UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012328 |
|---|---|
| Receipt number | 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 14:19:44 |
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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
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
kome64@yo.rim.or.jp
Sponsor or person
Institute
Kansai Medical University, Takii Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014414
