- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04159389
Mental Visualization as a Learning Tool in Anesthesia
November 28, 2023 updated by: Pierre ALBALADEJO, University Grenoble Alps
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
La Tronche, France, 38700
- University Grenoble Alps
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Undergraduate medical students from the Grenoble Alps university hospital
- From the 2nd to the 6th year
- Volontary
Exclusion Criteria:
- /
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: traditional teaching
theoretical courses and procedural simulation on airway management during rapid sequence induction
|
|
Experimental: Mental visualization
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)
|
Instruction in mental visualization by theoretical lessons and support of practice by audio guide and session of experience sharing.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
"Material preparation" score, subpart 1 of the clinical performance grid
Time Frame: 2 weeks
|
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
|
2 weeks
|
"Intubation procedure" score, subpart 2 of the clinical performance grid
Time Frame: 2 weeks
|
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
|
2 weeks
|
Physiological stress response : SDNN
Time Frame: 2 weeks
|
Heart rate variability evaluated by SDNN (Standard Deviation Normal to Normal), in miliseconds.
Physiological stress response is higher when SDNN is lower.
|
2 weeks
|
Psychological stress response : Stress-VAS
Time Frame: 2 weeks
|
Stress Visual Analogical Scale, from 0 to 100, psychological stress response is higher when score is higher.
|
2 weeks
|
Psychological stress response : STAI
Time Frame: 2 weeks
|
STAI (State-Trait Anxiety Inventory), from 20 to 80, psychological stress response is higher when score is higher.
|
2 weeks
|
Adesion to Mental visualization
Time Frame: 2 weeks
|
Frequency questionnaire for the use of mental visualization, from "0" to ">1 per day".
We ask the participant to use it once a day
|
2 weeks
|
Quality to Mental visualization : MIQ
Time Frame: 2 weeks
|
Mental Imagery Questionnaire, from 8 to 56, mental visualisation is better when score is higher.
|
2 weeks
|
Memorization of key messages at three months
Time Frame: 3 months
|
Specific pre-established checklist : 5-point grid.
Assessed by an independent evaluator using a phone call.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 6, 2020
Primary Completion (Actual)
December 5, 2021
Study Completion (Actual)
March 5, 2022
Study Registration Dates
First Submitted
October 26, 2019
First Submitted That Met QC Criteria
November 7, 2019
First Posted (Actual)
November 12, 2019
Study Record Updates
Last Update Posted (Actual)
November 29, 2023
Last Update Submitted That Met QC Criteria
November 28, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- CESAR002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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