High-Fidelity Simulation Training: A Mixed Method Study

November 21, 2022 updated by: özlem doğu, Sakarya University

Approach to the Coronavirus With Patient With High-Fidelity Simulation Training: A Mixed Method Study

The goal of this clinical trial is to compare in describe first-year nursing students' skills. The main questions it aims to answer are:

  • Are nursing students who perform the simulation practice with the scenario-based high-fidelity simulation manikin higher than those who perform the practice with the standard demonstration method?
  • Are the satisfaction levels of nursing students who perform the simulation practice with the scenario-based high-fidelity simulation manikin higher than those who perform the practice with the standard demonstration method? Researchers will compare two groups of nursing students training with high-fidelity simulation manikin and training with standard demonstration method.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Sakarya, Turkey, 54050
        • Sakarya University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 24 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • First-year nursing students
  • Not have been trained in simulation before
  • Taking a nursing fundamentals course for the first time
  • Open to communication and volunteering to be involved in the study

Exclusion Criteria:

  • Not meeting the inclusion criteria
  • Not volunteering to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
In the process of teaching personnel protective equipment (PPE) use with the scenario-based high-fidelity simulation mannikin, a simulation application was made with 26 students. The simulation scenario was implemented with 13 groups consisting of 3 students each playing different roles (nurse, head nurse, patient relative). Throughout the scenario, the students who played the role of the nurse and the head nurse simulated the PPE wearing-removal practice in a way to cover all steps of the process (preparation, implementation, and evaluation). During the implementation of the scenario, the student playing the role of the patient's relative provided guiding clues to the nurse when needed. Debriefing was started right after the simulation. Frequency of administration the implementation of each group is once and the debriefing stage where the learning process was reinforced and lasted 30 minutes.
Device: High-Fidelity Simulation Manikin
A high-fidelity simulator was developed to teach skills in nursing education, and it is sized to represent an adult male patient. The mannequin can be controlled using a computer program, it can breathe, and its vital signs can be monitored using a bedside monitor.
Other: Control
The 26 students who constituted the control group performed the personnel protective equipment (PPE) wearing-removal practice once under the supervision of the researcher at the Fundamentals of Nursing skills laboratory. Frequency of administration the implementation of each group is once. The students applied experiential learning principles through active experience and reflective observation.
Other: Education
Training for 26 nursing students who constituted the control group performed personnel protective equipment (PPE) wearing-removal practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing nursing students of skills in wearing-removing personal protective equipment
Time Frame: 1 month
Procedural Steps Checklist was used to assess nursing wearing-removing skills. The checklist for PPE wearing-removal skills was created by the researchers based on their review of the relevant literature (Göçmen Baykara et al. 2020; Patricia Potter et al. 2020; World Health Organization 2021). Opinions were received from five faculty members with expertise in Fundamentals of Nursing for the checklist, and Kendall's W coefficient for the checklist was found as 0.776 (p < .001). The Cronbach's alpha coefficient of the checklist was calculated as 0.64, which showed a moderate level of internal consistency. The checklist to be used for assessment was finalized, and it consisted of 17 items. Each item was scored as 0 or 1, and the minimum and maximum total scores of the checklist were 0 and 17. When the participant performed the procedural step, they received 1 point for the related item, while they received 0 points when they failed to perform the step.
1 month
Describing nursing students of satisfaction levels
Time Frame: 1 month
VAS was used to determine which model was more satisfactory to nursing students. VAS was used to measure the satisfaction levels of the participants based on their own assessment between "0 (not satisfied at all) and 10 (very satisfied)".
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Establish fear of COVID-19 levels of nursing students
Time Frame: Through study completion, an average of 1 month
Fear of COVID-19 Scale (FCV-19S) was used to determine the COVID-19 fear levels of nursing students. This scale, which was developed by Ahorsu et al. (2020), was adapted to Turkish culture by Bakioğlu, Korkmaz, and Ercan (2020). It is a unidimensional scale consisting of seven items. The item-total correlation coefficients of the scale were reported to vary from 0.47 to 0.56, while its factor loads were reported to vary from 0.66 to 0.74. The Cronbach's alpha coefficient of the scale was reported as α = 0.82. A set of validity and reliability analyses was carried out for the five-point Likert-type scale in its Turkish adaptation study. The authors conducting the study reported Cronbach's alpha coefficient of the scale as 0.88. Other authors also adapted the scale to Turkish (Satıcı et al. 2020). Considering the results of adaptation studies, it may be stated that it is a valid and reliable scale (Ahorsu et al. 2022; Bakioğlu, Korkmaz, and Ercan 2021).
Through study completion, an average of 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sakarya University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2022

Primary Completion (Actual)

June 15, 2022

Study Completion (Actual)

August 25, 2022

Study Registration Dates

First Submitted

October 17, 2022

First Submitted That Met QC Criteria

November 21, 2022

First Posted (Actual)

November 29, 2022

Study Record Updates

Last Update Posted (Actual)

November 29, 2022

Last Update Submitted That Met QC Criteria

November 21, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Simcovid

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Planning to make a manuscript for this study and sharing participant identification information and outcomes.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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