Clinical trial NCT06472401: Integrated Learning Support System Based on Immersive Simulated Training for Nursing Students
Official title: Integrated Learning Support System Based on Immersive Simulated Training for Nursing Students: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Simulation Training
Learning
Educational Technology
Nephrotoxicity
Physiological Stress
Lead sponsor: University of Brasilia
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to evaluate the effectiveness of an Integrated Learning Support System (ILSS) in preparing undergraduate nursing students for immersive simulated training in managing drug-induced nephrotoxicity. The study hypothesizes that the ILSS, which accommodates different learning styles, will be more effective in reducing stress and anxiety compared to the standard learning model (SLM). The research will involve a parallel randomized controlled trial with 96 students from two Brazilian institutions. The students will be divided into control and experimental groups, with the latter using the ILSS in addition to SLM during preparation. The study will assess outcomes such as knowledge acquisition, skill development, and stress reduction using various instruments, including the Lasater Clinical Judgment Rubric and DASS-21. The study's findings aim to validate the ILSS as a tool to enhance learning outcomes and reduce stress and anxiety, thereby promoting better professional development and patient safety in nursing practice.

Detailed description: Simulation has stood out at the forefront as one of the methods adopted to recreate the care process to make it safer. However, it is not clear whether the simulation attenuates or accentuates the levels of stress and anxiety. The standard learning model, as it does not contemplate different learning styles, may present deficiencies in the student's preparation for the simulated strategy, allowing negative effects, such as stress and anxiety, to easily appear. On the other hand, the adoption of an Integrated Learning Support System (ILSS), covering different learning styles, would be more effective, above all, to prevent or mitigate the possible negative effects of the simulated strategy, the theme defended in this proposal. The objective of this study is to evaluate the effectiveness of an ILSS applied during the preparation of undergraduate nursing students for immersive simulated training in the management of drug-induced nephrotoxicity. A parallel randomized controlled trial guided by the CONSORT recommendations extended to health simulation research will be conducted. Data collection will take place in two higher education institutions in the Federal District, Brazil, one public and one private, chosen for being a reference in teaching mediated by the simulation strategy. Study participants will be undergraduate nursing students. A sample size calculation resulted in the need for 96 students. The following instruments will be adopted: 1) Questionnaire to characterize the participants; 2) Questionnaire to assess theoretical knowledge; 3) Lasater Clinical Judgment Rubric, Brazilian version; 4) Checklist for evaluating practical performance; 5) Reduced version of the Depression, Anxiety and Stress Scale (DASS-21). In this study, a theoretical-practical course will be created and offered on the systematization of nursing care for patients with drug-induced nephrotoxicity. The syllabus of the course is divided into online and face-to-face modes. Students will be submitted in pairs to previously created and validated simulation scenarios. In the Control Group, students will be submitted to the Standard Learning Model (SLM) during the preparation stage for the immersive simulated training, consisting of: use of expository video lessons, participation in doubt forums, reading, and critical analysis of scientific articles. For the Experimental Group, in addition to the SLM, an ILSS composed of strategies to achieve different learning styles will be added. The study outcomes will be: acquisition of knowledge, skills, and attitudes towards the management of drug-induced nephrotoxicity; reduction of self-reported levels of stress. Categorical variables will be expressed in absolute and relative frequencies, and scalar and continuous numerical variables will be expressed in summary measures (mean and median) and dispersion (standard deviation and 25th and 75th percentiles). The normality of the variables will be verified by the Kolmogorov Smirnov test. The Chi-square, Mann-Whitney, and Fisher's exact tests will be adopted for correlations between groups and the Wilcoxon test for intragroup correlations, considering results with p values ≤ 0.05 as significant. The Integrated Learning Support System (ILSS) will be another tool available to nursing educators to promote environments conducive to professional development with a reduction of factors that negatively interfere with the learning process, such as anxiety and stress. In the long term, it is expected to stimulate the implementation of simulation as an active, educational, and permanent methodology for undergraduate nursing students, aiming at training professionals capable of promoting improvements in the quality of care practice and, consequently, patient safety.

Eligibility criteria: Inclusion Criteria:

* Be aged ≥ 18 years old;
* Students enrolled in the last two years of the undergraduate nursing course;
* Students who have self-declared internet access in their homes to complete the course's online modules.

Exclusion Criteria:

* Students who have previous training and/or professional experience in the health area;
* Students who do not complete at least 75% of the workload of the proposed course.

Primary outcomes:
measure: Knowledge about Prevention of Contrast-Induced Nephrotoxicity (baseline)
timeFrame: Evaluated one week before participation in the simulation scenario.
measure: Knowledge about Prevention of Contrast-Induced Nephrotoxicity (one week before simulation)
timeFrame: Evaluated Immediately after participation in the simulation scenario
measure: Knowledge about Prevention of Contrast-Induced Nephrotoxicity (thirty days after simulation)
timeFrame: Evaluated Thirty days after participation in the simulation scenario
Secondary outcomes:
measure: Practical Performance in Realistic Simulation
timeFrame: During the simulated scenario.
measure: Clinical Judgment on Prevention of Contrast-Induced Nephrotoxicity (baseline)
timeFrame: Evaluated one week before participation in the simulation scenario
measure: Clinical Judgment on Prevention of Contrast-Induced Nephrotoxicity (immediately after simulation)
timeFrame: Evaluated immediately after participation in the simulation scenario
measure: Clinical Judgment on Prevention of Contrast-Induced Nephrotoxicity (thirty days after simulation)
timeFrame: Evaluated thirty days after participation in the simulation scenario
measure: Depression, Anxiety and Stress (baseline)
timeFrame: Evaluated one week before participation in the simulation scenario
measure: Depression, Anxiety and Stress (immediately after simulation)
timeFrame: Evaluated immediately after participation in the simulation scenario
measure: Depression, Anxiety and Stress (thirty days after simulation)
timeFrame: Evaluated thirty days after participation in the simulation scenario
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: Care Skills and Simulation Laboratory
state: Federal District
Study officials:
affiliation: University of Brasilia
name: Marcia CS Magro, PhD
role: STUDY_DIRECTOR
affiliation: University of Brasilia
name: Breno S Santana, MsC
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Dreifuerst KT. Using debriefing for meaningful learning to foster development of clinical reasoning in simulation. J Nurs Educ. 2012 Jun;51(6):326-33. doi: 10.3928/01484834-20120409-02. Epub 2012 Apr 9.
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