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Educational TechnologyNCT04940455

Effect of Realistic Simulation and Digital Educational Platforms for Learning Nursing Student

A study testing Educational digital platforms in people with Educational Technology, run by University of Brasilia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Educational Technology
What is being tested?
Educational digital platforms
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
Sep 2021to Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
  • -

Trial locations and contacts

No sites are listed yet.

Marcia CS Magro, PhD contact

5561982690888

marciamagro@unb.br

JANE WS NOGUEIRA, Master contact

5561999666669

janewalkiria@gmail.com

About this study

Official title: Effect of Realistic Simulation and Digital Educational Platforms for Learning Nursing Student: Randomized Clinical Trial

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.

Read the detailed 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.

Being tested
Educational digital platforms
Keywords
Educational Technology, Simulation Training, "Learning", Learning Curve, Active Learning, Nursing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational digital platformsOther

    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.

Study groups in NCT04940455
Study groupRoleWhat they receive
Educational digital platformsExperimentalNursing 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"
Receives: Other: Educational digital platforms
High-Fidelity SimulationActive comparatorNursing 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.
Receives: Other: Educational digital platforms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognitive Performance (Baseline)

    Application of a questionnaire with ten multiple choice questions to assess the knowledge of nursing students about signs and sepsis symptoms

    Measured: Applied before the intervention

  2. 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

    Measured: Applied immediately after the intervention

  3. 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

    Measured: Applied thirty days after the intervention

  4. 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

    Measured: Applied sixty days after the intervention

  5. 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.

    Measured: Applied before the intervention

  6. 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 .

    Measured: Applied immediately after the intervention

  7. 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.

    Measured: Applied thirty days after the intervention

  8. 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 .

    Measured: Applied sixty days after the intervention

  9. 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.

    Measured: Applied before the intervention

  10. 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.

    Measured: Applied immediately after the intervention

  11. 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.

    Measured: Applied thirty days after the intervention

  12. 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.

    Measured: Applied sixty days after the intervention

Secondary outcomes (4)
  1. 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).

    Measured: Before the intervention

  2. 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).

    Measured: Applied immediately after the intervention

  3. 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).

    Measured: Applied thirty days after the intervention

  4. 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).

    Measured: Applied sixty days after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2021
  2. Study startSep 2021 (estimated)
  3. Primary completionMar 2022 (estimated)
  4. Study completionSep 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04940455
Sponsor's protocol ID
28233120.4.0000.0030
Status last verified
Jun 2021
First submitted
17 Jun 2021
Last updated
28 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 28723986
  • 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.

    PubMed 26282193
  • 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.

    PubMed 30652802
  • 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.

    PubMed 25887044
  • 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.

    PubMed 28538244
  • 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.

    PubMed 29687734
  • 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.

    PubMed 29291462
  • 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.

    PubMed 31867357
  • 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.

    PubMed 30958836
  • 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.

    PubMed 32514382
  • 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.

    PubMed 27737376

Questions about this trial

What is this clinical trial studying?

A study testing Educational digital platforms in people with Educational Technology, run by University of Brasilia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marcia CS Magro, PhD (5561982690888, marciamagro@unb.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive Performance (Baseline) (time frame: Applied before the intervention). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04940455, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2021.

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