Simulation TrainingNCT06472401
Integrated Learning Support System Based on Immersive Simulated Training for Nursing Students
A study testing Integrated Learning Support System and Standard Learning Model in people with Simulation Training and Learning, run by University of Brasilia at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Simulation Training, Learning, Educational Technology
- What is being tested?
- Integrated Learning Support System and Standard Learning Model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2024to Dec 2025
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Care Skills and Simulation Laboratory
Brasília, Federal District, 72220-275
Marcia Cristina S Magro, PhD, +5561982690888
About this study
Official title: Integrated Learning Support System Based on Immersive Simulated Training for Nursing Students: Randomized Controlled Trial
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.
Read the detailed description
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
- Simulation Training, Learning, Educational Technology, Nephrotoxicity, Physiological Stress
- Being tested
- Integrated Learning Support System, Standard Learning Model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Learning Support SystemOther
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 ModelOther
Students will receive standard simulation preparation consisting of:
- Expository and dialogued theoretical class.
| Study group | Role | What they receive |
|---|---|---|
| Integrated Learning Support System (ILSS) | Experimental | 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 Receives: Other: Integrated Learning Support System |
| Standard Learning Model (SLM) | Active comparator | 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. Receives: Other: Standard Learning Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge about Prevention of Contrast-Induced Nephrotoxicity (baseline)
Assessment of knowledge about prevention of contrast-induced nephrotoxicity using a standardized questionnaire. Unit of Measure: Percentage of correct responses
Measured: Evaluated one week before participation in the simulation scenario.
Knowledge about Prevention of Contrast-Induced Nephrotoxicity (one week before simulation)
Assessment of knowledge about prevention of contrast-induced nephrotoxicity using a standardized questionnaire. Unit of Measure: Percentage of correct responses
Measured: Evaluated Immediately after participation in the simulation scenario
Knowledge about Prevention of Contrast-Induced Nephrotoxicity (thirty days after simulation)
Assessment of knowledge about prevention of contrast-induced nephrotoxicity using a standardized questionnaire. Unit of Measure: Percentage of correct responses
Measured: Evaluated Thirty days after participation in the simulation scenario
Secondary outcomes (7)
Practical Performance in Realistic Simulation
This measure evaluates the student's ability to perform specific tasks and procedures accurately and efficiently in a simulated clinical environment. Assessment of student's practical performance during the realistic simulation scenario using a standardized performance checklist. Unit of Measure: Percentage of completed tasks according to the performance checklist. Measurement Tool: Standardized performance checklist
Measured: During the simulated scenario.
Clinical Judgment on Prevention of Contrast-Induced Nephrotoxicity (baseline)
Assessment of clinical judgment regarding the prevention of contrast-induced nephrotoxicity using the Lasater Clinical Judgment Rubric - Brazilian Version (LCJR-BV). Unit of Measure: Scores on the LCJR-BV, which range from 11 to 44 points. The scoring system is designed to identify the level of clinical performance presented by an individual and includes four levels for each of the 11 dimensions:
One point for each behavior considered "Novice" Two points for behavior considered "Developing" Three points for behavior considered "Proficient" Four points for behavior considered "Exemplary"
Scores between 11 and 19 points are considered "Novice"; scores between 20 and 28 points are considered "Developing"; scores between 29 and 37 points are considered "Proficient"; and scores between 38 and 44 points are considered "Exemplary".
Measured: Evaluated one week before participation in the simulation scenario
Clinical Judgment on Prevention of Contrast-Induced Nephrotoxicity (immediately after simulation)
Assessment of clinical judgment regarding the prevention of contrast-induced nephrotoxicity using the Lasater Clinical Judgment Rubric - Brazilian Version (LCJR-BV). Unit of Measure: Scores on the LCJR-BV, which range from 11 to 44 points. The scoring system is designed to identify the level of clinical performance presented by an individual and includes four levels for each of the 11 dimensions:
One point for each behavior considered "Novice" Two points for behavior considered "Developing" Three points for behavior considered "Proficient" Four points for behavior considered "Exemplary"
Scores between 11 and 19 points are considered "Novice"; scores between 20 and 28 points are considered "Developing"; scores between 29 and 37 points are considered "Proficient"; and scores between 38 and 44 points are considered "Exemplary".
Measured: Evaluated immediately after participation in the simulation scenario
Clinical Judgment on Prevention of Contrast-Induced Nephrotoxicity (thirty days after simulation)
Assessment of clinical judgment regarding the prevention of contrast-induced nephrotoxicity using the Lasater Clinical Judgment Rubric - Brazilian Version (LCJR-BV). Unit of Measure: Scores on the LCJR-BV, which range from 11 to 44 points. The scoring system is designed to identify the level of clinical performance presented by an individual and includes four levels for each of the 11 dimensions:
One point for each behavior considered "Novice" Two points for behavior considered "Developing" Three points for behavior considered "Proficient" Four points for behavior considered "Exemplary"
Scores between 11 and 19 points are considered "Novice"; scores between 20 and 28 points are considered "Developing"; scores between 29 and 37 points are considered "Proficient"; and scores between 38 and 44 points are considered "Exemplary".
Measured: Evaluated thirty days after participation in the simulation scenario
Depression, Anxiety and Stress (baseline)
Gradation of depression, anxiety, and stress during different stages of the study using the Depression, Anxiety, and Stress Scale - 21 items (DASS-21).
Unit of Measure:
Scores on the DASS-21, which range from 0 to 63 points, subdivided into three factors: depression, anxiety, and stress. Each factor is assessed using a four-point Likert scale (0 - did not apply at all; 1 - applied to some degree, or for a short time; 2 - applied to a considerable degree, or for a good part of the time; 3 - applied very much, or most of the time).
Scoring Interpretation:
Depression: Normal (0-9), Mild (10-13), Moderate (14-20), Severe (21-27), Extremely Severe (28+) Anxiety: Normal (0-7), Mild (8-9), Moderate (10-14), Severe (15-19), Extremely Severe (20+) Stress: Normal (0-14), Mild (15-18), Moderate (19-25), Severe (26-33), Extremely Severe (34+)
Measured: Evaluated one week before participation in the simulation scenario
Depression, Anxiety and Stress (immediately after simulation)
Gradation of depression, anxiety, and stress during different stages of the study using the Depression, Anxiety, and Stress Scale - 21 items (DASS-21).
Unit of Measure:
Scores on the DASS-21, which range from 0 to 63 points, subdivided into three factors: depression, anxiety, and stress. Each factor is assessed using a four-point Likert scale (0 - did not apply at all; 1 - applied to some degree, or for a short time; 2 - applied to a considerable degree, or for a good part of the time; 3 - applied very much, or most of the time).
Scoring Interpretation:
Depression: Normal (0-9), Mild (10-13), Moderate (14-20), Severe (21-27), Extremely Severe (28+) Anxiety: Normal (0-7), Mild (8-9), Moderate (10-14), Severe (15-19), Extremely Severe (20+) Stress: Normal (0-14), Mild (15-18), Moderate (19-25), Severe (26-33), Extremely Severe (34+)
Measured: Evaluated immediately after participation in the simulation scenario
Depression, Anxiety and Stress (thirty days after simulation)
Gradation of depression, anxiety, and stress during different stages of the study using the Depression, Anxiety, and Stress Scale - 21 items (DASS-21).
Unit of Measure:
Scores on the DASS-21, which range from 0 to 63 points, subdivided into three factors: depression, anxiety, and stress. Each factor is assessed using a four-point Likert scale (0 - did not apply at all; 1 - applied to some degree, or for a short time; 2 - applied to a considerable degree, or for a good part of the time; 3 - applied very much, or most of the time).
Scoring Interpretation:
Depression: Normal (0-9), Mild (10-13), Moderate (14-20), Severe (21-27), Extremely Severe (28+) Anxiety: Normal (0-7), Mild (8-9), Moderate (10-14), Severe (15-19), Extremely Severe (20+) Stress: Normal (0-14), Mild (15-18), Moderate (19-25), Severe (26-33), Extremely Severe (34+)
Measured: Evaluated thirty days after participation in the simulation scenario
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Aug 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Simulation TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Investigator, Outcomes assessor
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcia Cristina da Silva Magro, University of Brasilia
- Investigators
- Marcia CS Magro, PhD, Study director, University of BrasiliaBreno S Santana, MsC, Principal investigator, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472401
- Sponsor's protocol ID
- 55509622.9.3001.5650
- Status last verified
- Jul 2024
- First submitted
- 11 May 2023
- Last updated
- 31 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32234667Lasater 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.
PubMed 18019107Grimes 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.
PubMed 11812579Dreifuerst 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.
PubMed 22495923Cheng 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.
PubMed 29449994
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Learning Support System Based on Immersive Simulated Training for Nursing Students: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06472401
- Acronym / sponsor ID
- 55509622.9.3001.5650
- Conditions
- Simulation Training, Learning, Educational Technology, Nephrotoxicity, Physiological Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Learning Support System (ILSS) | Experimental | Other: Integrated Learning Support SystemFor 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 |
| Standard Learning Model (SLM) | Active comparator | Other: Standard Learning ModelIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Learning Support SystemStudents 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 | Other | Integrated Learning Support System (ILSS) |
| Standard Learning ModelStudents will receive standard simulation preparation consisting of: - Expository and dialogued theoretical class. | Other | Standard Learning Model (SLM) |
Primary outcome
Knowledge about Prevention of Contrast-Induced Nephrotoxicity (baseline)
Time frame: Evaluated one week before participation in the simulation scenario.
Assessment of knowledge about prevention of contrast-induced nephrotoxicity using a standardized questionnaire. Unit of Measure: Percentage of correct responses
Knowledge about Prevention of Contrast-Induced Nephrotoxicity (one week before simulation)
Time frame: Evaluated Immediately after participation in the simulation scenario
Assessment of knowledge about prevention of contrast-induced nephrotoxicity using a standardized questionnaire. Unit of Measure: Percentage of correct responses
Knowledge about Prevention of Contrast-Induced Nephrotoxicity (thirty days after simulation)
Time frame: Evaluated Thirty days after participation in the simulation scenario
Assessment of knowledge about prevention of contrast-induced nephrotoxicity using a standardized questionnaire. Unit of Measure: Percentage of correct responses
7 secondary outcomes
Practical Performance in Realistic Simulation
Time frame: During the simulated scenario.
Clinical Judgment on Prevention of Contrast-Induced Nephrotoxicity (baseline)
Time frame: Evaluated one week before participation in the simulation scenario
Clinical Judgment on Prevention of Contrast-Induced Nephrotoxicity (immediately after simulation)
Time frame: Evaluated immediately after participation in the simulation scenario
Clinical Judgment on Prevention of Contrast-Induced Nephrotoxicity (thirty days after simulation)
Time frame: Evaluated thirty days after participation in the simulation scenario
Depression, Anxiety and Stress (baseline)
Time frame: Evaluated one week before participation in the simulation scenario
Depression, Anxiety and Stress (immediately after simulation)
Time frame: Evaluated immediately after participation in the simulation scenario
Depression, Anxiety and Stress (thirty days after simulation)
Time frame: Evaluated thirty days after participation in the simulation scenario
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Background: PubMed 32234667Salvarani 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.
- Background: PubMed 18019107Lasater 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.
- Background: PubMed 11812579Grimes 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.
- Background: PubMed 22495923Dreifuerst 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.
- Background: PubMed 29449994Cheng 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcia CS Magro, PhD study director
University of Brasilia
Breno S Santana, MsC principal investigator
University of Brasilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Learning Support System and Standard Learning Model in people with Simulation Training and Learning, run by University of Brasilia at 1 site in Brazil.
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 3 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 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Breno S Santana, MsC (+5561982085031, bresousas@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge about Prevention of Contrast-Induced Nephrotoxicity (baseline) (time frame: Evaluated one week before participation in the simulation scenario.). The study lists 3 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 NCT06472401, which also lists 5 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 31 Jul 2024.