Effects of the in Situ Simulation to Competencies in Cardiopulmonary Resuscitation in the Nursing Team.
Primary Purpose
Learning Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
educational intervention
Sponsored by
About this trial
This is an interventional health services research trial for Learning Disorders
Eligibility Criteria
Inclusion Criteria:
- They must be nurses and nursing technicians.
Exclusion Criteria:
- not complete the evaluations
- be under 18 years old
Sites / Locations
- Cleidilene Ramos MagalhaesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
8-month intervals
4-month intervals
2-month intervals
Arm Description
Participants will be submitted to the educational intervention with in situ simulation every 8 months.
Participants will be submitted to the educational intervention with in situ simulation every 4 months.
Participants will be submitted to the educational intervention with in situ simulation every 2 months.
Outcomes
Primary Outcome Measures
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%.
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.
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%.
Secondary Outcome Measures
Full Information
NCT ID
NCT03626272
First Posted
March 8, 2018
Last Updated
August 9, 2018
Sponsor
Federal University of Health Science of Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT03626272
Brief Title
Effects of the in Situ Simulation to Competencies in Cardiopulmonary Resuscitation in the Nursing Team.
Official Title
Effects of the Periodic Application of in Situ Simulation in Cardiopulmonary Resuscitation: Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
August 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Learning Disorders
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
8-month intervals
Arm Type
Active Comparator
Arm Description
Participants will be submitted to the educational intervention with in situ simulation every 8 months.
Arm Title
4-month intervals
Arm Type
Active Comparator
Arm Description
Participants will be submitted to the educational intervention with in situ simulation every 4 months.
Arm Title
2-month intervals
Arm Type
Active Comparator
Arm Description
Participants will be submitted to the educational intervention with in situ simulation every 2 months.
Intervention Type
Other
Intervention Name(s)
educational intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Average number of hits in the test of knowledge on cardiopulmonary resuscitation
Description
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%.
Time Frame
up to eight months
Title
Average number of hits in the accomplishment of a set of skills.
Description
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.
Time Frame
Group A was evaluated when receiving the intervention every eight months, group B every four months, and group C every two months.
Title
Average agreement in the preparation for CPR
Description
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%.
Time Frame
up to eight months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
They must be nurses and nursing technicians.
Exclusion Criteria:
not complete the evaluations
be under 18 years old
Facility Information:
Facility Name
Cleidilene Ramos Magalhaes
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cleidilene Ramos Magalhaes, Doctor
Phone
55 51 981448547
Email
cleidilene.ufcspa@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effects of the in Situ Simulation to Competencies in Cardiopulmonary Resuscitation in the Nursing Team.
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