- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03626272
Effects of the in Situ Simulation to Competencies in Cardiopulmonary Resuscitation in the Nursing Team.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brazil
- Recruiting
- Cleidilene Ramos Magalhaes
-
Contact:
- Cleidilene Ramos Magalhaes, Doctor
- Phone Number: 55 51 981448547
- Email: cleidilene.ufcspa@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- They must be nurses and nursing technicians.
Exclusion Criteria:
- not complete the evaluations
- be under 18 years old
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 8-month intervals
Participants will be submitted to the educational intervention with in situ simulation every 8 months.
|
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.
|
|
Active Comparator: 4-month intervals
Participants will be submitted to the educational intervention with in situ simulation every 4 months.
|
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.
|
|
Active Comparator: 2-month intervals
Participants will be submitted to the educational intervention with in situ simulation every 2 months.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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:
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%. |
up to eight months
|
|
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. |
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
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%. |
up to eight months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UFCSPA33
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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