View older revisions Content changed at 2024-05-04, 1403/02/15

Protocol summary

Study aim
Determining the frequency of injuries caused by foreign objects in the medical staff before and after the training
Design
healthcare workers in teaching hospitals covered by Iran University of Medical Sciences will be included in the study with an available sampling method (700 people) with a before and after design.
Settings and conduct
At the beginning of the autumn and before the training course, the frequency of sharp incidents will be recorded as a pre-intervention stage. At the end of the year and after the intervention, the frequency of the sharp accidents will be evaluated and recorded as the results of the post-intervention stage.
Participants/Inclusion and exclusion criteria
this clinical trial study will be conducted with a before and after design and after acquiring the code of ethics, for health care workers. The inclusion criteria include all people working as medical staff in the mentioned hospital at the time of the study and who want to attend this study. Among the people included in the study, the personnel who were not present in the hospital during the one year of the study due to the temporary interruption of job duties (long and transitional leave) or the permanent end of the employment period (retirement and dismissal) will be excluded from the study.
Intervention groups
all the healthcare workers after the intervention were considered as the test group, and the same were considered as the control group before the intervention. The intervention referred to in this study, the training course includes a lecture in a two-hour session and the installation of relevant educational posters at the hospital to prevent needle stick injuries and sharp accidents according to NIOSH guidelines.
Main outcome variables
The frequency of needlestick and sharp object incidents

General information

Reason for update
Since all the personnel of a hospital do not have the opportunity or desire to participate in our study, in order to reach the desired sample size, it was decided to hold the said educational program in several educational hospitals. Since the present project will be carried out in several hospitals, the title was changed. Also, in the section "on patient care centers", educational hospitals covered by Iran University of Medical Sciences were mentioned.
Acronym
IRCT registration information
IRCT registration number: IRCT20240414061486N1
Registration date: 2024-04-18, 1403/01/30
Registration timing: prospective

Last update: 2024-05-04, 1403/02/15
Update count: 1
Registration date
2024-04-18, 1403/01/30
Registrant information
Name
Negin Kassiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 3170
Email address
kassiri.n@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-21, 1403/06/31
Expected recruitment end date
2025-03-20, 1403/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of Training Program On Injuries Caused By Sharp Objects In Health Care Workers in 2024 - 2025
Public title
The Effect Of Training Program On Injuries Caused By Sharp Objects In Health Care Workers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All the people who are working as medical staff in the mentioned hospital at the time of starting the study
Exclusion criteria:
Lack of consent to participate in the study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 700
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethics committee of Iran university of medical sciences
Street address
occupational medicine department, faculty of medicine, Iran university of medical sciences, Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2024-02-27, 1402/12/08
Ethics committee reference number
IR.IUMS.REC.1402.1086

Health conditions studied

1

Description of health condition studied
infectious disease, occupational disease
ICD-10 code
B16
ICD-10 code description
Acute hepatitis B

Primary outcomes

1

Description
The frequency of injuries caused by the sharp objects
Timepoint
Before the intervention and 6 months after the intervention
Method of measurement
Infection control checklist

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this study and based on the before and after design, all the personnel of the treatment staff after the intervention were considered as the test group and the same people were considered as the control group before the intervention. The intervention referred to in this study, the training course includes a lecture in a two-hour session in person and the installation of relevant educational posters at the hospital to prevent needle stick injuries and sharp accidents according to NIOSH guidelines.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Teaching hospitals covered by Iran University of Medical Sciences
Full name of responsible person
Negin Kassiri
Street address
Iran university of medical sciences, Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 1021
Email
neginkassiri@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Negin Kassiri
Street address
occupational medicine department, faculty of medicine, Iran university of medical sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8862 2682
Email
neginkassiri@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Negin Kassiri
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Occupational Medicine
Street address
Department of Occupational Medicine, school of Medicine, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8862 2682
Email
neginkassiri@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Negin Kassiri
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Occupational Medicine
Street address
Iran university of medical sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8862 2682
Email
neginkassiri@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Negin Kassiri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Occupational Medicine
Street address
Occupational Medicine Department, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 3170
Fax
+98 21 8862 2682
Email
kassiri.n@iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The general results of the project are presented in aggregate form without mentioning the names of individuals
When the data will become available and for how long
after the study termination
To whom data/document is available
university centers' researchers
Under which criteria data/document could be used
If the researchers want to conduct a similar study, the results and methods will be available to them
From where data/document is obtainable
Negin Kassiri neginkassiri@gmail.com
What processes are involved for a request to access data/document
From the time of sending the request, it will take about 2 working weeks to review your request and provide documents if possible.
Comments
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