Tokyo, Oct. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063215) titled 'Physiological and psychological effects of visual stimulation with wooden walls in children with developmental disabilities: a crossover study' on Oct. 8.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Placebo
Primary Sponsor:
Institute - Chiba University
Condition:
Condition - Developmental disorders
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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
Eligibility:
Age-lower limit - 13
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 Size - 40
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072349
Disclaimer: Curated by HT Syndication.
