Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of the in Situ Simulation to Competencies in Cardiopulmonary Resuscitation in the Nursing Team.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03626272
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Cleidilene Ramos Magalhães, Federal University of Health Science of Porto Alegre

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.


Condition or disease Intervention/treatment Phase
Learning Disorders Other: educational intervention Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Health Services Research
Official Title: Effects of the Periodic Application of in Situ Simulation in Cardiopulmonary Resuscitation: Randomized Controlled Trial.
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 8-month intervals
Participants will be submitted to the educational intervention with in situ simulation every 8 months.
Other: educational intervention
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.
Other: educational intervention
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.
Other: educational intervention
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 Measures :
  1. 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%.


  2. 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.


  3. 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%.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • They must be nurses and nursing technicians.

Exclusion Criteria:

  • not complete the evaluations
  • be under 18 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626272


Locations
Layout table for location information
Brazil
Cleidilene Ramos Magalhaes Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil
Contact: Cleidilene Ramos Magalhaes, Doctor    55 51 981448547    cleidilene.ufcspa@gmail.com   
Sponsors and Collaborators
Federal University of Health Science of Porto Alegre
Layout table for additonal information
Responsible Party: Cleidilene Ramos Magalhães, Principal Investigator, Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier: NCT03626272    
Other Study ID Numbers: UFCSPA33
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Learning Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders