Simulation of Physical IllnessNCT05630391
High-Fidelity Simulation Training: A Mixed Method Study
A study testing High-Fidelity Simulation Manikin and Education in people with Simulation of Physical Illness and Satisfaction, run by Sakarya University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Simulation of Physical Illness, Satisfaction
- What is being tested?
- High-Fidelity Simulation Manikin and Education
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2022to 25 Aug 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 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Not meeting the inclusion criteria
- Not volunteering to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Simulation of Physical Illness, Satisfaction
- Being tested
- High-Fidelity Simulation Manikin, Education
- Keywords
- COVID-19, Simulation, Personal protective equipment, Nurse
- Medical subject headings
- Personal Satisfaction, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Fidelity Simulation ManikinDevice
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.
EducationOther
Training for 26 nursing students who constituted the control group performed personnel protective equipment (PPE) wearing-removal practice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)".
Measured: 1 month
Secondary outcomes (1)
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 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).
Measured: Through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start15 May 2022
- Primary completion15 Jun 2022
- Study completion25 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Simulation of Physical IllnessStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, özlem doğu, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630391
- Sponsor's protocol ID
- Simcovid
- Status last verified
- Nov 2022
- First submitted
- 17 Oct 2022
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Planning to make a manuscript for this study and sharing participant identification information and outcomes.
Publications
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.
PubMed 34012208Ahorsu 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.
PubMed 32226353Kuru 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.
PubMed 34018195Alsolais 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.
PubMed 33978543Apisarnthanarak 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.
PubMed 32507115Bakioglu 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.
PubMed 32837421Basak 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.
PubMed 26282193Bouchoucha 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.
PubMed 34098422Campanati 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.
PubMed 34669900Cheng 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.
PubMed 29449994Driscoll 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.
PubMed 35170577Elo 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.
PubMed 18352969Eyikara 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.
PubMed 29078202Fawaz 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.
PubMed 27591378Graneheim 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.
PubMed 14769454
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Approach to the Coronavirus With Patient With High-Fidelity Simulation Training: A Mixed Method Study
- ClinicalTrials.gov ID
- NCT05630391
- Acronym / sponsor ID
- Simcovid
- Conditions
- Simulation of Physical Illness, Satisfaction
- Keywords
- COVID-19, Simulation, Personal protective equipment, Nurse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 15 May 2022 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 25 Aug 2022 (actual)
- First posted
- 29 Nov 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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: High-Fidelity Simulation ManikinIn 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. |
| Control | Other | Other: EducationThe 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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Not meeting the inclusion criteria
- Not volunteering to participate in the study
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 |
|---|---|---|
| High-Fidelity Simulation ManikinA 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. | Device | Intervention |
| EducationTraining for 26 nursing students who constituted the control group performed personnel protective equipment (PPE) wearing-removal practice | Other | Control |
Primary outcome
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.
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 secondary outcome
Establish fear of COVID-19 levels of nursing students
Time frame: Through study completion, an average of 1 month
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 29 Nov 2022.
- Background: PubMed 34012208Koukourikos 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.
- Background: PubMed 32226353Ahorsu 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.
- Background: PubMed 34018195Kuru 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.
- Background: PubMed 33978543Alsolais 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.
- Background: PubMed 32507115Apisarnthanarak 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.
- Background: PubMed 32837421Bakioglu 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.
- Background: PubMed 26282193Basak 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.
- Background: PubMed 34098422Bouchoucha 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.
- Background: PubMed 34669900Campanati 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.
- Background: PubMed 29449994Cheng 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.
- Background: PubMed 35170577Driscoll 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.
- Background: PubMed 18352969Elo 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.
- ReferenceLink provided by the sponsor.
- ReferenceLink provided by the sponsor.
- ReferenceLink provided by the sponsor.
- Individual participant dataSharing planned: No. Planning to make a manuscript for this study and sharing participant identification information and outcomes.
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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 High-Fidelity Simulation Manikin and Education in people with Simulation of Physical Illness and Satisfaction, run by Sakarya 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 4 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 29 Nov 2022. 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?
Assessing nursing students of skills in wearing-removing personal protective equipment (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05630391, which also lists 24 linked publications.
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 29 Nov 2022.