NCT05630391

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 29, 2022

Completed
Last Updated

November 29, 2022

Status Verified

November 1, 2022

Enrollment Period

1 month

First QC Date

October 17, 2022

Last Update Submit

November 21, 2022

Conditions

Keywords

COVID-19SimulationPersonal protective equipmentNurse

Outcome Measures

Primary Outcomes (2)

  • Assessing nursing students of skills in wearing-removing personal protective equipment

    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

    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 Outcomes (1)

  • Establish fear of COVID-19 levels of nursing students

    Through study completion, an average of 1 month

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

OTHER

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

Interventions

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.

Intervention

Training for 26 nursing students who constituted the control group performed personnel protective equipment (PPE) wearing-removal practice

Control

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Not volunteering to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University

Sakarya, 54050, Turkey (TĂ¼rkiye)

Location

Related Publications (24)

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    PMID: 34012208BACKGROUND
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  • Kuru Alici N, Ozturk Copur E. Anxiety and fear of COVID-19 among nursing students during the COVID-19 pandemic: A descriptive correlation study. Perspect Psychiatr Care. 2022 Jan;58(1):141-148. doi: 10.1111/ppc.12851. Epub 2021 May 20.

    PMID: 34018195BACKGROUND
  • Alsolais A, Alquwez N, Alotaibi KA, Alqarni AS, Almalki M, Alsolami F, Almazan J, Cruz JP. Risk perceptions, fear, depression, anxiety, stress and coping among Saudi nursing students during the COVID-19 pandemic. J Ment Health. 2021 Apr;30(2):194-201. doi: 10.1080/09638237.2021.1922636. Epub 2021 May 12.

    PMID: 33978543BACKGROUND
  • Apisarnthanarak A, Apisarnthanarak P, Siripraparat C, Saengaram P, Leeprechanon N, Weber DJ. Impact of anxiety and fear for COVID-19 toward infection control practices among Thai healthcare workers. Infect Control Hosp Epidemiol. 2020 Sep;41(9):1093-1094. doi: 10.1017/ice.2020.280. Epub 2020 Jun 8. No abstract available.

    PMID: 32507115BACKGROUND
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    PMID: 32837421BACKGROUND
  • Basak T, Unver V, Moss J, Watts P, Gaioso V. Beginning and advanced students' perceptions of the use of low- and high-fidelity mannequins in nursing simulation. Nurse Educ Today. 2016 Jan;36:37-43. doi: 10.1016/j.nedt.2015.07.020. Epub 2015 Jul 29.

    PMID: 26282193BACKGROUND
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    PMID: 34098422BACKGROUND
  • Campanati FLDS, Ribeiro LM, Silva ICRD, Hermann PRS, Brasil GDC, Carneiro KKG, Funghetto SS. Clinical simulation as a Nursing Fundamentals teaching method: a quasi-experimental study. Rev Bras Enferm. 2021 Oct 18;75(2):e20201155. doi: 10.1590/0034-7167-2020-1155. eCollection 2021. English, Portuguese.

    PMID: 34669900BACKGROUND
  • Cheng A, Kessler D, Mackinnon R, Chang TP, Nadkarni VM, Hunt EA, Duval-Arnould J, Lin Y, Cook DA, Pusic M, Hui J, Moher D, Egger M, Auerbach M; International Network for Simulation-based Pediatric Innovation, Research, and Education (INSPIRE) Reporting Guidelines Investigators. Reporting guidelines for health care simulation research: extensions to the CONSORT and STROBE statements. Adv Simul (Lond). 2016 Jul 25;1:25. doi: 10.1186/s41077-016-0025-y. eCollection 2016.

    PMID: 29449994BACKGROUND
  • Driscoll B, Evans D. Nursing Infection Control Practice Adherence, Related Barriers, and Methods of Intervention. J Nurs Adm. 2022 Mar 1;52(3):132-137. doi: 10.1097/NNA.0000000000001120.

    PMID: 35170577BACKGROUND
  • Elo S, Kyngas H. The qualitative content analysis process. J Adv Nurs. 2008 Apr;62(1):107-15. doi: 10.1111/j.1365-2648.2007.04569.x.

    PMID: 18352969BACKGROUND
  • Eyikara E, Baykara ZG. Effect of simulation on the ability of first year nursing students to learn vital signs. Nurse Educ Today. 2018 Jan;60:101-106. doi: 10.1016/j.nedt.2017.09.023. Epub 2017 Oct 13.

    PMID: 29078202BACKGROUND
  • Fawaz MA, Hamdan-Mansour AM. Impact of high-fidelity simulation on the development of clinical judgment and motivation among Lebanese nursing students. Nurse Educ Today. 2016 Nov;46:36-42. doi: 10.1016/j.nedt.2016.08.026. Epub 2016 Aug 25.

    PMID: 27591378BACKGROUND
  • Graneheim UH, Lundman B. Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse Educ Today. 2004 Feb;24(2):105-12. doi: 10.1016/j.nedt.2003.10.001.

    PMID: 14769454BACKGROUND
  • Lei YY, Zhu L, Sa YTR, Cui XS. Effects of high-fidelity simulation teaching on nursing students' knowledge, professional skills and clinical ability: A meta-analysis and systematic review. Nurse Educ Pract. 2022 Mar;60:103306. doi: 10.1016/j.nepr.2022.103306. Epub 2022 Feb 2.

    PMID: 35202957BACKGROUND
  • Medina Fernandez IA, Carreno Moreno S, Chaparro Diaz L, Gallegos-Torres RM, Medina Fernandez JA, Hernandez Martinez EK. Fear, Stress, and Knowledge regarding COVID-19 in Nursing Students and Recent Graduates in Mexico. Invest Educ Enferm. 2021 Feb;39(1):e05. doi: 10.17533/udea.iee.v39n1e05.

    PMID: 33687809BACKGROUND
  • Najjar RH, Lyman B, Miehl N. Nursing students' experiences with high-fidelity simulation. Int J Nurs Educ Scholarsh. 2015 Mar 19;12:/j/ijnes.2015.12.issue-1/ijnes-2015-0010/ijnes-2015-0010.xml. doi: 10.1515/ijnes-2015-0010.

    PMID: 25803087BACKGROUND
  • Padilha JM, Machado PP, Ribeiro A, Ramos J, Costa P. Clinical Virtual Simulation in Nursing Education: Randomized Controlled Trial. J Med Internet Res. 2019 Mar 18;21(3):e11529. doi: 10.2196/11529.

    PMID: 30882355BACKGROUND
  • Pol-Castaneda S, Carrero-Planells A, Moreno-Mulet C. Use of simulation to improve nursing students' medication administration competence: a mixed-method study. BMC Nurs. 2022 May 16;21(1):117. doi: 10.1186/s12912-022-00897-z.

    PMID: 35578199BACKGROUND
  • Tabah A, Ramanan M, Laupland KB, Buetti N, Cortegiani A, Mellinghoff J, Conway Morris A, Camporota L, Zappella N, Elhadi M, Povoa P, Amrein K, Vidal G, Derde L, Bassetti M, Francois G, Ssi Yan Kai N, De Waele JJ; PPE-SAFE contributors. Personal protective equipment and intensive care unit healthcare worker safety in the COVID-19 era (PPE-SAFE): An international survey. J Crit Care. 2020 Oct;59:70-75. doi: 10.1016/j.jcrc.2020.06.005. Epub 2020 Jun 13.

    PMID: 32570052BACKGROUND
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    PMID: 32293717BACKGROUND
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    PMID: 34332280BACKGROUND
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    PMID: 35575818BACKGROUND

Related Links

MeSH Terms

Conditions

Personal SatisfactionCOVID-19

Interventions

Educational Status

Condition Hierarchy (Ancestors)

BehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 17, 2022

First Posted

November 29, 2022

Study Start

May 15, 2022

Primary Completion

June 15, 2022

Study Completion

August 25, 2022

Last Updated

November 29, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

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

Locations