Integrated Learning Support System Based on Immersive Simulated Training for Nursing Students

NCT06472401 | Not Yet Recruiting

• 1 other identifier: 55509622.9.3001.5650
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Simulation Training; Learning; Educational Technology; Nephrotoxicity; Physiological Stress

Outcome Measures

Primary Outcomes (3)

• Knowledge about Prevention of Contrast-Induced Nephrotoxicity (baseline)

  Assessment of knowledge about prevention of contrast-induced nephrotoxicity using a standardized questionnaire. Unit of Measure: Percentage of correct responses

  Evaluated one week before participation in the simulation scenario.

• Knowledge about Prevention of Contrast-Induced Nephrotoxicity (one week before simulation)

  Assessment of knowledge about prevention of contrast-induced nephrotoxicity using a standardized questionnaire. Unit of Measure: Percentage of correct responses

  Evaluated Immediately after participation in the simulation scenario

• Knowledge about Prevention of Contrast-Induced Nephrotoxicity (thirty days after simulation)

  Assessment of knowledge about prevention of contrast-induced nephrotoxicity using a standardized questionnaire. Unit of Measure: Percentage of correct responses

  Evaluated Thirty days after participation in the simulation scenario

Secondary Outcomes (7)

• Practical Performance in Realistic Simulation

  During the simulated scenario.

• Clinical Judgment on Prevention of Contrast-Induced Nephrotoxicity (baseline)

  Evaluated one week before participation in the simulation scenario

• Clinical Judgment on Prevention of Contrast-Induced Nephrotoxicity (immediately after simulation)

  Evaluated immediately after participation in the simulation scenario

• Clinical Judgment on Prevention of Contrast-Induced Nephrotoxicity (thirty days after simulation)

  Evaluated thirty days after participation in the simulation scenario

• Depression, Anxiety and Stress (baseline)

  Evaluated one week before participation in the simulation scenario

Study Arms (2)

Integrated Learning Support System (ILSS)

EXPERIMENTAL

For the Experimental Group, in addition to the Standard Learning Model (MPA), an Integrated Learning Support System (ILSS) will be added, consisting of strategies to achieve different learning styles

Other: Integrated Learning Support System

Standard Learning Model (SLM)

ACTIVE COMPARATOR

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.

Other: Standard Learning Model

Interventions

Integrated Learning Support System OTHER

Students will receive simulation preparation with an Integrated Learning Support System consisting of: * Educational technology in comic book format * Virtual monitoring system with tutors * Psychological follow-up * Music listening and relaxation session

Integrated Learning Support System (ILSS)

Standard Learning Model OTHER

Students will receive standard simulation preparation consisting of: \- Expository and dialogued theoretical class.

Standard Learning Model (SLM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Brasilia: lead

Study Sites (1)

Care Skills and Simulation Laboratory

Brasília, Federal District, 72220-275, Brazil

Location

Related Publications (5)

• Salvarani V, Ardenghi S, Rampoldi G, Bani M, Cannata P, Ausili D, Di Mauro S, Strepparava MG. Predictors of psychological distress amongst nursing students: A multicenter cross-sectional study. Nurse Educ Pract. 2020 Mar;44:102758. doi: 10.1016/j.nepr.2020.102758. Epub 2020 Mar 13.

  PMID: 32234667 BACKGROUND

• Lasater K. Clinical judgment development: using simulation to create an assessment rubric. J Nurs Educ. 2007 Nov;46(11):496-503. doi: 10.3928/01484834-20071101-04.

  PMID: 18019107 BACKGROUND

• Grimes DA, Schulz KF. Bias and causal associations in observational research. Lancet. 2002 Jan 19;359(9302):248-52. doi: 10.1016/S0140-6736(02)07451-2.

  PMID: 11812579 BACKGROUND

• 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.

  PMID: 22495923 BACKGROUND

• Cheng A, Kessler D, Mackinnon R, Chang TP, Nadkarni VM, Hunt EA, Duval-Arnould J, Lin Y, Cook DA, Pusic M, Hui J, Moher D, Egger M, Auerbach M; International Network for Simulation-based Pediatric Innovation, Research, and Education (INSPIRE) Reporting Guidelines Investigators. Reporting guidelines for health care simulation research: extensions to the CONSORT and STROBE statements. Adv Simul (Lond). 2016 Jul 25;1:25. doi: 10.1186/s41077-016-0025-y. eCollection 2016.

  PMID: 29449994 BACKGROUND

Study Officials

• Marcia CS Magro, PhD

  University of Brasilia

  STUDY DIRECTOR

• Breno S Santana, MsC

  University of Brasilia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Breno S Santana, MsC

CONTACT

+5561982085031; bresousas@outlook.com

Alberto Augusto M Paiva, Nurse

CONTACT

+5561982085031; albertopaiva19@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study will adopt a double-blind approach. The exchange of information between the students who will compose the Experimental and Control groups is already expected, that is, the contamination effect, which causes a tendency to underestimate the true effect of the intervention. In this sense, throughout the duration of the simulated scenarios, a flow will be established in which each group (intervention and control) of students will be kept in different environments, to guarantee confinement, a condition that will prevent contact between the different groups. The main researcher will be blinded, that is, he will not have knowledge about the distribution of groups (randomization) and who will receive the Integrated Learning Support System (ILSS). The statistician responsible for data analysis will also be blinded, as he will receive and analyze coded data, without knowing the identity of the participants and the intervention allocated to each one.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: June 25, 2024
• Study Start: August 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)