- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06954519
Impact of Mental Imagery on the Non-technical Skills of Anaesthesia Residents
Impact of Mental Imagery of Cognitive Neonatal Resuscitation Aid Compared to Simple Reading on the Non-technical Skills of Anaesthesia Residents Six Months After Initial Training: a Randomized Study
The goal of this randomized trial is to learn if mental imagery works to improve non technical skills in residents. It will also learn about knowledge and technical skills. The main questions it aims to answer are:
Does mental imagery of a cognitive aid improve non technical skills of residents ? Does mental imagery of a cognitive aid improve technical skills and knowledge of residents ?
The invastigators will compare repeated mental imagery to repeated simple reading of a cognitive aid to see if mental imagery works to train non technical skills.
Participants will:
- participate in an initial training on neonatal resuscitation
- be randomized in two groups: mental imagery or simple reading
- Repeat training according to the group with predefined intervalls during 6 months
- be evaluated 6 months after the initial training
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Non-technical skills, such as stress management, decision-making, communication and leadership, are crucial in anaesthesia and intensive care, particularly in emergency situations where technical performance alone is not enough. Mental imagery training used in the fields of sport and surgery could play a key role in improving these skills in future doctors.
A recent study showed that mental imagery training led to better non-technical skills among first-year anaesthesia residents in simulation of a cardiopulmonary resuscitation case (article currently being reviewed).
This study compared mentalisation with reminders at predefined intervals in the intervention group with no reminders to read the cognitive aid in the control group. In addition, cardiopulmonary arrest is a well-known subject for students and initial knowledge was not assessed beforehand.
This new clinical trial aims to evaluate the impact of mental imagery on the non-technical skills of anaesthesia and intensive care residents following initial training in neonatal resuscitation with a full-scale simulation evaluation at 6 months, in residents with a reminder of mentalisation or rereading of the cognitive aid depending on the group.
Objective of the study 2.1 Main objective: Blind video assessment by an expert examiner of the non-technical skills (situational awareness, communication, decision-making, teamwork) of anaesthesia and intensive care residents on a simulated neonatal resuscitation case with the BARS score out of 36 points (9 for the 4 subcategories of non-technical skills).
2.2 Secondary objectives: Assessment of basic knowledge using an initial knowledge quiz, to be repeated after 6 months.
Blind video assessment of technical skills by an expert examiner using the NRPE score.
Assessment of participants' visuospatial abilities using the MIQ-R questionnaire, initially and after 6 months.
Methodology 2.1 Study population Interns in anaesthesia and intensive care (DESAR 1, 2, 3 and 4)
Number of subjects required:
Assuming a change in the BARS score from 20 (control) to 25 (mentalisation) in line with our previous study, a standard deviation of 4, a risk alpha 5% beta 80% and 0 lost to follow-up, 22 participants (11 per group) are required.
Randomisation:
- Experimental group: mentalisation of the ILCOR cognitive aid for neonatal resuscitation at predefined intervals
- Control group: simple reading of the ILCOR cognitive aid for neonatal resuscitation at predefined intervals 2.2 Inclusion criteria Anaesthesia and intensive care interns (DESAR 1, 2, 3 and 4) volunteers Signed informed consent 2.3 Exclusion criteria Refusal to participate in the study 2.4 Intervention
- Both groups will complete an initial knowledge questionnaire and the MIQR questionnaire, then receive initial neonatal resuscitation training based on a theoretical course followed by practical workshops and simulation.
- The experimental group will receive guided mentalisation based on ILCOR cognitive aids for neonatal resuscitation. Regular reminders of mentalisation will be given over a period of 6 months before the final evaluation. Adherence to mental rehearsals will be verified.
- The control group will receive ILCOR cognitive aids for neonatal resuscitation. Regular reminders to read the cognitive aid will be given over a period of 6 months before the final evaluation. Adherence to the reminders will be verified.
- Statistical analysis Mann-Whitney U test for independent samples Statistical analyses performed using SPSS software. Significance level set at p < 0.05
- Ethical considerations Informed consent obtained from all participants, guaranteeing their right to confidentiality and anonymity.
Study schedule 27 March: randomisation and inclusion of participants in two groups. 27 March: knowledge questionnaire and MIQR, theory lesson with presentation of cognitive aid, handling of equipment, MCE, IOT, guided mentalisation for the mentalisation group.
April-October: reminder messages at predefined intervals for both groups October: final evaluation in individual simulation over a 10-minute period, filmed, scenario to be defined, knowledge questionnaire and MIQR. Evaluation of the videos by 2 experts not involved in the study.
- Conclusion The objective of this study is to analyse whether regular training using mental imagery can improve the non-technical skills of anaesthesia and intensive care interns compared to reading a cognitive aid, and thus potentially increase the effectiveness of medical teams in emergency situations.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Daphné Michelet, Professor
- Phone Number: +33 0326782537
- Email: dmichelet@chu-reims.fr
Study Locations
-
-
-
Reims, France, 51100
- Recruiting
- CHU de Reims
-
Contact:
- Daphné Michelet, Professor
- Phone Number: +33 326788485
- Email: dmichelet@chu-reims.fr
-
-
Grand Est
-
Reims, Grand Est, France, 51100
- Enrolling by invitation
- CHU de Reims
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Anesthesia residents in 1, 2, 3 o 4 year of training and volunteers
Exclusion Criteria:
- Residents not volunteer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mental Imagery
Participant of the mental imagery group will have a specific training during the initial training and will repeat the mental imagery regularely during the 6 months (timing of repetition guided by messages sended by investigator)
|
The principle of guided mental imagery and helping students to mentally represent the key stages of a process, using an animated slideshow full of evocative elements, which we created specifically for this study.
The mental imagery will be repeated by the students several times independently until the evaluation simulation at 6 months based on reminders via messages from investigators.
|
|
Active Comparator: Classical reading
Participant of the control group will have no specific training during the initial training, only presentation of the cognitive aid.
They will also repeat the reading of the cognitive aid regularely during the 6 months (timing of repetition guided by messages sended by investigator)
|
Participants of the control group will only read the cognitive aid on neonatal resuscitation at the same intervalls than the experimentation group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Behaviorally Anchored Rating Scale (BARS)
Time Frame: 6 months
|
Evaluation of Non-Technical Skills of anesthesia residents' (Originally published in Watkins et al., Simul in Healthc 2017).
From 1 to 36 points.
Better score means better skills
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neonatal Resuscitation Performance Evaluation (NRPE) scale
Time Frame: 6 months
|
Score evaluationg the different phases of neonatal resuscitation (A, B, C).
Score on 20 points.
Better score means better management.
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Mental imagery study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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