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NCT Number: NCT07427641

Effect of Visual Deprivation of the Team Leader on Team Performance During Simulated Medical Emergencies

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.

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Key information

Conditions

High Fidelity Simulation Training Competency Based Education Education, Medical Education, Medical, Continuing Randomized Controlled Trials Teaching Innovation

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

The teams participating in the simulation sessions are composed as follows:

  • A senior doctor identified as the "medical leader"
  • An anaesthesia and intensive care intern
  • A state-registered nurse anaesthetist

Inclusion criteria

  • Participants with at least two years' experience in the specialty.

a. 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.

Exclusion criteria

  • The study cannot be carried out during a safety rest period (i.e. the day after being on call).

Treatment and study plan

Visual deprivation

Behavioral

The designated team leader performs the simulated scenario while wearing visual deprivation mask

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

    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.

  2. 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

    the change in the score for items 1 and 2 of the TEAM grid obtained by the medical leader of each team

  3. Clinical transferability of soft skills training in clinical practice

    Time frame: Immediately after the intervention at day 1 and at 3 month

    self-assessment questionnaire on perceived transfer to clinical practice and an open-ended narrative question completed individually by study participants.

  4. Evolution of theoretical knowledge of soft skills

    Time frame: At the end of the intervention at day 1 and at 3 month

    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

  5. Assessment of anxiety induced by the intervention

    Time frame: At the end of the intervention at day 1

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas LEBOUVIER, M.D.

CONTACT

[email protected]

33 (0)2 99 28 24 22

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

LEADE ME: Effect of Visual Deprivation of the Team Leader on Team Performance During Simulated Medical Emergencies - A Multicenter Randomized Controlled Study

Acronym: LEAD ME

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 23, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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