HealthyTOPNCT02926599
Potential Optimization Training in Simulation.
A study testing Personal Optimization Training in people with Healthy, run by Claude Bernard University at 1 site in France.
Trial summary
Simulated environment allowed safe learning of critical events and knowledge of appropriate response and treatment. Anesthesiology resident education curriculum in Lyon plans several high fidelity simulation session with a large panel of critical events. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Personal Optimization Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2016to Oct 2017
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Anesthesiology and Intensive care resident in the simulation education curriculum
Who cannot join
- Refusal to participate (written approval required)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Fidelity Simulation Performance After a Potential Optimization Training for Anesthesiologist Resident: a Randomized Controlled Trial.
Simulated environment allowed safe learning of critical events and knowledge of appropriate response and treatment. Anesthesiology resident education curriculum in Lyon plans several high fidelity simulation session with a large panel of critical events. Anticipation of critical events before they may occur and planification of team resources and priority in the treatment strategy may help to improve team performance during the scenario. The investigators' goal is to compare individual and team performances with or without an optimization personal potential training.
Read the 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.
- Conditions
- Healthy
- Being tested
- Personal Optimization Training
- Keywords
- High Fidelity Simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal Optimization TrainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Personal Optimization Training | Experimental | 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. Receives: Behavioral: Personal Optimization Training |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Performance during simulation
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.
Measured: day 1
Secondary outcomes (2)
visual analogic scale of anxiety
Visual analogic scales of anxiety
Measured: day 1
Visual analogic scales of confidence
Visual analogic scales of confidence
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claude Bernard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lilot Marc, Claude Bernard University
- Investigators
- Jean-Jacques, Lehot, PHD, Study chair, CLESS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926599
- Sponsor's protocol ID
- TOPCLESS
- Acronym
- TOP
- Status last verified
- Aug 2018
- First submitted
- 30 Sep 2016
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Fidelity Simulation Performance After a Potential Optimization Training for Anesthesiologist Resident: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02926599
- Acronym / sponsor ID
- TOP / TOPCLESS
- Conditions
- Healthy
- Keywords
- High Fidelity Simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Claude Bernard UniversityUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 6 Oct 2016 (estimated)
- 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.
Simulated environment allowed safe learning of critical events and knowledge of appropriate response and treatment. Anesthesiology resident education curriculum in Lyon plans several high fidelity simulation session with a large panel of critical events. Anticipation of critical events before they may occur and planification of team resources and priority in the treatment strategy may help to improve team performance during the scenario. The investigators' goal is to compare individual and team performances with or without an optimization personal potential training.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personal Optimization Training | Experimental | Behavioral: Personal Optimization TrainingPersonal 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. |
| Control | No intervention | –No particular training. Screening of normal labs results during 2 min, after briefing of the scenario and before the start of the scenario. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Anesthesiology and Intensive care resident in the simulation education curriculum
Key exclusion criteria (1 listed)
- Refusal to participate (written approval required)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personal Optimization Training | Behavioural | Personal Optimization Training |
Primary outcome
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.
2 secondary outcomes
visual analogic scale of anxiety
Time frame: day 1
Visual analogic scales of confidence
Time frame: day 1
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 21 Aug 2018.
- 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.
Jean-Jacques, Lehot, PHD study chair
CLESS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personal Optimization Training in people with Healthy, run by Claude Bernard University at 1 site in France.
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 1 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 21 Aug 2018. 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 France. 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?
Performance during simulation (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2018.