NCT04940455

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

June 28, 2021

Status Verified

June 1, 2021

Enrollment Period

6 months

First QC Date

June 17, 2021

Last Update Submit

June 25, 2021

Conditions

Keywords

Educational TechnologySimulation Training"Learning"Learning CurveActive LearningNursing

Outcome Measures

Primary Outcomes (12)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (4)

  • Student stress (Baseline)

    Before the intervention

  • Student stress

    Applied immediately after the intervention

  • Student stress

    Applied thirty days after the intervention

  • Student stress

    Applied sixty days after the intervention

Study Arms (2)

Educational digital platforms

EXPERIMENTAL

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"

Other: Educational digital platforms

High-Fidelity Simulation

ACTIVE COMPARATOR

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.

Other: Educational digital platforms

Interventions

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.

Educational digital platformsHigh-Fidelity Simulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged over 18 years;
  • Students approved in the discipline related to nursing care for adult and elderly patients.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • 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.

    PMID: 28723986BACKGROUND
  • 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.

    PMID: 26282193BACKGROUND
  • 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.

    PMID: 30652802BACKGROUND
  • 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.

    PMID: 25887044BACKGROUND
  • 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.

    PMID: 28538244BACKGROUND
  • 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.

    PMID: 29687734BACKGROUND
  • 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.

    PMID: 29291462BACKGROUND
  • 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.

    PMID: 31867357BACKGROUND
  • 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.

    PMID: 30958836BACKGROUND
  • 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.

    PMID: 32514382BACKGROUND
  • 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.

    PMID: 27737376BACKGROUND

Study Officials

  • Marcia CS Magro, PhD

    University of Brasilia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcia CS Magro, PhD

CONTACT

JANE WS NOGUEIRA, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigador, PhD

Study Record Dates

First Submitted

June 17, 2021

First Posted

June 25, 2021

Study Start

September 1, 2021

Primary Completion

March 1, 2022

Study Completion

September 1, 2022

Last Updated

June 28, 2021

Record last verified: 2021-06