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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004713
Receipt No. 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

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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
Email 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
Email gongehead@yahoo.co.jp

Sponsor
Institute University of Tsukuba Hospital Emergency and Critical Care Department
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005608

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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