AnesthesiaNCT04159389
Mental Visualization as a Learning Tool in Anesthesia
A study testing Mental visualization in people with Anesthesia and Medical Education, run by University Grenoble Alps at 1 site in France.
Trial summary
The purpose of this study is to evaluate the benefit of adding mental visualization to a training program in medical education. Undergraduate medical students will be randomized before participating in a training program on airway management during rapid sequence induction. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Medical Education
- What is being tested?
- Mental visualization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jan 2020to 5 Mar 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Undergraduate medical students from the Grenoble Alps university hospital
- From the 2nd to the 6th year
- Volontary
Who cannot join
- /
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Learning Mental Visualization to Improve Performance in Anesthesia: a Randomized Controlled Trial by Simulation
The purpose of this study is to evaluate the benefit of adding mental visualization to a training program in medical education. Undergraduate medical students will be randomized before participating in a training program on airway management during rapid sequence induction. In the control group, participants will receive traditional teaching including theoretical courses and procedural simulation. In the intervention group, in addition to traditional teaching, participants will be trained and encouraged to practice mental visualization. The main outcome will be clinical performance during a standardized high-fidelity simulation of rapid sequence induction assessed using a specific pre-established checklist.
- Conditions
- Anesthesia, Medical Education
- Being tested
- Mental visualization
- Keywords
- airway management, pedagogy, learning process, mental visualization, rapide sequence induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental visualizationOther
Instruction in mental visualization by theoretical lessons and support of practice by audio guide and session of experience sharing.
| Study group | Role | What they receive |
|---|---|---|
| traditional teaching | No intervention | theoretical courses and procedural simulation on airway management during rapid sequence induction |
| Mental visualization | Experimental | traditional teaching completed by mental visualization : theoretical courses and procedural simulation on airway management during rapid sequence induction + mental visualization (theoretical courses, audioguide for individual practice and experience sharing session) Receives: Other: Mental visualization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance for airway management in a standardized high-fidelity simulation of rapid sequence induction.
All simulations will be videotaped and the clinical performance of each participant will be assessed by an independent evaluator using a specific pre-established checklist
Measured: 2 weeks
Secondary outcomes (8)
"Material preparation" score, subpart 1 of the clinical performance grid
All simulations will be videotaped and the score of the subpart "Material preparation" of the clinical performance of each participant will be assessed by an independent evaluator using a specific pre-established checklist
Measured: 2 weeks
"Intubation procedure" score, subpart 2 of the clinical performance grid
All simulations will be videotaped and the score of the subpart "Intubation procedure" of the clinical performance of each participant will be assessed by an independent evaluator using a specific pre-established checklist
Measured: 2 weeks
Physiological stress response : SDNN
Heart rate variability evaluated by SDNN (Standard Deviation Normal to Normal), in miliseconds. Physiological stress response is higher when SDNN is lower.
Measured: 2 weeks
Psychological stress response : Stress-VAS
Stress Visual Analogical Scale, from 0 to 100, psychological stress response is higher when score is higher.
Measured: 2 weeks
Psychological stress response : STAI
STAI (State-Trait Anxiety Inventory), from 20 to 80, psychological stress response is higher when score is higher.
Measured: 2 weeks
Adesion to Mental visualization
Frequency questionnaire for the use of mental visualization, from "0" to ">1 per day". We ask the participant to use it once a day
Measured: 2 weeks
Quality to Mental visualization : MIQ
Mental Imagery Questionnaire, from 8 to 56, mental visualisation is better when score is higher.
Measured: 2 weeks
Memorization of key messages at three months
Specific pre-established checklist : 5-point grid. Assessed by an independent evaluator using a phone call.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start6 Jan 2020
- Primary completion5 Dec 2021
- Study completion5 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Grenoble Alps
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre ALBALADEJO, University Grenoble Alps
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159389
- Sponsor's protocol ID
- CESAR002
- Status last verified
- Nov 2023
- First submitted
- 26 Oct 2019
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Mental Visualization to Improve Performance in Anesthesia: a Randomized Controlled Trial by Simulation
- ClinicalTrials.gov ID
- NCT04159389
- Acronym / sponsor ID
- CESAR002
- Conditions
- Anesthesia, Medical Education
- Keywords
- airway management, pedagogy, learning process, mental visualization, rapide sequence induction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Grenoble AlpsUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 5 Dec 2021 (actual)
- Study completion
- 5 Mar 2022 (actual)
- First posted
- 12 Nov 2019 (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.
The purpose of this study is to evaluate the benefit of adding mental visualization to a training program in medical education. Undergraduate medical students will be randomized before participating in a training program on airway management during rapid sequence induction. In the control group, participants will receive traditional teaching including theoretical courses and procedural simulation. In the intervention group, in addition to traditional teaching, participants will be trained and encouraged to practice mental visualization. The main outcome will be clinical performance during a standardized high-fidelity simulation of rapid sequence induction assessed using a specific pre-established checklist.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional teaching | No intervention | –theoretical courses and procedural simulation on airway management during rapid sequence induction |
| Mental visualization | Experimental | Other: Mental visualizationtraditional teaching completed by mental visualization : theoretical courses and procedural simulation on airway management during rapid sequence induction + mental visualization (theoretical courses, audioguide for individual practice and experience sharing session) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Undergraduate medical students from the Grenoble Alps university hospital
- From the 2nd to the 6th year
- Volontary
Key exclusion criteria (1 listed)
- /
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 |
|---|---|---|
| Mental visualizationInstruction in mental visualization by theoretical lessons and support of practice by audio guide and session of experience sharing. | Other | Mental visualization |
Primary outcome
Clinical performance for airway management in a standardized high-fidelity simulation of rapid sequence induction.
Time frame: 2 weeks
All simulations will be videotaped and the clinical performance of each participant will be assessed by an independent evaluator using a specific pre-established checklist
8 secondary outcomes
"Material preparation" score, subpart 1 of the clinical performance grid
Time frame: 2 weeks
"Intubation procedure" score, subpart 2 of the clinical performance grid
Time frame: 2 weeks
Physiological stress response : SDNN
Time frame: 2 weeks
Psychological stress response : Stress-VAS
Time frame: 2 weeks
Psychological stress response : STAI
Time frame: 2 weeks
Adesion to Mental visualization
Time frame: 2 weeks
Quality to Mental visualization : MIQ
Time frame: 2 weeks
Memorization of key messages at three months
Time frame: 3 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 29 Nov 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental visualization in people with Anesthesia and Medical Education, run by University Grenoble Alps 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 3 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 29 Nov 2023. 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?
Clinical performance for airway management in a standardized high-fidelity simulation of rapid sequence induction. (time frame: 2 weeks). 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 29 Nov 2023.