UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052661 |
|---|---|
| Receipt number | R000060091 |
| Scientific Title | Effects of viewing in a rose garden on autonomic nervous activity in children with developmental disabilities : a crossover study |
| Date of disclosure of the study information | 2023/10/31 |
| Last modified on | 2023/10/31 12:02:40 |
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Basic information
Public title
Effects of viewing in a rose garden on autonomic nervous activity in children with developmental disabilities : a crossover study
Acronym
Effects of viewing in a rose garden on autonomic nervous activity in children with developmental disabilities : a crossover study
Scientific Title
Effects of viewing in a rose garden on autonomic nervous activity in children with developmental disabilities : a crossover study
Scientific Title:Acronym
Effects of viewing in a rose garden on autonomic nervous activity in children with developmental disabilities : 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 determine the effects of short views in the rose garden on autonomic nervous activity in children with moderate and mild developmental disabilities who attend or have attended developmental support and after-school day services.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Sympathetic and parasympathetic nervous activity as indicated by heart rate variability
2) 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
Viewing in the rose garden (3 minutes) -> Rest time -> Control: Viewing in the city (3 minutes)
Interventions/Control_2
Control: Viewing in the city (3 minutes) -> Rest time -> Viewing in the rose garden (3 minutes)
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) Children who attend or have attended child development support services and after-school daycare
2) 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
30
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
hikei@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology, Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
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 | 10 | Month | 31 | 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
Open public recruiting
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 | 10 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 11 | 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
| 2023 | Year | 10 | Month | 31 | Day |
Last modified on
| 2023 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060091
