NCT04512183

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Status
unknown

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

First Submitted

Initial submission to the registry

August 2, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 13, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

August 13, 2020

Status Verified

August 1, 2020

Enrollment Period

7 months

First QC Date

August 2, 2020

Last Update Submit

August 10, 2020

Conditions

Keywords

SimulationStress, PsychologicalNursing, EducationSimulation TrainingLearning

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Student stress (Baseline)

    Before the intervention

  • Student stress (Post-test)

    Immediately after the intervention

Study Arms (2)

High-Fidelity Simulation

EXPERIMENTAL

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

Low-Fidelity Simulation

ACTIVE COMPARATOR

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

Interventions

Teaching strategy based on high-fidelity simulation, which simulates the reality of health care to promote meaningful learning.

High-Fidelity Simulation

Teaching strategy based on low-fidelity simulation, which simulates the reality of health care using less technological and less interactive mannequins.

Low-Fidelity Simulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 29924167BACKGROUND
  • 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.

    PMID: 31166535BACKGROUND
  • 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.

    PMID: 25741028BACKGROUND
  • 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.

    PMID: 28099632BACKGROUND
  • 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.

    PMID: 26633154BACKGROUND

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Marcia CS Magro, PhD

    University of Brasilia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcia CS Magro, PhD

CONTACT

Barbara S Rodrigues, Graduate

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator; PhD

Study Record Dates

First Submitted

August 2, 2020

First Posted

August 13, 2020

Study Start

September 1, 2020

Primary Completion

March 30, 2021

Study Completion

August 31, 2021

Last Updated

August 13, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share