Learning Process in Nursing GraduationNCT04512183
Effectiveness of Simulation With Nursing Students in the Care of Patients With Sepsis
A study testing High-Fidelity Simulation and Low-Fidelity Simulation in people with Learning Process in Nursing Graduation and Stress, run by University of Brasilia.
Trial summary
Simulation is an active teaching strategy capable of reproducing real situations and allowing practical experiences, in which the student is the protagonist of his own knowledge. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Learning Process in Nursing Graduation, Stress
- What is being tested?
- High-Fidelity Simulation and Low-Fidelity Simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 31 Aug 2021
- 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
- Students approved in the discipline related to nursing care for adult and elderly patients;
- Aged over 18 years.
Who cannot join
- Who have experience in the health field (firefighters and nursing technicians, among others);
- Members of the Health Simulation League;
- Those who do not complete all stages of the research.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of Simulation in the Cognitive, Physiological and Emotional Sphere of Nursing Students in Caring for Patients With Signs of Sepsis: Crossover Clinical Trial
Simulation is an active teaching strategy capable of reproducing real situations and allowing practical experiences, in which the student is the protagonist of his own knowledge. Scientific evidence highlights, that exposure to the unknown or new can generate stress to the individual, but when dosed, to a certain extent it can increase the level of knowledge. Not infrequently, the lack of stress control can trigger physiological and subjective changes resulting from the increase in its level, such as situations that include the implementation of simulation scenarios in pedagogical teaching models.
Read the detailed description
Objective:
To evaluate the effect of simulation (high and low fidelity) on the cognitive, physiological and emotional sphere of nursing students in caring for patients with signs of sepsis.
Hypothesis of the study:
Null hypothesis: Students undergoing high-fidelity simulation will show similar levels of stress, cognitive performance and retention of knowledge in relation to those who will perform low-fidelity simulation in patients with signs of sepsis.
Alternative hypothesis: The cognitive performance and stress will be higher in students who experience high fidelity simulation when compared to students who experience low fidelity simulation.
- Conditions
- Learning Process in Nursing Graduation, Stress
- Being tested
- High-Fidelity Simulation, Low-Fidelity Simulation
- Keywords
- Simulation, Stress, Psychological, Nursing, Education, Simulation Training, Learning
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Fidelity SimulationOther
Teaching strategy based on high-fidelity simulation, which simulates the reality of health care to promote meaningful learning.
Low-Fidelity SimulationOther
Teaching strategy based on low-fidelity simulation, which simulates the reality of health care using less technological and less interactive mannequins.
| Study group | Role | What they receive |
|---|---|---|
| High-Fidelity Simulation | Experimental | First, students will go through an inverted class on sepsis. Then, they will be submitted to high-fidelity simulation scenarios to care for patients with sespe. After the scenario, the students' physiological parameters (blood pressure, heart rate, body temperature, respiratory rate and oxygen saturation) will be measured. After the scenario, students will go through a reflective debriefing session. Receives: Other: High-Fidelity Simulation |
| Low-Fidelity Simulation | Active comparator | First, students will go through an inverted class on sepsis. Then, they will be submitted to low-fidelity simulation scenarios to care for patients with sespe. After the scenario, the students' physiological parameters (blood pressure, heart rate, body temperature, respiratory rate and oxygen saturation) will be measured. After the scenario, students will go through a feedback session. Receives: Other: Low-Fidelity Simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Performance (Baseline)
Students' knowledge about nursing care in sepsis measured using a structured questionnaire with six multiple-choice questions
Measured: Applied before the intervention
Cognitive Performance (Post-test)
Students' knowledge about nursing care in sepsis measured using a structured questionnaire with six multiple-choice questions
Measured: Applied immediately after the intervention
Cognitive Performance (Retention)
Students' knowledge about nursing care in sepsis measured using a structured questionnaire with six multiple-choice questions
Measured: Applied thirty days after the intervention
Secondary outcomes (2)
Student stress (Baseline)
Assessment of students' stress intensity with pedagogical activities through the application of the Kezkak Stress Scale. This scale has 31 items of the Likert type of 4 points, being: 1 - Nothing stressful; 2 - A little stressful; 3 - Very stressful; 4 - Extremely stressful. The value 1 means less stress and 4 more stress.
Measured: Before the intervention
Student stress (Post-test)
Assessment of students' stress intensity with pedagogical activities through the application of the Kezkak Stress Scale. This scale has 31 items of the Likert type of 4 points, being: 1 - Nothing stressful; 2 - A little stressful; 3 - Very stressful; 4 - Extremely stressful. The value 1 means less stress and 4 more stress.
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion30 Mar 2021 (estimated)
- Study completion31 Aug 2021 (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 Learning Process in Nursing GraduationStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 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, Principal investigator, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512183
- Sponsor's protocol ID
- 3906816
- Status last verified
- Aug 2020
- First submitted
- 2 Aug 2020
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boostel R, Felix JVC, Bortolato-Major C, Pedrolo E, Vayego SA, Mantovani MF. Stress of nursing students in clinical simulation: a randomized clinical trial. Rev Bras Enferm. 2018 May;71(3):967-974. doi: 10.1590/0034-7167-2017-0187. English, Portuguese.
PubMed 29924167Kaneko RMU, Lopes MHBM. Realistic health care simulation scenario: what is relevant for its design? Rev Esc Enferm USP. 2019 May 30;53:e03453. doi: 10.1590/S1980-220X2018015703453. English, Portuguese.
PubMed 31166535Bingham AL, Sen S, Finn LA, Cawley MJ. Retention of advanced cardiac life support knowledge and skills following high-fidelity mannequin simulation training. Am J Pharm Educ. 2015 Feb 17;79(1):12. doi: 10.5688/ajpe79112.
PubMed 25741028Machado FR, Assuncao MS, Cavalcanti AB, Japiassu AM, Azevedo LC, Oliveira MC. Getting a consensus: advantages and disadvantages of Sepsis 3 in the context of middle-income settings. Rev Bras Ter Intensiva. 2016 Oct-Dec;28(4):361-365. doi: 10.5935/0103-507X.20160068. No abstract available.
PubMed 28099632Englert NC, McDermott D. Back to Fundamentals: Using High- and Low-Fidelity Simulation to Provide Reinforcement of Preventative Measures for Sepsis. Crit Care Nurs Q. 2016 Jan-Mar;39(1):14-23. doi: 10.1097/CNQ.0000000000000097.
PubMed 26633154
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Simulation in the Cognitive, Physiological and Emotional Sphere of Nursing Students in Caring for Patients With Signs of Sepsis: Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT04512183
- Acronym / sponsor ID
- 3906816
- Conditions
- Learning Process in Nursing Graduation, Stress
- Keywords
- Simulation, Stress, Psychological, Nursing, Education, Simulation Training, Learning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 13 Aug 2020 (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.
Simulation is an active teaching strategy capable of reproducing real situations and allowing practical experiences, in which the student is the protagonist of his own knowledge. Scientific evidence highlights, that exposure to the unknown or new can generate stress to the individual, but when dosed, to a certain extent it can increase the level of knowledge. Not infrequently, the lack of stress control can trigger physiological and subjective changes resulting from the increase in its level, such as situations that include the implementation of simulation scenarios in pedagogical teaching models.
Detailed description
Objective:
To evaluate the effect of simulation (high and low fidelity) on the cognitive, physiological and emotional sphere of nursing students in caring for patients with signs of sepsis.
Hypothesis of the study:
Null hypothesis: Students undergoing high-fidelity simulation will show similar levels of stress, cognitive performance and retention of knowledge in relation to those who will perform low-fidelity simulation in patients with signs of sepsis.
Alternative hypothesis: The cognitive performance and stress will be higher in students who experience high fidelity simulation when compared to students who experience low fidelity simulation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Fidelity Simulation | Experimental | Other: High-Fidelity SimulationFirst, students will go through an inverted class on sepsis. Then, they will be submitted to high-fidelity simulation scenarios to care for patients with sespe. After the scenario, the students' physiological parameters (blood pressure, heart rate, body temperature, respiratory rate and oxygen saturation) will be measured. After the scenario, students will go through a reflective debriefing session. |
| Low-Fidelity Simulation | Active comparator | Other: Low-Fidelity SimulationFirst, students will go through an inverted class on sepsis. Then, they will be submitted to low-fidelity simulation scenarios to care for patients with sespe. After the scenario, the students' physiological parameters (blood pressure, heart rate, body temperature, respiratory rate and oxygen saturation) will be measured. After the scenario, students will go through a feedback session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Students approved in the discipline related to nursing care for adult and elderly patients;
- Aged over 18 years.
Key exclusion criteria (3 listed)
- Who have experience in the health field (firefighters and nursing technicians, among others);
- Members of the Health Simulation League;
- Those who do not complete all stages of the research.
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 |
|---|---|---|
| High-Fidelity SimulationTeaching strategy based on high-fidelity simulation, which simulates the reality of health care to promote meaningful learning. | Other | High-Fidelity Simulation |
| Low-Fidelity SimulationTeaching strategy based on low-fidelity simulation, which simulates the reality of health care using less technological and less interactive mannequins. | Other | Low-Fidelity Simulation |
Primary outcome
Cognitive Performance (Baseline)
Time frame: Applied before the intervention
Students' knowledge about nursing care in sepsis measured using a structured questionnaire with six multiple-choice questions
Cognitive Performance (Post-test)
Time frame: Applied immediately after the intervention
Students' knowledge about nursing care in sepsis measured using a structured questionnaire with six multiple-choice questions
Cognitive Performance (Retention)
Time frame: Applied thirty days after the intervention
Students' knowledge about nursing care in sepsis measured using a structured questionnaire with six multiple-choice questions
2 secondary outcomes
Student stress (Baseline)
Time frame: Before the intervention
Student stress (Post-test)
Time frame: Immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Background: PubMed 29924167Boostel R, Felix JVC, Bortolato-Major C, Pedrolo E, Vayego SA, Mantovani MF. Stress of nursing students in clinical simulation: a randomized clinical trial. Rev Bras Enferm. 2018 May;71(3):967-974. doi: 10.1590/0034-7167-2017-0187. English, Portuguese.
- Background: PubMed 31166535Kaneko RMU, Lopes MHBM. Realistic health care simulation scenario: what is relevant for its design? Rev Esc Enferm USP. 2019 May 30;53:e03453. doi: 10.1590/S1980-220X2018015703453. English, Portuguese.
- Background: PubMed 25741028Bingham AL, Sen S, Finn LA, Cawley MJ. Retention of advanced cardiac life support knowledge and skills following high-fidelity mannequin simulation training. Am J Pharm Educ. 2015 Feb 17;79(1):12. doi: 10.5688/ajpe79112.
- Background: PubMed 28099632Machado FR, Assuncao MS, Cavalcanti AB, Japiassu AM, Azevedo LC, Oliveira MC. Getting a consensus: advantages and disadvantages of Sepsis 3 in the context of middle-income settings. Rev Bras Ter Intensiva. 2016 Oct-Dec;28(4):361-365. doi: 10.5935/0103-507X.20160068. No abstract available.
- Background: PubMed 26633154Englert NC, McDermott D. Back to Fundamentals: Using High- and Low-Fidelity Simulation to Provide Reinforcement of Preventative Measures for Sepsis. Crit Care Nurs Q. 2016 Jan-Mar;39(1):14-23. doi: 10.1097/CNQ.0000000000000097.
- 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 principal investigator
University of Brasilia
Questions about this trial
What is this clinical trial studying?
A study testing High-Fidelity Simulation and Low-Fidelity Simulation in people with Learning Process in Nursing Graduation and Stress, 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 3 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 13 Aug 2020. 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 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 NCT04512183, 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 13 Aug 2020.