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

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 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


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

Value
https://center6.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