Learning DisordersNCT03626272
Effects of the in Situ Simulation to Competencies in Cardiopulmonary Resuscitation in the Nursing Team.
A study testing educational intervention in people with Learning Disorders, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial summary
Introduction: In situ simulation is a methodology that meets the concept of permanent education, since it allows learning from the context of practice and in the work environment itself. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Learning Disorders
- What is being tested?
- educational intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2018to Aug 2019
- 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
- They must be nurses and nursing technicians.
Who cannot join
- not complete the evaluations
- be under 18 years old
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Cleidilene Ramos Magalhaes
Porto Alegre, Rio Grande do Sul
Cleidilene Ramos Magalhaes, Doctor, 55 51 981448547, cleidilene.ufcspa@gmail.com
About this study
Official title: Effects of the Periodic Application of in Situ Simulation in Cardiopulmonary Resuscitation: Randomized Controlled Trial.
Introduction: In situ simulation is a methodology that meets the concept of permanent education, since it allows learning from the context of practice and in the work environment itself.
Objective: to compare the development of skills (knowledge and skills) for CPR between groups submitted to different in situ simulation periodicities, and to identify the level of confidence to participate in a CPR.
Method: A randomized controlled, non-blind study comparing 3 periodicities of educational intervention performed by in situ simulation. This study will include nursing professionals from the nephrology department of a university hospital. The sample will be composed of 24 randomized participants in the groups, using opaque envelopes for each periodicity of training and professional category, being subdivided into 3 groups of periodicities with intervals of 2, 4 and 8 months. The instruments will evaluate the knowledge and skills in cardiopulmonary resuscitation and the perception of preparation for performing the maneuvers.
Read the detailed description
The objective is to compare the development of skills (knowledge and skills) for CPR between groups submitted to different in situ simulation periodicities, and to identify the level of confidence to attend a CPR.
- Conditions
- Learning Disorders
- Being tested
- educational intervention
- Medical subject headings
- Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational interventionOther
The simulation scenarios were constructed using the service environment, with real equipment and materials and a low fidelity mannequin. The interventions were not filmed, and the clinical cases elaborated were fictitious, with clear objectives and developed according to the context of the unit. The simulations took place during the working hours of the participants, with the expected duration of the 10 minutes (average) for the scenario, and the average duration of the debriefing was 10 minutes, which took place immediately after the simulation and in the same location of the scenario.
| Study group | Role | What they receive |
|---|---|---|
| 8-month intervals | Active comparator | Participants will be submitted to the educational intervention with in situ simulation every 8 months. Receives: Other: educational intervention |
| 4-month intervals | Active comparator | Participants will be submitted to the educational intervention with in situ simulation every 4 months. Receives: Other: educational intervention |
| 2-month intervals | Active comparator | Participants will be submitted to the educational intervention with in situ simulation every 2 months. Receives: Other: educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average number of hits in the test of knowledge on cardiopulmonary resuscitation
Measurement of the average/median/standard deviation of hits in the questions of the knowledge test, in each group (A, B, C,). This measurement was performed in two moments:
- Pre and post initial intervention: measure performed to evaluate the impact of the initial intervention on the participants' knowledge about the issue.
- After simulation intervention: measurement performed to evaluate the impact of the simulation intervention on the maintenance of knowledge, according to the periodicity group of intervention where the participant was allocated.
The measurement was applied to all groups at the same moments. The following tests were used to make comparisons among groups: Wilcoxon Test; Estimate of the size of the Cohen's d effect (paired data); Kruskal-Wallis Test - Dunn's Post Hoc; Cohen's d: Effect size measures by the " Cohen's d" method complemented by the Confidence Interval 95%.
Measured: up to eight months
Average number of hits in the accomplishment of a set of skills.
To compare, among groups exposed to the periodicity of different interventions, the average/median/standard deviation of hits in the accomplishment of a set of skills that matches the CPR procedures. Group A was evaluated when receiving the intervention every eight months, group B every four months, and group C every two months.
The Kruskal-Wallis Test was applied to compare the significance of the average outcomes among groups.
Measured: Group A was evaluated when receiving the intervention every eight months, group B every four months, and group C every two months.
Average agreement in the preparation for CPR
To Measure the average/median/standard deviation, referring to the agreement level of preparation for the accomplishment of CPR, in order to check the impact of the intervention performed according to the periodicity of application.
The following tests were used to make comparisons among groups: Wilcoxon Test; Estimate of the size of the Cohen's d effect (paired data); Kruskal-Wallis Test - Dunn's Post Hoc; Cohen's d: Effect size measures by the "Cohen's d" method complemented by the Confidence Interval 95%.
Measured: up to eight months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start1 Jan 2018
- Primary completionNov 2018 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Learning DisordersStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, non-blind controlled trial that will compare three periodicities of an educational intervention to be performed through in situ simulation. Group A will be submitted to intervention at 8-month intervals, group B every four months and group C every two months; each group will be divided into two subgroups, totaling six subgroups consisting of one nurse and three nursing technicians. The research was approved by the Research Ethics Committees of the Federal University of Health Sciences of Porto Alegre, under approval certificate no. 56516216.9.0000.5345, and of the Universidade Católica do Rio Grande do Sul/PUCRS, under approval certificate no. 56516216.9.3001.5336.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cleidilene Ramos Magalhães, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626272
- Sponsor's protocol ID
- UFCSPA33
- Status last verified
- Aug 2018
- First submitted
- 8 Mar 2018
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Periodic Application of in Situ Simulation in Cardiopulmonary Resuscitation: Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03626272
- Acronym / sponsor ID
- UFCSPA33
- Conditions
- Learning Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 13 Aug 2018 (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.
Introduction: In situ simulation is a methodology that meets the concept of permanent education, since it allows learning from the context of practice and in the work environment itself.
Objective: to compare the development of skills (knowledge and skills) for CPR between groups submitted to different in situ simulation periodicities, and to identify the level of confidence to participate in a CPR.
Method: A randomized controlled, non-blind study comparing 3 periodicities of educational intervention performed by in situ simulation. This study will include nursing professionals from the nephrology department of a university hospital. The sample will be composed of 24 randomized participants in the groups, using opaque envelopes for each periodicity of training and professional category, being subdivided into 3 groups of periodicities with intervals of 2, 4 and 8 months. The instruments will evaluate the knowledge and skills in cardiopulmonary resuscitation and the perception of preparation for performing the maneuvers.
Detailed description
The objective is to compare the development of skills (knowledge and skills) for CPR between groups submitted to different in situ simulation periodicities, and to identify the level of confidence to attend a CPR.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a randomized, non-blind controlled trial that will compare three periodicities of an educational intervention to be performed through in situ simulation. Group A will be submitted to intervention at 8-month intervals, group B every four months and group C every two months; each group will be divided into two subgroups, totaling six subgroups consisting of one nurse and three nursing technicians. The research was approved by the Research Ethics Committees of the Federal University of Health Sciences of Porto Alegre, under approval certificate no. 56516216.9.0000.5345, and of the Universidade Católica do Rio Grande do Sul/PUCRS, under approval certificate no. 56516216.9.3001.5336.
| Arm | Type | Receives |
|---|---|---|
| 8-month intervals | Active comparator | Other: educational interventionParticipants will be submitted to the educational intervention with in situ simulation every 8 months. |
| 4-month intervals | Active comparator | Other: educational interventionParticipants will be submitted to the educational intervention with in situ simulation every 4 months. |
| 2-month intervals | Active comparator | Other: educational interventionParticipants will be submitted to the educational intervention with in situ simulation every 2 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- They must be nurses and nursing technicians.
Key exclusion criteria (2 listed)
- not complete the evaluations
- be under 18 years old
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 |
|---|---|---|
| educational interventionThe simulation scenarios were constructed using the service environment, with real equipment and materials and a low fidelity mannequin. The interventions were not filmed, and the clinical cases elaborated were fictitious, with clear objectives and developed according to the context of the unit. The simulations took place during the working hours of the participants, with the expected duration of the 10 minutes (average) for the scenario, and the average duration of the debriefing was 10 minutes, which took place immediately after the simulation and in the same location of the scenario. | Other | 2-month intervals, 4-month intervals, 8-month intervals |
Primary outcome
Average number of hits in the test of knowledge on cardiopulmonary resuscitation
Time frame: up to eight months
Measurement of the average/median/standard deviation of hits in the questions of the knowledge test, in each group (A, B, C,). This measurement was performed in two moments: * Pre and post initial intervention: measure performed to evaluate the impact of the initial intervention on the participants' knowledge about the issue. * After simulation intervention: measurement performed to evaluate the impact of the simulation intervention on the maintenance of knowledge, according to the periodicity group of intervention where the participant was allocated. The measurement was applied to all groups at the same moments. The following tests were used to make comparisons among groups: Wilcoxon Test; Estimate of the size of the Cohen's d effect (paired data); Kruskal-Wallis Test - Dunn's Post Hoc; Cohen's d: Effect size measures by the " Cohen's d" method complemented by the Confidence Interval 95%.
Average number of hits in the accomplishment of a set of skills.
Time frame: Group A was evaluated when receiving the intervention every eight months, group B every four months, and group C every two months.
To compare, among groups exposed to the periodicity of different interventions, the average/median/standard deviation of hits in the accomplishment of a set of skills that matches the CPR procedures. Group A was evaluated when receiving the intervention every eight months, group B every four months, and group C every two months. The Kruskal-Wallis Test was applied to compare the significance of the average outcomes among groups.
Average agreement in the preparation for CPR
Time frame: up to eight months
To Measure the average/median/standard deviation, referring to the agreement level of preparation for the accomplishment of CPR, in order to check the impact of the intervention performed according to the periodicity of application. The following tests were used to make comparisons among groups: Wilcoxon Test; Estimate of the size of the Cohen's d effect (paired data); Kruskal-Wallis Test - Dunn's Post Hoc; Cohen's d: Effect size measures by the "Cohen's d" method complemented by the Confidence Interval 95%.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational intervention in people with Learning Disorders, run by Federal University of Health Science of Porto Alegre 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 1 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 13 Aug 2018. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average number of hits in the test of knowledge on cardiopulmonary resuscitation (time frame: up to eight months). 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?
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 2018.