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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04940455
Other study ID # 28233120.4.0000.0030
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2021
Est. completion date September 2022

Study information

Verified date June 2021
Source University of Brasilia
Contact Marcia CS Magro, PhD
Phone 5561982690888
Email marciamagro@unb.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Teaching modalities that integrate digital educational technologies, such as educational games, dummies and simulated environments, develop critical thinking in students, the absorption of significant learning and the consequent reduction in the exposure of patients to the damage associated with health care. Thus, this study will evaluate the effectiveness of simulation strategies and digital educational platforms in the teaching-learning process, in self-confidence and its implications for the physiological variables and stressful feelings of undergraduate nursing students. Our hypothesis is that students submitted to the use of digital platforms will present lower levels of self-efficacy, capacity for clinical judgment and retention of knowledge when compared to those who were submitted to the simulation strategy.


Description:

The study will be carried out in the simulation laboratory of two Higher Education Institutions, one public and the other private in the city of Brasília, Brazil. The sample will consist of 100 students randomized into an experimental group (n=50) and a control group (n=50). Students enrolled in the undergraduate nursing course, aged 18 years or over, will be eligible; have minimal approval in a discipline related to the content of "Nursing Care for Adult Patients". Students who work actively in the scenario of patient care in critical and risk situations will be excluded; members of the Academic League of Realistic Health Simulation and those with prior training in the health field. It is expected that nursing students, through active and innovative strategies, will be able to obtain and retain greater knowledge, raise levels of self-efficacy and clinical judgment, for their performance in clinical practice.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date September 2022
Est. primary completion date March 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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. -

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Educational digital platforms
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Brasilia

References & Publications (11)

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. — View Citation

Blanié 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. — View Citation

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. Portuguese, English. — View Citation

de Sena DP, Fabrício 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. — View Citation

Fonseca LM, Aredes ND, Fernandes AM, Batalha LM, Apóstolo 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. English, Portuguese, Spanish. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Nieto Fernández-Pacheco A, Castro Delgado R, Arcos González P, Navarro Fernández JL, Cerón Madrigal JJ, Juguera Rodriguez L, Perez Alonso N, Armero-Barranco D, Lidon López 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. — View Citation

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. Review. Portuguese, English. — View Citation

Valentin B, Grottke O, Skorning M, Bergrath S, Fischermann H, Rörtgen D, Mennig MT, Fitzner C, Müller 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. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Cognitive Performance (Baseline) 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
Primary Cognitive Performance (Post-Test) 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
Primary Cognitive Performance (Retention over time) 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
Primary Cognitive Performance (Retention over time) 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
Primary Clinical Judgment (Baseline) 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
Primary Clinical Judgment 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
Primary Clinical Judgment 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
Primary Clinical Judgment 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
Primary Self-efficacy (Baseline) 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
Primary Self-efficacy 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
Primary Self-efficacy 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
Primary Self-efficacy 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 Student stress (Baseline) 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
Secondary Student stress 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
Secondary Student stress 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
Secondary Student stress 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
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