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.
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
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.
Read more
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 group | Role | What they receive |
|---|---|---|
| medical student of 6th Year | Students 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.
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)
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.
- First posted3 Dec 2018
- Study start1 Oct 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for MindfulnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wlodzimierz Luczynski, Prof, Study chair, Medical University of Bialystok
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 18475092Jirativanont 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 28673217Botha 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 26571279Greeson 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 25792145Kim 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 19212245Chmielewski 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 34063194Los 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness and Executive Functions for Prediction of Non-technical Skills of Students in High-fidelity Medical Simulations in Pediatric Emergency Cases
- ClinicalTrials.gov ID
- NCT03761355
- Acronym / sponsor ID
- MindExSim / N/ST/ZB/18/002/1206
- Conditions
- Mindfulness
- Keywords
- mindfulness, executive functions, medical simulation, medical students, pediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 3 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| medical student of 6th Year | – | –Students of medical faculty of 6th Year in Medical University of Bialystok, Poland. |
Who may qualify
- Ages
- 23 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Students of medical faculty (6th year) at the Medical University of Bialystok
Key inclusion criteria (2 listed)
- student of 6th Year of medical faculty
- informed consent
Key exclusion criteria (1 listed)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Technical skills
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Background: PubMed 18475092Eppich 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.
- Background: PubMed 28673217Jirativanont 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.
- Background: PubMed 26571279Botha 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.
- Background: PubMed 25792145Greeson 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.
- Background: PubMed 19212245Kim 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.
- Derived from this study: PubMed 34063194Chmielewski 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.
- Derived from this study: PubMed 34056067Los 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wlodzimierz Luczynski, Prof study chair
Medical University of Bialystok
1 site in 1 country: see every site and its status.
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.