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

Mindfulness Clinical Trial

— MindExSim  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03761355
• Other study ID #: N/ST/ZB/18/002/1206
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2020
• Source: Medical University of Bialystok
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 23 Years to 25 Years

Eligibility

Inclusion Criteria:

• student of 6th Year of medical faculty

• informed consent

Exclusion Criteria:

• pregnancy

Related Conditions & MeSH terms

• Mindfulness

Locations

Country	Name	City	State
Poland	Medical University of Bialystok	Bialystok	Podlaskie

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Bialystok

Country where clinical trial is conducted

Poland, 

References & Publications (5)

Botha E, Gwin T, Purpora C. The effectiveness of mindfulness based programs in reducing stress experienced by nurses in adult hospital settings: a systematic review of quantitative evidence protocol. JBI Database System Rev Implement Rep. 2015 Oct;13(10):21-9. doi: 10.11124/jbisrir-2015-2380. — View Citation

Eppich WJ, Brannen M, Hunt EA. Team training: implications for emergency and critical care pediatrics. Curr Opin Pediatr. 2008 Jun;20(3):255-60. doi: 10.1097/MOP.0b013e3282ffb3f3. Review. — View Citation

Greeson JM, Toohey MJ, Pearce MJ. An adapted, four-week mind-body skills group for medical students: reducing stress, increasing mindfulness, and enhancing self-care. Explore (NY). 2015 May-Jun;11(3):186-92. doi: 10.1016/j.explore.2015.02.003. Epub 2015 Feb 16. — View Citation

Jirativanont T, Raksamani K, Aroonpruksakul N, Apidechakul P, Suraseranivongse S. Validity evidence of non-technical skills assessment instruments in simulated anaesthesia crisis management. Anaesth Intensive Care. 2017 Jul;45(4):469-475. — View Citation

Kim J, Neilipovitz D, Cardinal P, Chiu M. A comparison of global rating scale and checklist scores in the validation of an evaluation tool to assess performance in the resuscitation of critically ill patients during simulated emergencies (abbreviated as "CRM simulator study IB"). Simul Healthc. 2009 Spring;4(1):6-16. doi: 10.1097/SIH.0b013e3181880472. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-technical skills - Ottawa scale	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	Technical skills	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