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

August 9, 2018 updated by: Cleidilene Ramos Magalhães, Federal University of Health Science of Porto Alegre

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil
        • Recruiting
        • Cleidilene Ramos Magalhaes
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • They must be nurses and nursing technicians.

Exclusion Criteria:

  • not complete the evaluations
  • be under 18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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:

  • 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%.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of Health Science of Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UFCSPA33

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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