NCT05211999

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2021

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

4 months

First QC Date

December 19, 2021

Last Update Submit

January 31, 2023

Conditions

Keywords

Needlestick InjuriesHealthcare workersSimulationPrecede-process modelModel based learning

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Immediately after the simulation

Study Arms (2)

Precede-Proceed Model Based Simulation Experience

EXPERIMENTAL
Behavioral: Precede-Proceed Model Based Simulation ExperienceBehavioral: Control Group

Control Group

NO INTERVENTION

Interventions

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.

Precede-Proceed Model Based Simulation Experience
Control GroupBEHAVIORAL

No intervention in control group just theoretical education was done for them.

Precede-Proceed Model Based Simulation Experience

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • years of experience in the profession,
  • Nurses who volunteered to participate in the study,

You may not qualify if:

  • Nurses who graduated from Acıbadem Mehmet Ali Aydınlar University
  • Nurses who have worked in the profession for more than one year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acibadem University

Istanbul, Eyalet/Yerleşke, 34360, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Needlestick Injuries

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Wounds, StabWounds, PenetratingWounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

December 19, 2021

First Posted

January 27, 2022

Study Start

September 1, 2021

Primary Completion

January 1, 2022

Study Completion

March 30, 2022

Last Updated

February 1, 2023

Record last verified: 2023-01

Locations