Protocol summary
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Study aim
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Determining the frequency of injuries caused by foreign objects in the medical staff before and after the training
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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The frequency of needlestick and sharp object incidents
General information
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Reason for update
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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.
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Acronym
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IRCT registration information
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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
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Registration date
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2024-04-18, 1403/01/30
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-09-21, 1403/06/31
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Expected recruitment end date
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2025-03-20, 1403/12/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The Effect Of Training Program On Injuries Caused By Sharp Objects In Health Care Workers in 2024 - 2025
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Public title
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The Effect Of Training Program On Injuries Caused By Sharp Objects In Health Care Workers
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
700
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-02-27, 1402/12/08
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Ethics committee reference number
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IR.IUMS.REC.1402.1086
Health conditions studied
1
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Description of health condition studied
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infectious disease, occupational disease
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ICD-10 code
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B16
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ICD-10 code description
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Acute hepatitis B
Primary outcomes
1
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Description
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The frequency of injuries caused by the sharp objects
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Timepoint
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Before the intervention and 6 months after the intervention
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Method of measurement
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Infection control checklist
Intervention groups
1
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Description
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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.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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The general results of the project are presented in aggregate form without mentioning the names of individuals
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When the data will become available and for how long
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after the study termination
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To whom data/document is available
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university centers' researchers
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Under which criteria data/document could be used
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If the researchers want to conduct a similar study, the results and methods will be available to them
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From where data/document is obtainable
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Negin Kassiri
neginkassiri@gmail.com
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What processes are involved for a request to access data/document
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From the time of sending the request, it will take about 2 working weeks to review your request and provide documents if possible.
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Comments
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