UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004713 |
|---|---|
| Receipt number | R000005608 |
| Scientific Title | Validity, reliability and applicability of Japanese versions of State Behavioral Scale among infants and young children |
| Date of disclosure of the study information | 2010/12/14 |
| Last modified on | 2014/07/14 16:36:36 |
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Basic information
Public title
Validity, reliability and applicability of Japanese versions of State Behavioral Scale among infants and young children
Acronym
Validity, reliability and applicability of Japanese versions of State Behavioral Scale among infants and young children
Scientific Title
Validity, reliability and applicability of Japanese versions of State Behavioral Scale among infants and young children
Scientific Title:Acronym
Validity, reliability and applicability of Japanese versions of State Behavioral Scale among infants and young children
Region
| Japan |
Condition
Condition
Pediatric Critical Care Patient
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop and test the reliability and validity of the Japanese version State Behavioral Scale (SBS) for use in describing sedation/agitation levels in infants and young patients
Basic objectives2
Others
Basic objectives -Others
To develop and test the reliability and validity of the Japanese version State Behavioral Scale (SBS) for use in describing sedation/agitation levels in infants and young patients
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
weighted kappa and intra class coefficients (ICC) are generated to assess interrater reliability of the eight dimension and VAS ratings.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 0 | years-old | <= |
Age-upper limit
| 7 | years-old | > |
Gender
Male and Female
Key inclusion criteria
6 wks to 6years of age patients
Key exclusion criteria
Excluded patients receiving neuromuscular blockade
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | tarou Mizutani |
Organization
University of Tsukuba Hospital
Division name
Emergency and Critical Care Department
Zip code
Address
Tennodai 2-1-1, Tsukuba, JAPAN.
TEL
028533900
gongehead@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Sakukramoto |
Organization
University of Tsukuba Hospital
Division name
ICU
Zip code
Address
Tennodai 2-1-1, Tsukuba, JAPAN.
TEL
028533900
Homepage URL
gongehead@yahoo.co.jp
Sponsor or person
Institute
University of Tsukuba Hospital Emergency and Critical Care Department
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 14 | 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
| 2010 | Year | 12 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 06 | Month | 01 | Day |
Other
Other related information
Completed
Management information
Registered date
| 2010 | Year | 12 | Month | 12 | Day |
Last modified on
| 2014 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005608
