NCT05576636

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

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

November 10, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2022

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2022

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

1 month

First QC Date

October 7, 2022

Last Update Submit

July 10, 2023

Conditions

Keywords

nursing studentperception of illnessfear of death.

Outcome Measures

Primary Outcomes (3)

  • 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.

    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).

    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).

    5 Minute

Study Arms (2)

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.

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.

Other: Control Group

Interventions

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.

Intervention group

The control group didn't apply any interference during the study. Participants in the control group continued their routine follow-up.

Control Group

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Nursing student and
  • Agreeing to participate in the study

You may not qualify if:

  • Refusing to participate in the study or quitting the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Burdur Mehmet Akif Ersoy University

Burdur, 15000, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

  • Huang 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.

  • Almomani 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.

MeSH Terms

Conditions

COVID-19Necrophobia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Sibel Senturk, PhD

    Burdur Mehmet Akif Ersoy University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
They did not know if they were in the control and intervention group at the time of randomization.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 7, 2022

First Posted

October 12, 2022

Study Start

November 10, 2021

Primary Completion

December 10, 2021

Study Completion

September 10, 2022

Last Updated

July 11, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

All authors contributed to the interpretation, writing, and approval of the final manuscript.

Locations