- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04940455
Effect of Realistic Simulation and Digital Educational Platforms for Learning Nursing Student
Effect of Realistic Simulation and Digital Educational Platforms for Learning Nursing Student: Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marcia CS Magro, PhD
- Phone Number: 5561982690888
- Email: marciamagro@unb.br
Study Contact Backup
- Name: JANE WS NOGUEIRA, Master
- Phone Number: 5561999666669
- Email: janewalkiria@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Aged over 18 years;
Students approved in the discipline related to nursing care for adult and elderly patients.
Exclusion Criteria:
Students who actively work in the scenario of patient care in critical and risk situations; Members of the Realistic Health Simulation League; Students with previous training in the health area (nursing technicians, firefighters, among others) ; Participants who for some reason are absent from one of the project stages.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Educational digital platforms
Nursing students from the Experimental Group (GE), will participate in educational activities made available on digital platforms on "nursing care for patients with signs and symptoms of sepsis"
|
The digital educational platforms will be implemented through games of questions and answers, simulated cases sent via google forms about the nurse's performance in a critical care unit facing the patient with signs and symptoms of sepsis.
The questions in the games will aim to develop clinical judgment and quick decision-making in nursing students in order not to compromise the health care of the patient in sepsis.
|
Active Comparator: High-Fidelity Simulation
Nursing students in the Control Group (GC) will be exposed to high-fidelity simulation in the intensive care setting, where they must solve situations and procedures related to the nurse's performance in recognizing the signs and symptoms of sepsis.
|
The digital educational platforms will be implemented through games of questions and answers, simulated cases sent via google forms about the nurse's performance in a critical care unit facing the patient with signs and symptoms of sepsis.
The questions in the games will aim to develop clinical judgment and quick decision-making in nursing students in order not to compromise the health care of the patient in sepsis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive Performance (Baseline)
Time Frame: Applied before the intervention
|
Application of a questionnaire with ten multiple choice questions to assess the knowledge of nursing students about signs and sepsis symptoms
|
Applied before the intervention
|
Cognitive Performance (Post-Test)
Time Frame: Applied immediately after the intervention
|
Application of a questionnaire with ten multiple choice questions to assess the knowledge of nursing students about signs and sepsis symptoms
|
Applied immediately after the intervention
|
Cognitive Performance (Retention over time)
Time Frame: Applied thirty days after the intervention
|
Application of a questionnaire with ten multiple choice questions to assess the knowledge of nursing students about signs and sepsis symptoms
|
Applied thirty days after the intervention
|
Cognitive Performance (Retention over time)
Time Frame: Applied sixty days after the intervention
|
Application of a questionnaire with ten multiple choice questions to assess the knowledge of nursing students about signs and sepsis symptoms
|
Applied sixty days after the intervention
|
Clinical Judgment (Baseline)
Time Frame: Applied before the intervention
|
Evaluation of the development of clinical reasoning of nursing students.
The instrument Lasater clinical Judgment Rubric (LCJR)- Brazilian Version will be used.
It assesses 11 dimensions at four levels of clinical judgment (recognition, interpretation, response, reflection).
The total score ranges from 11 to 44, where the "initial" level generates one point, the "in development" level generates two points, the "proficient" level generates three points and the "exemplary" level generates four points.
|
Applied before the intervention
|
Clinical Judgment
Time Frame: Applied immediately after the intervention
|
Evaluation of the development of clinical reasoning of nursing students.
The instrument Lasater clinical Judgment Rubric (LCJR) - Brazilian Version will be used.
It assesses 11 dimensions at four levels of clinical judgment (recognition, interpretation, response, reflection).
The total score ranges from 11 to 44, where the "initial" level generates one point, the "in development" level generates two points, the "proficient" level generates three points and the "exemplary" level generates four points .
|
Applied immediately after the intervention
|
Clinical Judgment
Time Frame: Applied thirty days after the intervention
|
Evaluation of the development of clinical reasoning of nursing students.
The instrument Lasater clinical Judgment Rubric (LCJR) - Brazilian Version will be used.
It assesses 11 dimensions at four levels of clinical judgment (recognition, interpretation, response, reflection).
The total score ranges from 11 to 44, where the "initial" level generates one point, the "in development" level generates two points, the "proficient" level generates three points and the "exemplary" level generates four points.
|
Applied thirty days after the intervention
|
Clinical Judgment
Time Frame: Applied sixty days after the intervention
|
Evaluation of the development of clinical reasoning of nursing students.
The instrument Lasater Clinical Judgment Rubric (LCJR) - Brazilian Version will be used.
It assesses 11 dimensions at four levels of clinical judgment (recognition, interpretation, response, reflection).
The total score ranges from 11 to 44, where the "initial" level generates one point, the "in development" level generates two points, the "proficient" level generates three points and the "exemplary" level generates four points .
|
Applied sixty days after the intervention
|
Self-efficacy (Baseline)
Time Frame: Applied before the intervention
|
Assessment of satisfaction, learning, individual performance after educational actions.
A self-efficacy scale will be used.
IT'S self-applicable and has 13 items related to beliefs about their own abilities, motivation for action, coping with obstacles, predisposition to challenge, openness to experience, resilience in the face of failures, the influence of initial success on the the final success of an activity and the history of previous successes.
These items are represented by a Likert-type scale of agreement, containing five points, in which 1 represents the participant's total disagreement and 5 the total agreement.
Scores above 2.5 indicate that participants feel very capable.
|
Applied before the intervention
|
Self-efficacy
Time Frame: Applied immediately after the intervention
|
Assessment of satisfaction, learning, individual performance after educational actions.
A self-efficacy scale will be used.
IT'S self-applicable and has 13 items related to beliefs about their own abilities, motivation for action, coping with obstacles, predisposition to challenge, openness to experience, resilience in the face of failures, the influence of initial success on the the final success of an activity and the history of previous successes.
These items are represented by a Likert-type scale of agreement, containing five points, in which 1 represents the participant's total disagreement and 5 the total agreement.
Scores above 2.5 indicate that participants feel very capable.
|
Applied immediately after the intervention
|
Self-efficacy
Time Frame: Applied thirty days after the intervention
|
Assessment of satisfaction, learning, individual performance after educational actions.
A self-efficacy scale will be used.
IT'S self-applicable and has 13 items related to beliefs about their own abilities, motivation for action, coping with obstacles, predisposition to challenge, openness to experience, resilience in the face of failures, the influence of initial success on the the final success of an activity and the history of previous successes.
These items are represented by a Likert-type scale of agreement, containing five points, in which 1 represents the participant's total disagreement and 5 the total agreement.
Scores above 2.5 indicate that participants feel very capable.
|
Applied thirty days after the intervention
|
Self-efficacy
Time Frame: Applied sixty days after the intervention
|
Assessment of satisfaction, learning, individual performance after educational actions.
A self-efficacy scale will be used.
IT'S self-applicable and has 13 items related to beliefs about their own abilities, motivation for action, coping with obstacles, predisposition to challenge, openness to experience, resilience in the face of failures, the influence of initial success on the the final success of an activity and the history of previous successes.
These items are represented by a Likert-type scale of agreement, containing five points, in which 1 represents the participant's total disagreement and 5 the total agreement.
Scores above 2.5 indicate that participants feel very capable.
|
Applied sixty days after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Student stress (Baseline)
Time Frame: Before the intervention
|
Assessment of the intensity of stress among nursing students caused by pedagogical strategies: high-fidelity simulation and digital educational platforms.
The questionnaire will be applied.
It consists of 31 items and the answers are Likert type, scored from 0 to 3, depending on the degree of concern it generates for the student, as follows: nothing (0), a little (1), a lot (2) and extremely ( 3).
|
Before the intervention
|
Student stress
Time Frame: Applied immediately after the intervention
|
Assessment of the intensity of stress among nursing students caused by pedagogical strategies: high-fidelity simulation and digital educational platforms.
The questionnaire will be applied.
It consists of 31 items and the answers are Likert type, scored from 0 to 3, depending on the degree of concern it generates for the student, as follows: nothing (0), a little (1), a lot (2) and extremely ( 3).
|
Applied immediately after the intervention
|
Student stress
Time Frame: Applied thirty days after the intervention
|
Assessment of the intensity of stress among nursing students caused by pedagogical strategies: high-fidelity simulation and digital educational platforms.
The questionnaire will be applied.
It consists of 31 items and the answers are Likert type, scored from 0 to 3, depending on the degree of concern it generates for the student, as follows: nothing (0), a little (1), a lot (2) and extremely ( 3).
|
Applied thirty days after the intervention
|
Student stress
Time Frame: Applied sixty days after the intervention
|
Assessment of the intensity of stress among nursing students caused by pedagogical strategies: high-fidelity simulation and digital educational platforms.
The questionnaire will be applied.
It consists of 31 items and the answers are Likert type, scored from 0 to 3, depending on the degree of concern it generates for the student, as follows: nothing (0), a little (1), a lot (2) and extremely ( 3).
|
Applied sixty days after the intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marcia CS Magro, PhD, University of Brasilia
Publications and helpful links
General Publications
- Basak T, Unver V, Moss J, Watts P, Gaioso V. Beginning and advanced students' perceptions of the use of low- and high-fidelity mannequins in nursing simulation. Nurse Educ Today. 2016 Jan;36:37-43. doi: 10.1016/j.nedt.2015.07.020. Epub 2015 Jul 29.
- Silveira MS, Cogo ALP. The contributions of digital technologies in the teaching of nursing skills: an integrative review. Rev Gaucha Enferm. 2017 Jul 13;38(2):e66204. doi: 10.1590/1983-1447.2017.02.66204. English, Portuguese.
- Cogo ALP, Lopes EFDS, Perdomini FRI, Flores GE, Santos MRRD. Building and developing realistic simulation scenarios on safe drug administration. Rev Gaucha Enferm. 2019 Jan 10;40(spe):e20180175. doi: 10.1590/1983-1447.2019.20180175. English, Portuguese.
- Valentin B, Grottke O, Skorning M, Bergrath S, Fischermann H, Rortgen D, Mennig MT, Fitzner C, Muller MP, Kirschbaum C, Rossaint R, Beckers SK. Cortisol and alpha-amylase as stress response indicators during pre-hospital emergency medicine training with repetitive high-fidelity simulation and scenarios with standardized patients. Scand J Trauma Resusc Emerg Med. 2015 Apr 8;23:31. doi: 10.1186/s13049-015-0110-6.
- McGuire K, Lorenz R. Effect of Simulation on Learner Stress as Measured by Cortisol: An Integrative Review. Nurse Educ. 2018 Jan/Feb;43(1):45-49. doi: 10.1097/NNE.0000000000000393.
- Fraser K, McLaughlin K. Temporal pattern of emotions and cognitive load during simulation training and debriefing. Med Teach. 2019 Feb;41(2):184-189. doi: 10.1080/0142159X.2018.1459531. Epub 2018 Apr 24.
- Nieto Fernandez-Pacheco A, Castro Delgado R, Arcos Gonzalez P, Navarro Fernandez JL, Ceron Madrigal JJ, Juguera Rodriguez L, Perez Alonso N, Armero-Barranco D, Lidon Lopez Iborra M, Damian ET, Pardo Rios M. Analysis of performance and stress caused by a simulation of a mass casualty incident. Nurse Educ Today. 2018 Mar;62:52-57. doi: 10.1016/j.nedt.2017.12.016. Epub 2017 Dec 15.
- Mohammadi G, Tourdeh M, Ebrahimian A. Effect of simulation-based training method on the psychological health promotion in operating room students during the educational internship. J Educ Health Promot. 2019 Sep 30;8:172. doi: 10.4103/jehp.jehp_106_19. eCollection 2019.
- de Sena DP, Fabricio DD, da Silva VD, Bodanese LC, Franco AR. Comparative evaluation of video-based on-line course versus serious game for training medical students in cardiopulmonary resuscitation: A randomised trial. PLoS One. 2019 Apr 8;14(4):e0214722. doi: 10.1371/journal.pone.0214722. eCollection 2019.
- Blanie A, Amorim MA, Meffert A, Perrot C, Dondelli L, Benhamou D. Assessing validity evidence for a serious game dedicated to patient clinical deterioration and communication. Adv Simul (Lond). 2020 May 27;5:4. doi: 10.1186/s41077-020-00123-3. eCollection 2020.
- Fonseca LM, Aredes ND, Fernandes AM, Batalha LM, Apostolo JM, Martins JC, Rodrigues MA. Computer and laboratory simulation in the teaching of neonatal nursing: innovation and impact on learning. Rev Lat Am Enfermagem. 2016 Oct 10;24:e2808. doi: 10.1590/1518-8345.1005.2808.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 28233120.4.0000.0030
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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