UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023745 |
|---|---|
| Receipt number | R000027350 |
| Scientific Title | The effects of interior material on fatigue of children and adolescents. |
| Date of disclosure of the study information | 2016/08/24 |
| Last modified on | 2016/08/24 13:21:42 |
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Basic information
Public title
The effects of interior material on fatigue of children and adolescents.
Acronym
The relationship between interior material and anti-fatigue.
Scientific Title
The effects of interior material on fatigue of children and adolescents.
Scientific Title:Acronym
The relationship between interior material and anti-fatigue.
Region
| Japan |
Condition
Condition
Healthy child
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of interior material on fatigue of children and adolescents.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison between data from autonomic nerve function and cognitive function measured by test room and standard room.
Key secondary outcomes
Subjective fatigue
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
To perform fatigue-inducing tasks and measurement of fatigue in test room.
Interventions/Control_2
To perform fatigue-inducing tasks and measurement of fatigue in standard room.
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
| 9 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy children and adolescents from the 5th grade to 9th grade.
Key exclusion criteria
None
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kei Mizuno |
Organization
Osaka City University
Division name
Center for Health Science Innovation
Zip code
Address
9F, Tower-C, Knowledge Capital, Grand Front Osaka, 3-1 Ofuka-cho, Kita-ku, Osaka 530-0011, Japan.
TEL
+81-6-6485-0288
chsi-b@ado.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kei Mizuno |
Organization
Osaka City University
Division name
Center for Health Science Innovation
Zip code
Address
9F, Tower-C, Knowledge Capital, Grand Front Osaka, 3-1 Ofuka-cho, Kita-ku, Osaka 530-0011, Japan.
TEL
+81-6-6485-0288
Homepage URL
chsi-b@ado.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Center for Health Science Innovation
Institute
Department
Personal name
Funding Source
Organization
Sekisui House, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
積水ハウス株式会社（大阪府）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 24 | 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
Completed
Date of protocol fixation
| 2014 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 13 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 10 | Month | 06 | Day |
Date trial data considered complete
| 2016 | Year | 08 | Month | 10 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 24 | Day |
Last modified on
| 2016 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027350
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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