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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038730
Receipt No. R000044156
Scientific Title The effects of visual stimulation in the knotted wood using a large plasma display: Crossover test
Date of disclosure of the study information 2019/11/29
Last modified on 2019/11/29

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Basic information
Public title The effects of visual stimulation in the knotted wood using a large plasma display
Acronym The effects of visual stimulation in the knotted wood
Scientific Title The effects of visual stimulation in the knotted wood using a large plasma display: Crossover test
Scientific Title:Acronym The effects of visual stimulation in the knotted wood
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 knotted wood using a large plasma display on 20s 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 image of knotted wood (high proportion of knotted) (90 s) -> Rest time -> Visual stimulation using an image of knotted wood (low proportion of knotted) (90 s) -> Rest time -> Visual stimulation using an image of knot-free wood (90 s)
Interventions/Control_2 Visual stimulation using an image of knotted wood (high proportion of knotted) (90 s) -> Rest time -> Visual stimulation using an image of knot-free wood (90 s) -> Rest time -> Visual stimulation using an image of knotted wood (low proportion of knotted) (90 s)
Interventions/Control_3 Visual stimulation using an image of knotted wood (low proportion of knotted) (90 s) -> Rest time -> Visual stimulation using an image of knotted wood (high proportion of knotted) (90 s) -> Rest time -> Visual stimulation using an image of knot-free wood (90 s)
Interventions/Control_4 Visual stimulation using an image of knotted wood (low proportion of knotted) (90 s) -> Rest time -> Visual stimulation using an image of knot-free wood (90 s) -> Rest time -> Visual stimulation using an image of knotted wood (high proportion of knotted) (90 s)
Interventions/Control_5 Visual stimulation using an image of knot-free wood (90 s) -> Rest time -> Visual stimulation using an image of knotted wood (high proportion of knotted) (90 s) -> Rest time -> Visual stimulation using an image of knotted wood (low proportion of knotted) (90 s)
Interventions/Control_6 Visual stimulation using an image of knot-free wood (90 s) -> Rest time -> Visual stimulation using an image of knotted wood (low proportion of knotted) (90 s) -> Rest time -> Visual stimulation using an image of knotted wood (high proportion of knotted) (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 Harumi
Middle name
Last name Ikei
Organization Center for Environment, Health and Field Sciences, Chiba University
Division name Nature Therapy Laboratory
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 Center for Environment, Health and Field Sciences, Chiba University
Division name Nature Therapy Laboratory
Zip code 277-0882
Address 6-2-1 Kashiwa-no-ha, Kashiwa, Chiba 277-0882, Japan
TEL 04-7137-8184
Homepage URL
Email hikei@chiba-u.jp

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

Funding Source
Organization TOKYO LOG WHOLESALERS' ASSOCIATION
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Kyoto University
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
2019 Year 11 Month 29 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 11 Month 29 Day
Date of IRB
2019 Year 11 Month 29 Day
Anticipated trial start date
2019 Year 11 Month 29 Day
Last follow-up date
2019 Year 12 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 11 Month 29 Day
Last modified on
2019 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044156

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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