no Condition is StudiedNCT06954519
Impact of Mental Imagery on the Non-technical Skills of Anaesthesia Residents
A study testing Mental imagery and Cognitive aid reading in people with no Condition is Studied and the Focus of the Study is the Impact of Mental Imagery on Non Technical Skills of Medical Students, run by Reims University hospital at 2 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- no Condition is Studied, the Focus of the Study is the Impact of Mental Imagery on Non Technical Skills of Medical Students
- What is being tested?
- Mental imagery and Cognitive aid reading
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesFrance
- Study dates
- 27 Mar 2025to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Anesthesia residents in 1, 2, 3 o 4 year of training and volunteers
Who cannot join
- Residents not volunteer
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Enrolling by invitation
CHU de Reims
Reims, Grand Est, 51100
- Recruiting
CHU de Reims
Reims, 51100
Daphné Michelet, Professor, +33 326788485, dmichelet@chu-reims.fr
About this study
Official title: 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 ?
Read more
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
Read the 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.
- Conditions
- no Condition is Studied, the Focus of the Study is the Impact of Mental Imagery on Non Technical Skills of Medical Students
- Being tested
- Mental imagery, Cognitive aid reading
- Keywords
- mental imagery, cognitive aid, neonatal resuscitation, simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental imageryOther
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.
Cognitive aid readingOther
Participants of the control group will only read the cognitive aid on neonatal resuscitation at the same intervalls than the experimentation group
| Study group | Role | What they receive |
|---|---|---|
| Mental Imagery | Experimental | 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) Receives: Other: Mental imagery |
| Classical reading | Active comparator | 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) Receives: Other: Cognitive aid reading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behaviorally Anchored Rating Scale (BARS)
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
Measured: 6 months
Secondary outcomes (1)
Neonatal Resuscitation Performance Evaluation (NRPE) scale
Score evaluationg the different phases of neonatal resuscitation (A, B, C). Score on 20 points. Better score means better management.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start27 Mar 2025
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for no Condition is StudiedStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reims University hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelet Daphne, Reims University hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954519
- Sponsor's protocol ID
- Mental imagery study
- Status last verified
- Apr 2025
- First submitted
- 27 Mar 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06954519
- Acronym / sponsor ID
- Mental imagery study
- Conditions
- no Condition is Studied, the Focus of the Study is the Impact of Mental Imagery on Non Technical Skills of Medical Students
- Keywords
- mental imagery, cognitive aid, neonatal resuscitation, simulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Reims University hospitalUniversity, hospital or other
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 1 May 2025 (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 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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mental Imagery | Experimental | Other: Mental imageryParticipant 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) |
| Classical reading | Active comparator | Other: Cognitive aid readingParticipant 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) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Anesthesia residents in 1, 2, 3 o 4 year of training and volunteers
Key exclusion criteria (1 listed)
- Residents not volunteer
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 imageryThe 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. | Other | Mental Imagery |
| Cognitive aid readingParticipants of the control group will only read the cognitive aid on neonatal resuscitation at the same intervalls than the experimentation group | Other | Classical reading |
Primary outcome
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
1 secondary outcome
Neonatal Resuscitation Performance Evaluation (NRPE) scale
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental imagery and Cognitive aid reading in people with no Condition is Studied and the Focus of the Study is the Impact of Mental Imagery on Non Technical Skills of Medical Students, run by Reims University hospital at 2 sites 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: looking for participants now, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daphné Michelet, Professor (+33 0326782537, dmichelet@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behaviorally Anchored Rating Scale (BARS) (time frame: 6 months). 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 1 May 2025.