UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063215 |
|---|---|
| Receipt number | R000072349 |
| Scientific Title | Physiological and psychological effects of visual stimulation with wooden walls in children with developmental disabilities |
| Date of disclosure of the study information | 2026/10/08 |
| Last modified on | 2026/10/08 10:25:45 |
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Basic information
Public title
Physiological and psychological effects of visual stimulation with wooden walls in children with developmental disabilities: a crossover study
Acronym
Physiological and psychological effects of visual stimulation with wooden walls in children with developmental disabilities: a crossover study
Scientific Title
Physiological and psychological effects of visual stimulation with wooden walls in children with developmental disabilities
Scientific Title:Acronym
Physiological and psychological effects of visual stimulation with wooden walls in children with developmental disabilities
Region
| Japan |
Condition
Condition
Developmental disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effects of 60-second visual stimulation with a Japanese cedar-veneered wooden wall on prefrontal cortex activity, autonomic nervous activity, and subjective impressions in adolescents aged 13-18 years with developmental disorders, using a white wall as a control in a crossover study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Oxyhemoglobin concentration in the bilateral prefrontal cortex (baseline absolute values by time-resolved near-infrared spectroscopy and relative changes during rest and visual stimulation by portable near-infrared spectroscopy)
2) Autonomic nervous activity assessed by heart rate variability (HF and LF/HF)
3) Heart rate
Key secondary outcomes
1) Subjective ratings of liking and relaxation (10-point scales)
2) Behavioral characteristics measured by the Japanese version of the Matthews Youth Test for Health (MYTH)
3) Secondary analyses of individual differences in physiological adjustment effects
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Viewing a Japanese cedar-veneered wooden partition for 60 seconds, followed by an approximately 5-minute break and viewing a white partition for 60 seconds
Interventions/Control_2
Viewing a white partition for 60 seconds, followed by an approximately 5-minute break and viewing a Japanese cedar-veneered wooden partition for 60 seconds
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
| 13 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Male or female, aged 13-18 years
2) Participants and both parents born and raised in Japan, with Japanese as their native language
3) Attending child developmental support or after-school day services
4) Able to view the visual stimuli with or without vision correction
5) Diagnosed by a physician with a developmental disorder such as autism spectrum disorder, attention-deficit/hyperactivity disorder, or a learning disorder
6) Able to understand study procedures and participate in seated measurements and visual stimulation with staff assistance
7) Written parental consent and written assent from the participant
Key exclusion criteria
1) Respiratory conditions such as chronic rhinitis or asthma that may affect heart rate variability
2) Arrhythmia
3) Poor physical condition on the experiment day
4) Use of beta-blockers or other medication potentially affecting physiological responses (eligibility for other medications assessed by the principal investigator)
5) Considered unsuitable by the investigators
Target sample size
40
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
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/
hikei@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Harumi Ikei
Funding Source
Organization
Tokyo Log Wholesalers' Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
CI Partners Co., Ltd.; Colorful Link 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
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
| 2026 | Year | 10 | Month | 08 | 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
| 2026 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 08 | Day |
Last modified on
| 2026 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072349
