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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05630391
Other study ID # Simcovid
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 15, 2022
Est. completion date August 25, 2022

Study information

Verified date November 2022
Source Sakarya University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date August 25, 2022
Est. primary completion date June 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 24 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Sakarya University Sakarya

Sponsors (1)

Lead Sponsor Collaborator
Sakarya University

Country where clinical trial is conducted

Turkey, 

References & Publications (24)

Ahorsu DK, Lin CY, Imani V, Saffari M, Griffiths MD, Pakpour AH. The Fear of COVID-19 Scale: Development and Initial Validation. Int J Ment Health Addict. 2022;20(3):1537-1545. doi: 10.1007/s11469-020-00270-8. Epub 2020 Mar 27. — View Citation

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. — View Citation

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. — View Citation

Bakioglu F, Korkmaz O, Ercan H. Fear of COVID-19 and Positivity: Mediating Role of Intolerance of Uncertainty, Depression, Anxiety, and Stress. Int J Ment Health Addict. 2021;19(6):2369-2382. doi: 10.1007/s11469-020-00331-y. Epub 2020 May 28. — View Citation

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. — View Citation

Bouchoucha SL, Phillips NM, Lucas J, Kilpatrick M, Hutchinson A. An investigation into nursing students' application of infection prevention and control precautions. Nurse Educ Today. 2021 Sep;104:104987. doi: 10.1016/j.nedt.2021.104987. Epub 2021 May 29. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Koukourikos K, Tsaloglidou A, Kourkouta L, Papathanasiou IV, Iliadis C, Fratzana A, Panagiotou A. Simulation in Clinical Nursing Education. Acta Inform Med. 2021 Mar;29(1):15-20. doi: 10.5455/aim.2021.29.15-20. — View Citation

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. — View Citation

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. Review. — View Citation

Medina Fernández IA, Carreño Moreno S, Chaparro Díaz L, Gallegos-Torres RM, Medina Fernández JA, Hernández Martínez EK. Fear, Stress, and Knowledge regarding COVID-19 in Nursing Students and Recent Graduates in Mexico. Invest Educ Enferm. 2021 Feb;39(1). doi: 10.17533/udea.iee.v39n1e05. — View Citation

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

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. Erratum in: J Med Internet Res. 2019 Jun 27;21(6):e14155. — View Citation

Pol-Castañeda 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. Erratum in: BMC Nurs. 2022 Jun 14;21(1):154. — View Citation

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. Erratum in: J Crit Care. 2021 Jun;63:280-281. — View Citation

Verbeek JH, Rajamaki B, Ijaz S, Sauni R, Toomey E, Blackwood B, Tikka C, Ruotsalainen JH, Kilinc Balci FS. Personal protective equipment for preventing highly infectious diseases due to exposure to contaminated body fluids in healthcare staff. Cochrane Database Syst Rev. 2020 Apr 15;4:CD011621. doi: 10.1002/14651858.CD011621.pub4. Update in: Cochrane Database Syst Rev. 2020 May 15;5:CD011621. — View Citation

Watson C, Gómez-Ibáñez R, Granel N, Bernabeu-Tamayo MD. Nursing students first experience on high fidelity simulation: A phenomenological research study. Nurse Educ Pract. 2021 Aug;55:103162. doi: 10.1016/j.nepr.2021.103162. Epub 2021 Jul 23. — View Citation

Yu M, Yang MR. Effectiveness and Utility of Virtual Reality Infection Control Simulation for Children With COVID-19: Quasi-Experimental Study. JMIR Serious Games. 2022 May 27;10(2):e36707. doi: 10.2196/36707. — View Citation

* Note: There are 24 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Establish fear of COVID-19 levels of nursing students 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 Bakioglu, 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 a = 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 (Satici 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; Bakioglu, Korkmaz, and Ercan 2021). Through study completion, an average of 1 month
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