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Clinical Trials/NCT03828526
NCT03828526
Unknown
Not Applicable

Effectiveness of High Fidelity Simulation for Safety in the Medication Process in Intensive Care: Randomized Clinical Trial

University of Brasilia1 site in 1 country76 target enrollmentMarch 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Learning Process in Nursing Graduation
Sponsor
University of Brasilia
Enrollment
76
Locations
1
Primary Endpoint
Knowledge about the preparation and administration of intravenous drugs in intensive care (post-test)
Last Updated
7 years ago

Overview

Brief Summary

Nursing plays an important role in the medication process in intensive care units. The application of active methodologies guided by the simulation strategy can help in the formation of qualified professionals and in the safer promotion of health care. The objectives to evaluate the effectiveness of the high fidelity simulation applied to nursing students in the process of administering drugs to critical patients in the intensive care setting; evaluate knowledge acquisition, satisfaction and self-confidence after the simulation. This is a prospective, single-blinded, controled clinical trial, with a quantitative approach. The sample will be composed of nursing students who are attending or have completed the discipline of critical care. The students will be randomized electronically to the experimental group, whose intervention will be guided by the high fidelity simulation method and, to the control group, the handling of static dummies / traditional teaching will be adopted as teaching strategy. Both strategies will emphasize the safety process during medication administration to critical patients hospitalized in the intensive care unit and will have an expository class dialogued prior to the intervention. Pre and post-tests will be applied at different times to evaluate the evolution of the level of knowledge and its retention and also, scales of satisfaction and self-confidence in learning. Descriptive and inferential statistics will be performed, as appropriate. It is believed that students submitted to simulation will have the opportunity to better consolidate knowledge during the training process, improve clinical and critical thinking, and decision-making, which will positively influence the safety of critically ill patients of the intensive care unit.

Detailed Description

Objective To evaluate the effectiveness of the high fidelity simulation for learning related to the drug preparation and administration process in the scenario of critical patient care in the cognitive, psychomotor and affective domains for undergraduate students of the nursing course. Hypothesis of the study Null hypothesis There will be no difference between learning through high fidelity simulation and traditional teaching / low fidelity simulation. Alternative hypothesis The high fidelity simulation strategy improves the performance of nursing students in drug administration more significantly when compared to traditional teaching / low fidelity simulation.

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
December 31, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Brasilia
Responsible Party
Principal Investigator
Principal Investigator

Marcia Cristina da Silva Magro

Principal Investigator

University of Brasilia

Eligibility Criteria

Inclusion Criteria

  • Students enrolled in the undergraduate nursing course of a public university in Brazil; Students coursing or who have completed critical care discipline.

Exclusion Criteria

  • Students with previous training in health.

Outcomes

Primary Outcomes

Knowledge about the preparation and administration of intravenous drugs in intensive care (post-test)

Time Frame: Questionnaire application immediately after the intervention (post-test)

It will be measured by applying a "Knowledge Questionnaire" consisting of 5 objective questions to study participants. The minimum score on the test will be 0 points (worst score) and the maximum score will be 100 points (best score).

Knowledge about the preparation and administration of intravenous drugs in intensive care (2nd retention)

Time Frame: Questionnaire application three months after intervention (1st retention)

It will be measured by applying a "Knowledge Questionnaire" consisting of 5 objective questions to study participants. The minimum score on the test will be 0 points (worst score) and the maximum score will be 100 points (best score).

Previous knowledge about the preparation and administration of intravenous drugs in intensive care (pre-test)

Time Frame: Questionnaire application prior to the intervention (pre-test)

It will be measured by applying a "Knowledge Questionnaire" consisting of 5 objective questions to study participants. The minimum score on the test will be 0 points (worst score) and the maximum score will be 100 points (best score).

Knowledge about the preparation and administration of intravenous drugs in intensive care (1st retention)

Time Frame: Questionnaire application one month after intervention (1st retention)

It will be measured by applying a "Knowledge Questionnaire" consisting of 5 objective questions to study participants. The minimum score on the test will be 0 points (worst score) and the maximum score will be 100 points (best score).

Secondary Outcomes

  • Student Satisfaction and Self-Confidence in Learning(The scale will be applied in two distinct times: Time 1 - before the intervention; Time 2 - immediately after the intervention.)
  • Perceived gains from high fidelity simulation(The scale will be applied immediately after the intervention.)

Study Sites (1)

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