Needlestick InjuriesNCT05211999
The Effect of Precede-Proceed Model Based Simulation Experience in Needlestick and Sharps Injuries Among Nurses
A study testing Precede-Proceed Model Based Simulation Experience in people with Needlestick Injuries, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
Healthcare workers are exposed to many important risks that will negatively affect their health in their working environment. Among these risks, the most important threat is needlestick injuries. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Needlestick Injuries
- What is being tested?
- Precede-Proceed Model Based Simulation Experience
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 30 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 0-1 years of experience in the profession,
- Nurses who volunteered to participate in the study,
Who cannot join
- Nurses who graduated from Acıbadem Mehmet Ali Aydınlar University
- Nurses who have worked in the profession for more than one year
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acibadem University
Istanbul, Eyalet/Yerleşke, 34360
About this study
Healthcare workers are exposed to many important risks that will negatively affect their health in their working environment. Among these risks, the most important threat is needlestick injuries. Needlestick injuries in healthcare workers with work-related injuries among studies, and the prevalence of injury remains high. In a study conducted by Gheshlagh et al. (2018), the prevalence of needlestick injuries in health workers was found to be 42.5%. It has been shown in studies conducted that the most common decision needlestick injuries among health workers are in nurses. In preventing injuries, preventing, and controlling negative behaviors related to the safe use of needlestick tools is among the most important strategies. In addition, the use of evidence obtained from interventional studies to prevent needlestick injuries in protection programs also plays an important role in prevention.
The importance of frequent and regular education about the subject has been mentioned especially in the studies conducted to prevent injuries. The World Health Organization (WHO) has published gold standards in the education of nurses and has recommended the use of electronic learning and simulation methods in the programs of nursing schools for learning and teaching according to these standards. It is important to use evidence-based practices to increase quality and competence by creating realistic clinical environments in nursing education. In this context, it is possible to use simulation-based experiences for educational purposes without exposure to infection control and employee safety in the clinical field.
In a study conducted by Nakamura et al. (2019), it was found that a simulation-based training program was effective in infection control. Due to the limited number of studies aimed at protecting the health of healthcare workers and controlling infection, more simulation-based studies are needed in this area. In addition, conducting model-based studies in developing behavior in health workers will also increase success. One of these models, the Precede-Process Model, is an important guide for users in assessing the social, epidemiological, behavioral, and environmental spheres of society for planning and evaluating programs. In summary, the aim of the study is to evaluate the effect of the Precede-Process Model-based simulation training program on preventing needlestick injuries in nurses who are the occupational group most exposed to injury.
- Conditions
- Needlestick Injuries
- Being tested
- Precede-Proceed Model Based Simulation Experience, Control Group
- Keywords
- Needlestick Injuries, Healthcare workers, Simulation, Precede-process model, Model based learning
- Medical subject headings
- Needlestick Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precede-Proceed Model Based Simulation ExperienceBehavioural
The program was created on the basis of the PRECEDE-PROCEED Model.The program consists of eight phases. It will be carried out with theoretical training and simulation experience in the experimental group. In the control group, theoretical training will be given. Results will be followed.
Control GroupBehavioural
No intervention in control group just theoretical education was done for them.
| Study group | Role | What they receive |
|---|---|---|
| Precede-Proceed Model Based Simulation Experience | Experimental | Not described Receives: Behavioral: Precede-Proceed Model Based Simulation Experience; Behavioral: Control Group |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Student Satisfaction and Self-Confidence in Learning Level
The Student Satisfaction and Self-Confidence in Learning Scale: This instrument is a 13 item scale used to measure student satisfaction with the simulation activity (5 items) and self-confidence in learning(8 items). Responses are rated on a 5-point Likert scale with values ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate higher satisfaction and greater levels of self-confidence.
Measured: Immediately after the simulation
Simulation Design Features Level
Simulation Design Scale: The Simulation Design Scale is a 20-item tool developed. Responses are rated on a 5 point Likert scale with the values ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate increased recognition of design features in simulation.
Measured: Immediately after the simulation
Recognition of Educational Best Practices in Simulation
Education Practice Questionnaire: The instrument has 16 items and includes the following elements: learning (10 items); diverse ways of learning (2 items); high expectations (2 items); and collaboration (2 items). The instrument uses a 5-point Likert scale with categories ranging from 1 (strongly disagree with the statement) to 5 (strongly agree with the statement). Higher scores indicate increased recognition of educational best practices in simulation.
Measured: Immediately after the simulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start1 Sep 2021
- Primary completion1 Jan 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Needlestick InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azize Karahan, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211999
- Sponsor's protocol ID
- 2019-19/26
- Status last verified
- Jan 2023
- First submitted
- 19 Dec 2021
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Precede-Proceed Model Based Simulation Experience in Needlestick and Sharps Injuries Among Nurses
- ClinicalTrials.gov ID
- NCT05211999
- Acronym / sponsor ID
- 2019-19/26
- Conditions
- Needlestick Injuries
- Keywords
- Needlestick Injuries, Healthcare workers, Simulation, Precede-process model, Model based learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Healthcare workers are exposed to many important risks that will negatively affect their health in their working environment. Among these risks, the most important threat is needlestick injuries. Needlestick injuries in healthcare workers with work-related injuries among studies, and the prevalence of injury remains high. In a study conducted by Gheshlagh et al. (2018), the prevalence of needlestick injuries in health workers was found to be 42.5%. It has been shown in studies conducted that the most common decision needlestick injuries among health workers are in nurses. In preventing injuries, preventing, and controlling negative behaviors related to the safe use of needlestick tools is among the most important strategies. In addition, the use of evidence obtained from interventional studies to prevent needlestick injuries in protection programs also plays an important role in prevention.
The importance of frequent and regular education about the subject has been mentioned especially in the studies conducted to prevent injuries. The World Health Organization (WHO) has published gold standards in the education of nurses and has recommended the use of electronic learning and simulation methods in the programs of nursing schools for learning and teaching according to these standards. It is important to use evidence-based practices to increase quality and competence by creating realistic clinical environments in nursing education. In this context, it is possible to use simulation-based experiences for educational purposes without exposure to infection control and employee safety in the clinical field.
In a study conducted by Nakamura et al. (2019), it was found that a simulation-based training program was effective in infection control. Due to the limited number of studies aimed at protecting the health of healthcare workers and controlling infection, more simulation-based studies are needed in this area. In addition, conducting model-based studies in developing behavior in health workers will also increase success. One of these models, the Precede-Process Model, is an important guide for users in assessing the social, epidemiological, behavioral, and environmental spheres of society for planning and evaluating programs. In summary, the aim of the study is to evaluate the effect of the Precede-Process Model-based simulation training program on preventing needlestick injuries in nurses who are the occupational group most exposed to injury.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Precede-Proceed Model Based Simulation Experience | Experimental | Behavioral: Precede-Proceed Model Based Simulation Experience, Behavioral: Control Group |
| Control Group | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 0-1 years of experience in the profession,
- Nurses who volunteered to participate in the study,
Key exclusion criteria (2 listed)
- Nurses who graduated from Acıbadem Mehmet Ali Aydınlar University
- Nurses who have worked in the profession for more than one year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Precede-Proceed Model Based Simulation ExperienceThe program was created on the basis of the PRECEDE-PROCEED Model.The program consists of eight phases. It will be carried out with theoretical training and simulation experience in the experimental group. In the control group, theoretical training will be given. Results will be followed. | Behavioural | Precede-Proceed Model Based Simulation Experience |
| Control GroupNo intervention in control group just theoretical education was done for them. | Behavioural | Precede-Proceed Model Based Simulation Experience |
Primary outcome
Student Satisfaction and Self-Confidence in Learning Level
Time frame: Immediately after the simulation
The Student Satisfaction and Self-Confidence in Learning Scale: This instrument is a 13 item scale used to measure student satisfaction with the simulation activity (5 items) and self-confidence in learning(8 items). Responses are rated on a 5-point Likert scale with values ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate higher satisfaction and greater levels of self-confidence.
Simulation Design Features Level
Time frame: Immediately after the simulation
Simulation Design Scale: The Simulation Design Scale is a 20-item tool developed. Responses are rated on a 5 point Likert scale with the values ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate increased recognition of design features in simulation.
Recognition of Educational Best Practices in Simulation
Time frame: Immediately after the simulation
Education Practice Questionnaire: The instrument has 16 items and includes the following elements: learning (10 items); diverse ways of learning (2 items); high expectations (2 items); and collaboration (2 items). The instrument uses a 5-point Likert scale with categories ranging from 1 (strongly disagree with the statement) to 5 (strongly agree with the statement). Higher scores indicate increased recognition of educational best practices in simulation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Precede-Proceed Model Based Simulation Experience in people with Needlestick Injuries, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Student Satisfaction and Self-Confidence in Learning Level (time frame: Immediately after the simulation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.