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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012328
Receipt No. R000014414
Scientific Title Radiation Dose of Nurses During Interventional Radiology Procedures
Date of disclosure of the study information 2013/11/18
Last modified on 2013/11/18

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Basic information
Public title Radiation Dose of Nurses During Interventional Radiology Procedures
Acronym Radiation Dose of Nurses During Interventional Radiology Procedures
Scientific Title Radiation Dose of Nurses During Interventional Radiology Procedures
Scientific Title:Acronym Radiation Dose of Nurses During Interventional Radiology Procedures
Region
Japan

Condition
Condition nursing tasks in interventional radiology procedures
Classification by specialty
Radiology Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare nurses' exposure depending on whether or not the nurses called to the operator prior to approaching the patient when performing nursing tasks associated with interventional radiology procedures.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Effective dose
Key secondary outcomes

Base
Study type

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 In the call group, the nurse first told the operator she was going to approach the patient each time she was about to do so.
Interventions/Control_2 In the no-call group, when the nurse was going to approach the patient she did so without saying anything to the operator.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All nursing tasks in interventional radiology procedures performed in our hospital during the period from March through May 2012
Key exclusion criteria None
Target sample size 93

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Komemushi
Organization Kansai Medical University, Takii Hospital
Division name Dept. of Radiology
Zip code
Address 10-15, Fumizono, Moriguchi, OSAKA, Japan
TEL 06-6992-1001
Email kome64@yo.rim.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Komemushi
Organization Kansai Medical University, Takii Hospital
Division name Dept. of Radiology
Zip code
Address 10-15, Fumizono, Moriguchi, OSAKA, Japan
TEL 06-6992-1001
Homepage URL
Email kome64@yo.rim.or.jp

Sponsor
Institute Kansai Medical University, Takii Hospital
Institute
Department

Funding Source
Organization Kansai Medical University, Dept. of Radiology
Organization
Division
Category of Funding Organization Self funding
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
2013 Year 11 Month 18 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
2012 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
2012 Year 05 Month 31 Day
Date of closure to data entry
2012 Year 06 Month 30 Day
Date trial data considered complete
2012 Year 07 Month 31 Day
Date analysis concluded
2012 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 11 Month 18 Day
Last modified on
2013 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014414

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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