To investigate the effect of needle magnet on risk of scrub nurses' needle contact and dispersion of sharp things in heart, thoracic and organ transplantation surgery.
Objective: To investigate the effect of needle magnet on risk of scrub nurses' needle contact and dispersion of sharp things in heart, thoracic and organ transplantation surgery. Based on inclusion and exclusion criteria, 80 scrub nurses are randomly selected and randomly divided into two groups; intervention and control. In the intervention group, participants receive needle magnet before the start of operation . Scrub nurses' needle contact and dispersion of sharp things before and after using needle magnet is measured by the questionnaire that verified its validity and reliability previously. In the control group there is no intervention.
Design
Clinical trial with a control group, randomized, parallel group
Settings and conduct
Namazi Hospital
Participants/Inclusion and exclusion criteria
Scrub Nurses
Intervention groups
In the intervention group, participants receive needle magnet before the start of operation . Scrub nurses' needle contact and dispersion of sharp things before and after using needle magnet is measured by the questionnaire that verified its validity and reliability previously.
Main outcome variables
Needle Stick Injury
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180109038286N1
Registration date:2018-02-13, 1396/11/24
Registration timing:registered_while_recruiting
Last update:2018-02-13, 1396/11/24
Update count:0
Registration date
2018-02-13, 1396/11/24
Registrant information
Name
Farzaneh Rezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3821 9747
Email address
farzanehrezaei90@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To investigate the effect of needle magnet on risk of scrub nurses' needle contact and dispersion of sharp things in heart, thoracic and organ transplantation surgery.
Public title
To investigate the effect of needle magnet on risk of scrub nurses' needle contact and dispersion of sharp things in heart, thoracic and organ transplantation surgery.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1. Willingness to participate in the study
2. Scrub nurses in the morning and evening shifts
3. Scrub nurses in Heart and Thoracic and organs Transplantation Surgery
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Street, Shiraz
City
Shiraz
Province
Fars
Postal code
713451978
Approval date
2017-06-11, 1396/03/21
Ethics committee reference number
IR.SUMS.REC.1396.57
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
2
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Needle Stick Injuries during surgery
Timepoint
Before and after using the needle magnet
Method of measurement
Made Questionnaire
2
Description
Dispersion of sharp things during surgery
Timepoint
Before and after using the needle magnet
Method of measurement
Made Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, participants receive needle magnet before the start of operation . Scrub nurses' needle contact and dispersion of sharp things before and after using needle magnet is measured by the questionnaire that verified its validity and reliability previously.
Category
Diagnosis
2
Description
Control group: There is no intervention in the control group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Hashem Rahmati
Street address
Namazi squre, Namazi Hospital
City
Shiraz
Province
Fars
Postal code
713451978
Phone
+98 71 3647 4255
Email
farzanehrezaei90@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
713451978
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Rezaei
Position
Master Student Operating Room
Latest degree
Bachelor
Other areas of specialty/work
Operating Room
Street address
Namazi Square
City
Shiraz
Province
Fars
Postal code
713451978
Phone
+98 71 3647 3051
Email
farzanehrezaei90@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Rezaei
Position
Master Student Operating Room
Latest degree
Bachelor
Other areas of specialty/work
Operating Room
Street address
Namazi Square
City
Shiraz
Province
Fars
Postal code
713451978
Phone
+98 71 3647 3051
Email
farzanehrezaei90@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Rezaei
Position
Master Student Operating Room
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
Namazi Square
City
Shiraz
Province
Fars
Postal code
7168747377
Phone
+98 71 3647 3051
Email
farzanehrezaei90@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available