UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034012
Receipt number R000038779
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
Date of disclosure of the study information 2018/09/03
Last modified on 2021/09/06 10:11:03

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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 or person

Institute

Center for Environment, Health and Field Sciences, Chiba University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038779


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name