COVID-19 PandemicNCT05576636
COVID-19 Simulation Education on Nursing Students
A study testing Simulation training in people with COVID-19 Pandemic and Simulation of Physical Illness, run by Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to determine the effect of simulation education as an approach to patients with COVID-19 on nursing students' perception and fear of the COVID-19 disease. This study was conducted in a randomized controlled trials with 86 nursing students from a university between November 10 and December 10, 2021. Read more about this study
- Who is it for?
- Ages Up to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pandemic, Simulation of Physical Illness
- What is being tested?
- Simulation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Nov 2021to 10 Sep 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 Up to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Nursing student and
- Agreeing to participate in the study
Who cannot join
- Refusing to participate in the study or quitting the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Burdur Mehmet Akif Ersoy University
Burdur, 15000
About this study
Official title: The Effect of Simulation Education as an Approach to Patients With COVID-19 on Nursing Students' Perception and Fear of COVID-19 Disease: A Randomized Controlled Trial
This study aims to determine the effect of simulation education as an approach to patients with COVID-19 on nursing students' perception and fear of the COVID-19 disease. This study was conducted in a randomized controlled trials with 86 nursing students from a university between November 10 and December 10, 2021.
- Conditions
- COVID-19 Pandemic, Simulation of Physical Illness
- Being tested
- Simulation training, Control Group
- Keywords
- nursing student, perception of illness, fear of death.
- Medical subject headings
- COVID-19, Necrophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation trainingBehavioural
Expectations regarding the scenario were explained to the participants before the implementation. They were given information about the standard patient. Roles were distributed, and the implementation time of the scenario was announced. Written permission was obtained from students involved in the scenario. The intervention group was given scenario-based education appropriate for the approach to a standard patient with COVID-19. During the implementation of the scenario, the instructor did not interfere with students, and after the feedback, the "show-do" method was used to improve the incorrect skill steps. Two instructors evaluated students' performance on the standard patient simulation as "achieved-failed" and the application was recorded as a pre-test.
Control GroupOther
The control group didn't apply any interference during the study. Participants in the control group continued their routine follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | After the pre-tests (the COVID-19 Disease Perception Scale, and the Fear of COVID-19 Scale) , the students were given simulation education for one months. Receives: Behavioral: Simulation training |
| Control Group | Experimental | The control group didn't apply any interference during the study. Participants in the control group continued their routine follow-up. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Approach to COVID-19 Patient Form
This form was created by the researchers following a review of the literature (Collado-Boira et al., 2020; Cervera-Gasch, Gonz ́alez-Chorda ́, \& Mena-Tudela, 2020; Kurt, \& Dalkıran, 2021; Ulenaers, et al., 2021; Işık, Konuş, \& Bakar, 2021) and was evaluated by 3 experts who had a PhD degree in the field, and necessary improvements were made in line with their suggestions. It consists of 14 items in total. This form includes interventions, such as "The mask should be worn before entering the patient room or care area" and "Disposable respiratory and face masks should be removed and discarded after leaving the patient's room or care area and closing the door." The correct application of these interventions was scored with "1 point" and the incorrect application with "0 points". Scores range between 0 and 14. As the scores increase, the accuracy level of the approach to the patient increases, as well.
Measured: 5 Minute
The Fear of COVID-19 Scale
This scale was developed by Ahorsu et al. (2022), and its Turkish adaptation, validity, and reliability studies were performed by Ladikli et al. (2020). The scale has a single factor structure and consists of seven 5-point Likert-type (1 = strongly disagree; 5 = strongly agree) items. Scores on the scale range between 7 and 35. The higher the score is, the higher the fear of the COVID-19 pandemic is. Cronbach's alpha value of the scale is 0.82 (Ladikli et al., 2020).
Measured: 5 Minute
The COVID-19 Disease Perception Scale
This scale was developed by Geniş et al. (2020). It consists of seven items. It has a five-point Likert-type structure and consists of two sub-dimensions. The total score is calculated by summing the scores of the items on the sub-dimension and dividing the results by the number of items on that sub-dimension. This operation yields a value between 1 and 5. High scores on the dangerousness sub-dimension indicate that the perceived dangerousness of the disease is high, and high scores on the contagiousness sub-dimension indicate that the perceived contagiousness of the disease is high. Cronbach's alpha value of the original scale is 0.78 (Geniş et al., 2020).
Measured: 5 Minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start10 Nov 2021
- Primary completion10 Dec 2021
- Study completion10 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PandemicStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mehmet Akif Ersoy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurten Terkes, Mehmet Akif Ersoy University
- Investigators
- Sibel Senturk, PhD, Study chair, Burdur Mehmet Akif Ersoy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576636
- Sponsor's protocol ID
- MAKU-GO 2021/357
- Status last verified
- Jul 2023
- First submitted
- 7 Oct 2022
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All authors contributed to the interpretation, writing, and approval of the final manuscript.
Publications
Hung CC, Kao HS, Liu HC, Liang HF, Chu TP, Lee BO. Effects of simulation-based learning on nursing students' perceived competence, self-efficacy, and learning satisfaction: A repeat measurement method. Nurse Educ Today. 2021 Feb;97:104725. doi: 10.1016/j.nedt.2020.104725. Epub 2020 Dec 16.
PubMed 33373813Huang CL. [Impact of Nurse Practitioners and Nursing Education on COVID-19 Pandemics: Innovative Strategies of Authentic Technology-Integrated Clinical Simulation]. Hu Li Za Zhi. 2021 Oct;68(5):4-6. doi: 10.6224/JN.202110_68(5).01. Chinese.
PubMed 34549401Almomani E, Sullivan J, Hajjieh M, Leighton K. Simulation-based education programme for upskilling non-critical care nurses for COVID-19 deployment. BMJ Simul Technol Enhanc Learn. 2020 Oct 21;7(5):319-322. doi: 10.1136/bmjstel-2020-000711. eCollection 2021.
PubMed 35515720
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Simulation Education as an Approach to Patients With COVID-19 on Nursing Students' Perception and Fear of COVID-19 Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05576636
- Acronym / sponsor ID
- MAKU-GO 2021/357
- Conditions
- COVID-19 Pandemic, Simulation of Physical Illness
- Keywords
- nursing student, perception of illness, fear of death.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 10 Sep 2022 (actual)
- First posted
- 12 Oct 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.
This study aims to determine the effect of simulation education as an approach to patients with COVID-19 on nursing students' perception and fear of the COVID-19 disease. This study was conducted in a randomized controlled trials with 86 nursing students from a university between November 10 and December 10, 2021.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Simulation trainingAfter the pre-tests (the COVID-19 Disease Perception Scale, and the Fear of COVID-19 Scale) , the students were given simulation education for one months. |
| Control Group | Experimental | Other: Control GroupThe control group didn't apply any interference during the study. Participants in the control group continued their routine follow-up. |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Nursing student and
- Agreeing to participate in the study
Key exclusion criteria (1 listed)
- Refusing to participate in the study or quitting 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 |
|---|---|---|
| Simulation trainingExpectations regarding the scenario were explained to the participants before the implementation. They were given information about the standard patient. Roles were distributed, and the implementation time of the scenario was announced. Written permission was obtained from students involved in the scenario. The intervention group was given scenario-based education appropriate for the approach to a standard patient with COVID-19. During the implementation of the scenario, the instructor did not interfere with students, and after the feedback, the "show-do" method was used to improve the incorrect skill steps. Two instructors evaluated students' performance on the standard patient simulation as "achieved-failed" and the application was recorded as a pre-test. | Behavioural | Intervention group |
| Control GroupThe control group didn't apply any interference during the study. Participants in the control group continued their routine follow-up. | Other | Control Group |
Primary outcome
Approach to COVID-19 Patient Form
Time frame: 5 Minute
This form was created by the researchers following a review of the literature (Collado-Boira et al., 2020; Cervera-Gasch, Gonz ́alez-Chorda ́, \& Mena-Tudela, 2020; Kurt, \& Dalkıran, 2021; Ulenaers, et al., 2021; Işık, Konuş, \& Bakar, 2021) and was evaluated by 3 experts who had a PhD degree in the field, and necessary improvements were made in line with their suggestions. It consists of 14 items in total. This form includes interventions, such as "The mask should be worn before entering the patient room or care area" and "Disposable respiratory and face masks should be removed and discarded after leaving the patient's room or care area and closing the door." The correct application of these interventions was scored with "1 point" and the incorrect application with "0 points". Scores range between 0 and 14. As the scores increase, the accuracy level of the approach to the patient increases, as well.
The Fear of COVID-19 Scale
Time frame: 5 Minute
This scale was developed by Ahorsu et al. (2022), and its Turkish adaptation, validity, and reliability studies were performed by Ladikli et al. (2020). The scale has a single factor structure and consists of seven 5-point Likert-type (1 = strongly disagree; 5 = strongly agree) items. Scores on the scale range between 7 and 35. The higher the score is, the higher the fear of the COVID-19 pandemic is. Cronbach's alpha value of the scale is 0.82 (Ladikli et al., 2020).
The COVID-19 Disease Perception Scale
Time frame: 5 Minute
This scale was developed by Geniş et al. (2020). It consists of seven items. It has a five-point Likert-type structure and consists of two sub-dimensions. The total score is calculated by summing the scores of the items on the sub-dimension and dividing the results by the number of items on that sub-dimension. This operation yields a value between 1 and 5. High scores on the dangerousness sub-dimension indicate that the perceived dangerousness of the disease is high, and high scores on the contagiousness sub-dimension indicate that the perceived contagiousness of the disease is high. Cronbach's alpha value of the original scale is 0.78 (Geniş et al., 2020).
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 11 Jul 2023.
- Results publication: PubMed 33373813Hung CC, Kao HS, Liu HC, Liang HF, Chu TP, Lee BO. Effects of simulation-based learning on nursing students' perceived competence, self-efficacy, and learning satisfaction: A repeat measurement method. Nurse Educ Today. 2021 Feb;97:104725. doi: 10.1016/j.nedt.2020.104725. Epub 2020 Dec 16.
- Results publication: PubMed 34549401Huang CL. [Impact of Nurse Practitioners and Nursing Education on COVID-19 Pandemics: Innovative Strategies of Authentic Technology-Integrated Clinical Simulation]. Hu Li Za Zhi. 2021 Oct;68(5):4-6. doi: 10.6224/JN.202110_68(5).01. Chinese.
- Results publication: PubMed 35515720Almomani E, Sullivan J, Hajjieh M, Leighton K. Simulation-based education programme for upskilling non-critical care nurses for COVID-19 deployment. BMJ Simul Technol Enhanc Learn. 2020 Oct 21;7(5):319-322. doi: 10.1136/bmjstel-2020-000711. eCollection 2021.
- Individual participant dataSharing planned: No. All authors contributed to the interpretation, writing, and approval of the final manuscript.
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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.
Sibel Senturk, PhD study chair
Burdur Mehmet Akif Ersoy University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation training in people with COVID-19 Pandemic and Simulation of Physical Illness, run by Mehmet Akif Ersoy 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 2 inclusion and 1 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 11 Jul 2023. 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?
Approach to COVID-19 Patient Form (time frame: 5 Minute). The study lists 3 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 NCT05576636, which also lists 3 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 11 Jul 2023.