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ISRCTN
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ISRCTN03408765
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DOI
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10.1186/ISRCTN03408765
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Coping with complicated situations: mental practice and simulator training to improve performance in adverse situations
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Scientific title
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Coping with complicated situations: mental practice and simulator training to improve performance in adverse situations: a randomized trial
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Mental practice aimed at teaching crucial operative steps of a complex minimally invasive surgical procedure will improve surgical performance and also lead to a decrease in stress levels experienced by the surgeon. This in turn will improve the surgeons’ ability to maintain a competent level of communication, leadership and decision-making during a critical scenario and which will ultimately result in better team functioning during a crisis scenario.
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Lay summary
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Background and study aims
All surgical procedures require practice. Learning curves have been described for a variety of operations. In order to increase patient safety, changes in the approach to training surgeons have been suggested and in part implemented. Today the possibility of training outside the operating room in simulation facilities exists. Similar to systems used in aviation, surgeons can practice operations with the help of operation 'simulators'. Unfortunately, the availability of these simulation facilities remains low due to the high costs associated with the equipment. As a response, 'mental practice', a novel method for skills training has been investigated as an addition to training outside of the operating room. Mental practice is the mental rehearsal of a task without actual physical movement. It has been shown to improve performance in motor skill in many different fields such as music and sports. It has also been shown to improve the performance of surgeons in the operating room for simple operations. Apart from technical skill improvement, it has been shown that using mental practice reduces stress levels experienced by junior surgeons. Stress is known to have negative effects on memory, communication and concentration which can lead to medical errors and increase the risk for the patient. Therefore, training aimed at reducing stress for the surgeon has the potential to increase patient safety.
Who can participate?
Surgical trainees (junior doctors).
What does the study involve?
Two groups will be created. One group will undergo surgical training using lectures, expert seminars and videos. The other group will additionally be trained using the method of mental practice which they will also continue to do independently at home. This involves mentally rehearsing the operation, going through the operation step by step and visualizing the operation. After one week we will assess the skill of each junior surgeon in our simulation operating room. Here we will allow the surgeons to perform an operation on a simulator dummy and assess their operative skill. We will also create a crisis situation during the simulation and will then evaluate how well the trainee performs during this stressful situation. Furthermore, we will evaluate how much overall stress the individual surgeon experiences during the simulated operation as well as how well the surgeon can communicate with the operating room team during the crisis situation.
What are the possible benefits and risks of participating?
All participants will receive an additional teaching session regarding the procedure to be performed. Residents who are randomized to the control group will have an opportunity to receive the mental practice training once the study is completed if they wish to do so. Information obtained from this study may benefit resident teaching in the future.
By taking part in this study there are no risks of physical injury or harm. Elevated levels of anxiety may be experienced during the simulation scenario but this will be comparable to what is encountered in real life crisis situations in the medical profession.
Where is the study run from?
Allan Waters Family Simulation Centre at St. Michael’s Hospital. All evaluations will be performed in the simulation facility.
When is the study starting and how long is it expected to run for?
The study will start in December 2011 and will run for 4 months or until the required number of 18 surgical trainees have been recruited and evaluated.
Who is funding the study?
Allan Waters Family Simulation Centre at St. Michael’s Hospital (University of Toronto).
Who is the main contact?
Dr Teodor Grantcharov
GrantcharovT@smh.ca
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Ethics approval
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Not provided at time of registration
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Study design
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Prospective randomized single blinded trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Reducing stress and improving surgical performance
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Participants - inclusion criteria
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General surgery residents at the post-graduate year (PGY-3) level or above
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Participants - exclusion criteria
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1. Participants with systemic illness leading to an alteration of blood pressure or heart rate such as hypertension, diabetes mellitus or affective disorders
2. Usage of prescription drugs modifying cardiovascular response
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Anticipated start date
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01/12/2011
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Anticipated end date
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01/06/2012
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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18
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Interventions
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The intervention group will be instructed to apply a mental practice protocol for a complex laparoscopic procedure for surgical training, whereas the control group will undergo only conventional surgical education.
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Primary outcome measure(s)
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Difference in routine surgical performance (OSATS) between the mental imagery trained and untrained residents
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Secondary outcome measure(s)
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1. Baseline surgeon stress levels during the simulation
2. Acute stress reaction
3. Overall subjective stress level after the simulation
4. Differences in Non-Technical Skills (NOTECHS) scores
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Sources of funding
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Allan Waters Family Simulation Centre (Canada)
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Trial website
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Publications
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Contact name
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Dr
Teodor
Grantcharov
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Address
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30 Bond Street
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City/town
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Toronto
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Zip/Postcode
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M5B1W8
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Country
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Canada
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Sponsor
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Allan Waters Family Patient Simulation Centre (Canada)
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Address
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c/o Dr Teodor Grantcharov
30 Bond Street
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City/town
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Toronto
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Zip/Postcode
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ON M5B1W8
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Country
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Canada
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Sponsor website:
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http://www.stmichaelshospital.com/education/simulation.php
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Date applied
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21/10/2011
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Last edited
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08/03/2013
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Date ISRCTN assigned
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16/01/2012
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