High Fidelity Simulation TrainingLEAD MENCT07427641
Effect of Visual Deprivation of the Team Leader on Team Performance During Simulated Medical Emergencies
A study testing Visual deprivation in people with High Fidelity Simulation Training and Randomized Controlled Trials, run by Rennes University Hospital at 1 site in France.
Trial summary
This multicenter randomized controlled study aims to evaluate the impact of temporary visual deprivation of the medical team leader on non-technical skills and team performance during high-fidelity simulated medical emergencies. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- High Fidelity Simulation Training, Randomized Controlled Trials, Education, Medical, Continuing
- What is being tested?
- Visual deprivation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2026to Apr 2027
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants with at least two years' experience in the specialty.
- For interns, an additional requirement is that they must have completed a semester in intensive care.
- Recruited via simulation trainers at their respective hospitals or university hospitals.
Who cannot join
- The study cannot be carried out during a safety rest period (i.e. the day after being on call).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Rennes University Hospital
Rennes, 35000
Thomas LEBOUVIER, M.D., 33 (0)2 99 28 24 22, thomas.lebouvier@chu-rennes.fr
About this study
Official title: LEADE ME: Effect of Visual Deprivation of the Team Leader on Team Performance During Simulated Medical Emergencies - A Multicenter Randomized Controlled Study
This multicenter randomized controlled study aims to evaluate the impact of temporary visual deprivation of the medical team leader on non-technical skills and team performance during high-fidelity simulated medical emergencies. The intervention is based on principles of crisis resource management and cognitive load theory. Team performance will be assessed using validated scoring tools immediately after the intervention and at three months follow-up.
- Conditions
- High Fidelity Simulation Training, Randomized Controlled Trials, Education, Medical, Continuing, Education, Medical, Teaching Innovation, Competency Based Education
- Being tested
- Visual deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual deprivationBehavioural
The designated team leader performs the simulated scenario while wearing visual deprivation mask
| Study group | Role | What they receive |
|---|---|---|
| Visual deprivation | Experimental | the designated team leader performs the simulated scenario while wearing visual deprivation mask. Receives: Behavioral: Visual deprivation |
| No visual deprivation | No intervention | Control group leaders perform the scenario without visual deprivation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of team performance on non-technicals skills
Team performance on non-technicals skills measured using the validated Team emergency Assessment Measure (TEAM) score assessed by blinded independent evaluators based on video recordings.
TEAM score goes from 0 to 54 : 0 being the lowest level of non-technical competence (worst outcome) and 54 being the highest (better outcome)
Measured: Before intervention (scenario 1) at day 1, immediately after (scenario 3) at day 1 and after the procedure (scenario 4) at 3 month
Secondary outcomes (5)
Evolution of team's clinical performance
Rating with objective markers of quality of care. Five objective and measurable criteria for each scenario are defined by a panel of three experts in anaesthesia and intensive care using the DELPHI method.
Measured: Before intervention (scenario 1) at day 1, immediately after (scenario 3) at day 1 and after the procedure (scenario 4) at 3 month
Evolution of medical leadership skills
the change in the score for items 1 and 2 of the TEAM grid obtained by the medical leader of each team
Measured: Before intervention (scenario 1) at day 1, immediately after (scenario 3) at day 1 and after the procedure (scenario 4) at 3 month
Clinical transferability of soft skills training in clinical practice
self-assessment questionnaire on perceived transfer to clinical practice and an open-ended narrative question completed individually by study participants.
Measured: Immediately after the intervention at day 1 and at 3 month
Evolution of theoretical knowledge of soft skills
scores obtained by participants in the pre- and post-training questionnaires developed for this training course in accordance with the HAS (High Health Authority) recommendations for good practice in health simulation
Measured: At the end of the intervention at day 1 and at 3 month
Assessment of anxiety induced by the intervention
Anxiety is assessed for all participants using a visual analogue scale and the State-Trait Anxiety Inventory-Form Y (STAI-Y) questionnaire.
STAI-Y score ranges from 20 to 80 :
- 20 to 37: low anxiety (better outcome)
- 38 to 44: moderate anxiety
- 44 to 80: high anxiety (worse outcome)
Measured: At the end of the intervention at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start2 Feb 2026
- Primary completion1 Apr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Fidelity Simulation TrainingStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- 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
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427641
- Sponsor's protocol ID
- 35RC25-T4818_LEADME
- Acronym
- LEAD ME
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from participant questionnaires will be provided upon request (subject to anonymity). Video recordings will not be provided, as they will be deleted immediately after analysis by experts, as indicated in the information notice to participants.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LEADE ME: Effect of Visual Deprivation of the Team Leader on Team Performance During Simulated Medical Emergencies - A Multicenter Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07427641
- Acronym / sponsor ID
- LEAD ME / 35RC25-T4818_LEADME
- Conditions
- High Fidelity Simulation Training, Randomized Controlled Trials, Education, Medical, Continuing, Education, Medical, Teaching Innovation, Competency Based Education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 23 Feb 2026 (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.
This multicenter randomized controlled study aims to evaluate the impact of temporary visual deprivation of the medical team leader on non-technical skills and team performance during high-fidelity simulated medical emergencies. The intervention is based on principles of crisis resource management and cognitive load theory. Team performance will be assessed using validated scoring tools immediately after the intervention and at three months follow-up.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visual deprivation | Experimental | Behavioral: Visual deprivationthe designated team leader performs the simulated scenario while wearing visual deprivation mask. |
| No visual deprivation | No intervention | –Control group leaders perform the scenario without visual deprivation. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants with at least two years' experience in the specialty.
- Recruited via simulation trainers at their respective hospitals or university hospitals.
Key exclusion criteria (1 listed)
- The study cannot be carried out during a safety rest period (i.e. the day after being on call).
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 |
|---|---|---|
| Visual deprivationThe designated team leader performs the simulated scenario while wearing visual deprivation mask | Behavioural | Visual deprivation |
Primary outcome
Evolution of team performance on non-technicals skills
Time frame: Before intervention (scenario 1) at day 1, immediately after (scenario 3) at day 1 and after the procedure (scenario 4) at 3 month
Team performance on non-technicals skills measured using the validated Team emergency Assessment Measure (TEAM) score assessed by blinded independent evaluators based on video recordings. TEAM score goes from 0 to 54 : 0 being the lowest level of non-technical competence (worst outcome) and 54 being the highest (better outcome)
5 secondary outcomes
Evolution of team's clinical performance
Time frame: Before intervention (scenario 1) at day 1, immediately after (scenario 3) at day 1 and after the procedure (scenario 4) at 3 month
Evolution of medical leadership skills
Time frame: Before intervention (scenario 1) at day 1, immediately after (scenario 3) at day 1 and after the procedure (scenario 4) at 3 month
Clinical transferability of soft skills training in clinical practice
Time frame: Immediately after the intervention at day 1 and at 3 month
Evolution of theoretical knowledge of soft skills
Time frame: At the end of the intervention at day 1 and at 3 month
Assessment of anxiety induced by the intervention
Time frame: At the end of the intervention at day 1
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 31 Mar 2026.
- Individual participant dataSharing planned: Yes. Data from participant questionnaires will be provided upon request (subject to anonymity). Video recordings will not be provided, as they will be deleted immediately after analysis by experts, as indicated in the information notice to participants.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual deprivation in people with High Fidelity Simulation Training and Randomized Controlled Trials, run by Rennes University Hospital 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: looking for participants now, as of the sponsor's last update on 31 Mar 2026. 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?
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 Thomas LEBOUVIER, M.D. (33 (0)2 99 28 24 22, thomas.lebouvier@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of team performance on non-technicals skills (time frame: Before intervention (scenario 1) at day 1, immediately after (scenario 3) at day 1 and after the procedure (scenario 4) at 3 month). 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 31 Mar 2026.