Mindfulness and Executive Functions for Prediction of Non-technical Skills of Students in Pediatric Medical Simulations (MindExSim)

July 16, 2020 updated by: Medical University of Bialystok

Mindfulness and Executive Functions for Prediction of Non-technical Skills of Students in High-fidelity Medical Simulations in Pediatric Emergency Cases

Medical simulation is a technique that creates a situation or environment to allow persons to experience a representation of a real event for the purpose of practice, learning, evaluation, testing or to gain understanding of systems or human actions Non-technical skills in pediatric simulation are the skills of communication, leadership, teamwork, situational awareness, decision-making, resource management, safe practice, adverse event minimization, and professionalism, also known as teamwork skills. Mindfulness is the self-regulation of attention with an attitude of curiosity, openness and acceptance. Executive functions include a collection of interrelated functions that are responsible for purposeful, goal-directed, problem-solving behavior. In this project, the investigators aim to check whether features of mindfulness and executive functions can be used to predict teamwork skills of medical students during repeated high-fidelity simulations in emergency pediatric care.

The project will include simulation center in Bialystok, Poland. The investigators will conduct this project over a time of 2 years. Team project is made up of 5 persons, including psychologist, simulation instructors and pediatricians. Participants will be students of medical faculty in medical university. The investigators expect to include at least 340 students in the study which will result in 180 assessed as main or second leaders in repeated simulations. Team project will assess the students during high-fidelity pediatric emergency simulations.

Methods of assessment of medical students during pediatric emergency simulations: features of mindfulness (Mindful Attention Awareness Scale), assessment of executive functions (The Behavior Rating Inventory of Executive Functions - Adult), non-technical skills (Ottawa Crisis Resource Management scale & checklist), technical skills (checklists) and stress. The researchers first will examine association between mindfulness or executive functions and demographic variables. And finally team project will assess the possibility of prediction of non-technical performance level during medical simulations with the use of mindfulness and executive functions assessment.

In general the investigators anticipate that the results of the study will lead to the better understanding of mechanisms that influence non-technical skills in medical students during pediatric emergency cases.

Study Overview

Status

Completed

Conditions

Detailed Description

Research Project Objectives / Research Hypothesis High-fidelity simulation is an effective tool in creating psychological reality of pediatric emergency care. Non-technical skills play a pivotal role in management of life-threatening cases in children. Mindfulness is the self-regulation of attention with an attitude of curiosity, openness and acceptance. It is possible that mindfulness could enhance medical students' capacity for focused attention and concentration by increasing present moment awareness. On the other hand executive functions include a collection of interrelated functions that are responsible for purposeful, goal-directed, problem-solving behavior. It is likely that mindfulness and executive functions and their relationship are important players in emergency cases. Repeated simulations could be a crucial tool for stress management and improving skills in high-fidelity scenarios. In this project, the investigators aim to define whether features of mindfulness and executive functions can be used to predict non-technical skills of medical students during repeated high-fidelity simulations in emergency pediatric care. The researchers hypothesize that: 1) being mindful improves the performance during simulation 2) better executive functions result in better non-technical skills of medical student 3) repeated simulations will reduce stress and influence performance during scenarios 4) there are some potential correlations between executive functions and mindfulness 5) it is possible to predict non-technical performance with the assessment of mindfulness and executive functions of students during pediatric emergency cases.

Research project methodology This is a multi-center, investigator-initiated prospective study. The project will include simulation center in Poland (Medical University in Białystok). The researchers will conduct this project over a time of 2 years. Team project is made up of 5 persons, including psychologist, simulation instructors and pediatricians. Participants will be students of medical faculty in medical university. Methods: First, to increase the awareness of scientific community of the area of interest, the scientists will prepare and publish the review of the current literature in the field of mindfulness, executive functions and emergency medicine. Then, the researchers will adapt six high-fidelity scenarios in the field of pediatric emergency for the requirements of the project. The team project expect to include at least 340 students in the study which will result in 180 assessed as main or second leaders in repeated simulations. For the accomplishment of the aims of this study researchers will need: high-fidelity simulation rooms = emergency rooms with full medical equipment, high-fidelity simulators, audio-video systems for recording and playing scenarios, ECG Holters, debriefing rooms, computers and software. All above mentioned equipment is available in simulation centers and the investigators have the professional staff experienced in high-fidelity simulation and assessment of non-technical skills in medical students. Demographic features will be assessed in all participants: age, sex, year of medical faculty, medical school. The history of previous high-fidelity simulations in participating students will be collected. Methods of assessment of medical students during pediatric emergency simulations: features of mindfulness (Mindful Attention Awareness Scale), assessment of executive functions (The Behavior Rating Inventory of Executive Functions - Adult), non-technical skills (Ottawa Crisis Resource Management scale & checklist), technical skills (checklists) and stress (heart rate, heart rate variability with Holter ECG, blood pressure, Stress-O-Meter and the State-Trait-Anxiety Inventory). Data analysis strategy: The study team will first examine association between mindfulness or executive functions and demographic variables (gender, age, university). Then the researchers are going to construct the regression model to explain the variability of features included in Ottawa scale. And finally the study team will assess the possibility of prediction of non-technical performance level during medical simulations with the use of mindfulness and executive functions assessment.

Expected impact of the research project on the development of science To date more than 150 students were enrolled for the preliminary research. The preliminary results showed that: in the first simulation the students' non-technical performance is weak, one of the main problems in non-technical skills is the fixation error and it is more frequent in simulations with two cases at one time, in the repeated simulations non-technical skills are improving, there is a growing interest in mindfulness training among medical students, technical skills depend of theoretical introduction and students' preparation for the classes, concerning stress the statistically significant increase in heart rate but not blood pressure in students after each simulation was observed . These data clearly show that the proposed study concept is a promising line of basic investigation with solid potential for defining a predictive link between mindfulness, executive function and non-technical skills of medical students during pediatric emergency simulations. In general the investigators anticipate that the results of the present study will lead to the better understanding of mechanisms that influence non-technical skills in medical students during pediatric emergency cases. In the future this research will be used for an overall improvement in team performance at emergency events, which will ultimately translate into a subsequent reduction in the rate of errors and adverse events in medicine. The team leaders also hope that an increased awareness of non-technical skills in the emergency setting among medical students will have an indirect beneficial effect on those skills in the day-to-day setting.

The scientific results of the project will include: review manuscript and at least two original manuscripts, all published in Journals with Impact Factor ≥ 3, presentations on two international meetings in Europe.

Study Type

Observational

Enrollment (Actual)

600

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

    • Podlaskie
      • Białystok, Podlaskie, Poland, 15-029
        • Medical University of Bialystok

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

Ages Eligible for Study

23 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Students of medical faculty (6th year) at the Medical University of Bialystok

Description

Inclusion Criteria:

  • student of 6th Year of medical faculty
  • informed consent

Exclusion Criteria:

  • pregnancy

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

Cohorts and Interventions

Group / Cohort
medical student of 6th Year
Students of medical faculty of 6th Year in Medical University of Bialystok, Poland.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-technical skills - Ottawa scale
Time Frame: 12 months
We have chosen Ottawa Ottawa Crisis Resource Management Global Rating Scale to evaluate performance during our simulations. The following criteria will be evaluated: leadership skills (stays calm and in control during crisis, prompt and firm decision-making, maintains global perspective - "big picture"), situational awareness (avoids fixation error, reassesses and re-evaluates situation constantly, anticipates likely events), communication skills (communicates clearly and concisely, uses directed verbal /non-verbal communication, listens to team input), problem solving (organized and efficient problem solving approach, quick in implementation, considers alternatives during crisis), resource utilization (calls for help appropriately, utilizes resources at hand appropriately, prioritizes tasks appropriately). Each category is measured on a seven-point anchored ordinal scale with descriptive anchors. The higher values represent a better outcome.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical skills
Time Frame: 12 months

Technical skills of medical students during high-fidelity simulations. We designed and validated a scale for assessment technical skills in each scenarios. An example is presented below. The higher values represent a better outcome.

An example of newly developed technical skills checklist for the use in this project - topic - "Ketoacidosis"

Action:

  • History - including polydypsia (1 point), polyuria (1 point), weight loss (1 point)
  • Physical examination: breathing, pulse, blood pressure, saturation, heart and lung auscultation, abdomen, dehydration
  • Treatment:

    • Hydratation 0.9%NaCl i.v.1000ml / first hour (1 point)
    • Insulin (rapid acting, 0.1Units/kg) iv (1 point)
    • Potassium (15%KCl 10-20mmol) (1 point)
    • No addition of Natrium carbonicum (1 point)
12 months

Collaborators and Investigators

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

Investigators

  • Study Chair: Wlodzimierz Luczynski, Prof, Medical University of Bialystok

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 1, 2018

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

November 19, 2018

First Submitted That Met QC Criteria

November 29, 2018

First Posted (Actual)

December 3, 2018

Study Record Updates

Last Update Posted (Actual)

July 17, 2020

Last Update Submitted That Met QC Criteria

July 16, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • N/ST/ZB/18/002/1206

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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