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MindfulnessMindExSimNCT03761355

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

An observational study of Mindfulness, run by Medical University of Bialystok at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 23 to 25 yearsHealthy volunteers can take part
Conditions the study is for
Mindfulness
How many people
600 participants
Where
1 sitePoland
Study dates
1 Oct 2018to 30 Jun 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 23 to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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

Who may be able to join

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

Who cannot join

  • pregnancy

Trial locations and contacts

1 site in 1 country.

Poland1 site
  • Medical University of Bialystok

    Bialystok, Podlaskie Voivodeship, 15-029

Other trials in Poland

About this study

Official title: 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.

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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.

Read the 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.

Conditions
Mindfulness
Keywords
mindfulness, executive functions, medical simulation, medical students, pediatrics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03761355
Study groupRoleWhat they receive
medical student of 6th YearStudents of medical faculty of 6th Year in Medical University of Bialystok, Poland.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

Secondary outcomes (1)
  1. 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)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2018
  2. Study start1 Oct 2018
  3. Primary completion30 Jun 2020
  4. Study completion30 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03761355
Sponsor's protocol ID
N/ST/ZB/18/002/1206
Acronym
MindExSim
Status last verified
Jul 2020
First submitted
19 Nov 2018
Last updated
17 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 18475092
  • 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. doi: 10.1177/0310057X1704500410.

    PubMed 28673217
  • 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.

    PubMed 26571279
  • 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.

    PubMed 25792145
  • 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.

    PubMed 19212245
  • Chmielewski J, Los K, Waszkiewicz N, Luczynski W. Mindfulness Is Related to the Situational Awareness of Medical Students Confronted with Life-Threatening Emergency Situations. J Clin Med. 2021 May 2;10(9):1955. doi: 10.3390/jcm10091955.

    PubMed 34063194
  • Los K, Chmielewski J, Cebula G, Bielecki T, Torres K, Luczynski W. Relationship between mindfulness, stress, and performance in medical students in pediatric emergency simulations. GMS J Med Educ. 2021 Apr 15;38(4):Doc78. doi: 10.3205/zma001474. eCollection 2021.

    PubMed 34056067

Questions about this trial

What is this clinical trial studying?

An observational study of Mindfulness, run by Medical University of Bialystok at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Non-technical skills - Ottawa scale (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03761355, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2020.

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