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

NCT ID: NCT06472401

Last Updated: 2024-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Simulation Training Learning Educational Technology Nephrotoxicity Physiological Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

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Integrated Learning Support System (ILSS)

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

Group Type EXPERIMENTAL

Integrated Learning Support System

Intervention Type 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

Standard Learning Model (SLM)

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.

Group Type ACTIVE_COMPARATOR

Standard Learning Model

Intervention Type OTHER

Students will receive standard simulation preparation consisting of:

\- Expository and dialogued theoretical class.

Interventions

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Integrated Learning Support System

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

Intervention Type OTHER

Standard Learning Model

Students will receive standard simulation preparation consisting of:

\- Expository and dialogued theoretical class.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Brasilia

OTHER

Sponsor Role lead

Responsible Party

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Marcia Cristina da Silva Magro

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marcia CS Magro, PhD

Role: STUDY_DIRECTOR

University of Brasilia

Breno S Santana, MsC

Role: PRINCIPAL_INVESTIGATOR

University of Brasilia

Locations

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Care Skills and Simulation Laboratory

Brasília, Federal District, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Breno S Santana, MsC

Role: CONTACT

+5561982085031

Alberto Augusto M Paiva, Nurse

Role: CONTACT

+5561982085031

Facility Contacts

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Marcia Cristina S Magro, PhD

Role: primary

+5561982690888

References

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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.

Reference Type BACKGROUND
PMID: 32234667 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18019107 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11812579 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22495923 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29449994 (View on PubMed)

Other Identifiers

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55509622.9.3001.5650

Identifier Type: -

Identifier Source: org_study_id

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