UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051722 |
|---|---|
| Receipt number | R000059034 |
| Scientific Title | Physiological effects of touching wood with the palm of the hand on children with developmental disability: a crossover study |
| Date of disclosure of the study information | 2023/07/26 |
| Last modified on | 2023/12/19 14:37:28 |
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Basic information
Public title
Physiological effects of touching wood with the palm of the hand on children with developmental disability: a crossover study
Acronym
Physiological effects of touching wood with the palm of the hand on children with developmental disability: a crossover study
Scientific Title
Physiological effects of touching wood with the palm of the hand on children with developmental disability: a crossover study
Scientific Title:Acronym
Physiological effects of touching wood with the palm of the hand on children with developmental disability: a crossover study
Region
| Japan |
Condition
Condition
Developmental disability
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the effects of touching wood with the palm of the hand using physiolosical indicators on children with moderate to mild developmental disabilities who attend child development support services and after-school daycare.
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) Modified semantic differential method
2) Behavioral characteristics (Type A and B behavior patterns based on the Japanese version of the Type A questionnaire (MYTH) for children in elementary schools)
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Palm contact with unpainted wood (closed eyes, 1 min) -> Rest time -> Control: palm contact with urethane coating (thick coating) wood (closed eyes, 1 min)
Interventions/Control_2
Control: palm contact with urethane coating (thick coating) wood (closed eyes, 1 min) -> Rest time -> Palm contact with unpainted wood (closed eyes, 1 min)
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
| 12 | years-old | <= |
Age-upper limit
| 19 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Middle and high school students
2) Children who attend child development support services and after-school daycare
3) Children who are diagnosed with "Developmental disability (mild or moderate)" such as autism spectrum disorder, attention deficit hyperactivity disorder, or learning disability by a doctor
Key exclusion criteria
1) Children who are diagnosed with "developmental disorder (severe)" by a doctor
2) Children who are in a poor physical condition
3) Children who are deemed by the principal investigator to be unsuitable as a participant in the study
Target sample size
44
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.
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
| 2023 | Year | 07 | Month | 26 | 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
41
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
Completed
Date of protocol fixation
| 2023 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 26 | Day |
Last modified on
| 2023 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059034
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