trait Anxiety Inventory
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2018 Year 09 Month 03 Day
Date of IRB	2018 Year 08 Month 20 Day
Anticipated trial start date	2018 Year 09 Month 03 Day
Last follow-up date	2018 Year 09 Month 13 Day
Date of closure to data entry	2019 Year 01 Month 11 Day
Date trial data considered complete	2020 Year 08 Month 13 Day
Date analysis concluded	2020 Year 08 Month 13 Day

Other
Other related information

Management information
Registered date	2018 Year 09 Month 03 Day
Last modified on	2021 Year 09 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038779