- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02926599
Potential Optimization Training in Simulation. (TOP)
High Fidelity Simulation Performance After a Potential Optimization Training for Anesthesiologist Resident: a Randomized Controlled Trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators aim to compare the individual and team performances for resident who were taught personal optimization skills (positive reinforcement, personalized psycho-physiological relaxation, mental rehearsal) and those who didn't.
The investigators are going to compare groups of anesthesiology residents going through same scenarios of simulated critical events in high fidelity simulation session. Scenarios will be recorded to be analyzed by 2 reviewers independently. A specific checklist of appropriate treatment and a non technical skill checklist will be use to cote team performance (OTTAWA and TEAM scales). Stress of the participants will be assessed by visual analogic scale of participants anxiety and stress. The two groups will be compare to see if improvement in team performance is associated with the intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rhône-Alpes
-
Lyon, Rhône-Alpes, France, 69007
- CLESS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Anesthesiology and Intensive care resident in the simulation education curriculum
Exclusion Criteria:
- Refusal to participate (written approval required)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Personal Optimization Training
Personal Optimization Training such as positive reinforcement, personalized psycho-physiological relaxation and mental rehearsal (total 5 hours a few weeks before the simulation). Having 2 min to focus on techniques they were trained, after briefing of the scenario and before the start of the scenario. |
|
No Intervention: Control
No particular training. Screening of normal labs results during 2 min, after briefing of the scenario and before the start of the scenario. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Performance during simulation
Time Frame: day 1
|
Performance will be assessed by the sum of 3 assessment: Ottawa non technical skill scale, team scanle and specific technical skill scale Total will be a number from 0 to 100.
|
day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
visual analogic scale of anxiety
Time Frame: day 1
|
Visual analogic scales of anxiety
|
day 1
|
Visual analogic scales of confidence
Time Frame: day 1
|
Visual analogic scales of confidence
|
day 1
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
psychometric POMS scales
Time Frame: day 1
|
psychometric POMS scales
|
day 1
|
psychometric STAI scales
Time Frame: day 1
|
psychometric STAI scales
|
day 1
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Jean-Jacques, Lehot, PHD, CLESS
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TOPCLESS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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