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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04512183
Other study ID # 3906816
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date August 31, 2021

Study information

Verified date August 2020
Source University of Brasilia
Contact Marcia CS Magro, PhD
Phone 5561982690888
Email marciamagro@unb.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date August 31, 2021
Est. primary completion date March 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
High-Fidelity Simulation
Teaching strategy based on high-fidelity simulation, which simulates the reality of health care to promote meaningful learning.
Low-Fidelity Simulation
Teaching strategy based on low-fidelity simulation, which simulates the reality of health care using less technological and less interactive mannequins.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Brasilia

References & Publications (5)

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. — View Citation

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. Portuguese, English. — View Citation

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. — View Citation

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. — View Citation

Machado FR, Assunção MS, Cavalcanti AB, Japiassú 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. Portuguese, English. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Cognitive Performance (Baseline) Students' knowledge about nursing care in sepsis measured using a structured questionnaire with six multiple-choice questions Applied before the intervention
Primary 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
Primary 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 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
Secondary 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
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