Skip to content

Effectiveness of High Fidelity Simulation for Safety in the Medication Process in Intensive Care

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03828526
Enrollment
76
Registered
2019-02-04
Start date
2019-03-01
Completion date
2019-12-31
Last updated
2019-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Compliant Behavior, Learning Process in Nursing Graduation

Keywords

Patient Safety, Medication Errors, Critical Care, Nursing Education, High Fidelity Simulation Training

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.

Interventions

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

OTHERTraditional teaching strategy

Classroom-based strategy

Sponsors

University of Brasilia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Previous knowledge about the preparation and administration of intravenous drugs in intensive care (pre-test)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 (post-test)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 (1st retention)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).
Knowledge about the preparation and administration of intravenous drugs in intensive care (2nd retention)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).

Secondary

MeasureTime frameDescription
Student Satisfaction and Self-Confidence in LearningThe scale will be applied in two distinct times: Time 1 - before the intervention; Time 2 - immediately after the intervention.It will be measured through the application of the Student Satisfaction and Self-Confidence in Learning scale, composed of 13 items. Each item should be marked on a scale from 1 (worst score) to 5 (best score), where 1 - strongly disagree with the statement; 2 - I disagree with the statement; 3 - I do not agree or disagree; 4 - I agree with the statement; 5 - strongly agree with the statement.
Perceived gains from high fidelity simulationThe scale will be applied immediately after the intervention.It will be measured through the application of the High-fidelity simulation gains on nursing education scale, composed of 26 items related to the skills developed through the simulation strategy. Each item should be marked on a scale from 1 (worst score) to 5 (best score), where 1 - I get worse; 2 - remained the same; 3 - I have improved little; 4 - I have improved considerably; 5 - I have improved immensely.

Countries

Brazil

Contacts

Primary ContactMarcia CS Magro, PhD
marciamagro@unb.br5561982690888
Backup ContactBreno S Santana, Graduate
bresousas@outlook.com5561982085031

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026