Effectiveness of Simulation With Nursing Students in the Care of Patients With Sepsis

Effectiveness of Simulation in the Cognitive, Physiological and Emotional Sphere of Nursing Students in Caring for Patients With Signs of Sepsis: Crossover Clinical Trial

Simulation is an active teaching strategy capable of reproducing real situations and allowing practical experiences, in which the student is the protagonist of his own knowledge. Scientific evidence highlights, that exposure to the unknown or new can generate stress to the individual, but when dosed, to a certain extent it can increase the level of knowledge. Not infrequently, the lack of stress control can trigger physiological and subjective changes resulting from the increase in its level, such as situations that include the implementation of simulation scenarios in pedagogical teaching models.

Study Overview

• Status: Unknown
• Conditions: Stress; Learning Process in Nursing Graduation
• Intervention / Treatment: Other: High-Fidelity Simulation; Other: Low-Fidelity Simulation

Detailed Description

Objective:

To evaluate the effect of simulation (high and low fidelity) on the cognitive, physiological and emotional sphere of nursing students in caring for patients with signs of sepsis.

Hypothesis of the study:

Null hypothesis: Students undergoing high-fidelity simulation will show similar levels of stress, cognitive performance and retention of knowledge in relation to those who will perform low-fidelity simulation in patients with signs of sepsis.

Alternative hypothesis: The cognitive performance and stress will be higher in students who experience high fidelity simulation when compared to students who experience low fidelity simulation.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marcia CS Magro, PhD; Phone Number: 5561982690888; Email: marciamagro@unb.br
• Study Contact Backup: Name: Barbara S Rodrigues, Graduate; Phone Number: 5561982409357; Email: mio.barby@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Students approved in the discipline related to nursing care for adult and elderly patients;
• Aged over 18 years.

Exclusion Criteria:

• Who have experience in the health field (firefighters and nursing technicians, among others);
• Members of the Health Simulation League;
• Those who do not complete all stages of the research.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-Fidelity Simulation; First, students will go through an inverted class on sepsis. Then, they will be submitted to high-fidelity simulation scenarios to care for patients with sespe. After the scenario, the students' physiological parameters (blood pressure, heart rate, body temperature, respiratory rate and oxygen saturation) will be measured. After the scenario, students will go through a reflective debriefing session.	Other: High-Fidelity Simulation; Teaching strategy based on high-fidelity simulation, which simulates the reality of health care to promote meaningful learning.
Active Comparator: Low-Fidelity Simulation; First, students will go through an inverted class on sepsis. Then, they will be submitted to low-fidelity simulation scenarios to care for patients with sespe. After the scenario, the students' physiological parameters (blood pressure, heart rate, body temperature, respiratory rate and oxygen saturation) will be measured. After the scenario, students will go through a feedback session.	Other: Low-Fidelity Simulation; Teaching strategy based on low-fidelity simulation, which simulates the reality of health care using less technological and less interactive mannequins.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive Performance (Baseline)	Students' knowledge about nursing care in sepsis measured using a structured questionnaire with six multiple-choice questions	Applied before the intervention
Cognitive Performance (Post-test)	Students' knowledge about nursing care in sepsis measured using a structured questionnaire with six multiple-choice questions	Applied immediately after the intervention
Cognitive Performance (Retention)	Students' knowledge about nursing care in sepsis measured using a structured questionnaire with six multiple-choice questions	Applied thirty days after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Student stress (Baseline)	Assessment of students' stress intensity with pedagogical activities through the application of the Kezkak Stress Scale. This scale has 31 items of the Likert type of 4 points, being: 1 - Nothing stressful; 2 - A little stressful; 3 - Very stressful; 4 - Extremely stressful. The value 1 means less stress and 4 more stress.	Before the intervention
Student stress (Post-test)	Assessment of students' stress intensity with pedagogical activities through the application of the Kezkak Stress Scale. This scale has 31 items of the Likert type of 4 points, being: 1 - Nothing stressful; 2 - A little stressful; 3 - Very stressful; 4 - Extremely stressful. The value 1 means less stress and 4 more stress.	Immediately after the intervention

Collaborators and Investigators

• Sponsor: University of Brasilia
• Investigators: Principal Investigator: Marcia CS Magro, PhD, University of Brasilia

Publications and helpful links

General Publications

• Bingham AL, Sen S, Finn LA, Cawley MJ. Retention of advanced cardiac life support knowledge and skills following high-fidelity mannequin simulation training. Am J Pharm Educ. 2015 Feb 17;79(1):12. doi: 10.5688/ajpe79112.
• Boostel R, Felix JVC, Bortolato-Major C, Pedrolo E, Vayego SA, Mantovani MF. Stress of nursing students in clinical simulation: a randomized clinical trial. Rev Bras Enferm. 2018 May;71(3):967-974. doi: 10.1590/0034-7167-2017-0187. English, Portuguese.
• Kaneko RMU, Lopes MHBM. Realistic health care simulation scenario: what is relevant for its design? Rev Esc Enferm USP. 2019 May 30;53:e03453. doi: 10.1590/S1980-220X2018015703453. English, Portuguese.
• Machado FR, Assuncao MS, Cavalcanti AB, Japiassu AM, Azevedo LC, Oliveira MC. Getting a consensus: advantages and disadvantages of Sepsis 3 in the context of middle-income settings. Rev Bras Ter Intensiva. 2016 Oct-Dec;28(4):361-365. doi: 10.5935/0103-507X.20160068. No abstract available.
• Englert NC, McDermott D. Back to Fundamentals: Using High- and Low-Fidelity Simulation to Provide Reinforcement of Preventative Measures for Sepsis. Crit Care Nurs Q. 2016 Jan-Mar;39(1):14-23. doi: 10.1097/CNQ.0000000000000097.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): March 30, 2021
• Study Completion (Anticipated): August 31, 2021

Study Registration Dates

• First Submitted: August 2, 2020
• First Submitted That Met QC Criteria: August 10, 2020
• First Posted (Actual): August 13, 2020

Study Record Updates

• Last Update Posted (Actual): August 13, 2020
• Last Update Submitted That Met QC Criteria: August 10, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Stress, Psychological; Learning; Simulation; Simulation Training; Nursing, Education
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis
• Other Study ID Numbers: 3906816

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No