NCT07427641

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress32%
Feb 2026Apr 2027

Study Start

First participant enrolled

February 2, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

March 31, 2026

Status Verified

February 1, 2026

Enrollment Period

1.2 years

First QC Date

February 6, 2026

Last Update Submit

March 30, 2026

Conditions

High Fidelity Simulation TrainingRandomized Controlled TrialsEducation, Medical, ContinuingEducation, MedicalTeaching InnovationCompetency Based Education

Outcome Measures

Primary Outcomes (1)

  • 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)

    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

    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

    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

    Immediately after the intervention at day 1 and at 3 month

  • Evolution of theoretical knowledge of soft skills

    At the end of the intervention at day 1 and at 3 month

  • Assessment of anxiety induced by the intervention

    At the end of the intervention at day 1

Study Arms (2)

Visual deprivation

EXPERIMENTAL

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

Behavioral: Visual deprivation

No visual deprivation

NO INTERVENTION

Control group leaders perform the scenario without visual deprivation.

Interventions

Visual deprivationBEHAVIORAL

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

Visual deprivation

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rennes University Hospital

Rennes, 35000, France

RECRUITING

Central Study Contacts

Thomas LEBOUVIER, M.D.

CONTACT

33 (0)2 99 28 24 22thomas.lebouvier@chu-rennes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2026

First Posted

February 23, 2026

Study Start

February 2, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

March 31, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Available after the publication of the report and for 5 years after the publication date.
Access Criteria
The data will be shared with other researchers under the cover of a research project and a plan of the planned analyses submitted to the corresponding author. A data sharing agreement will be signed between the study sponsor and the researchers who wish to access the data.

Locations

FR(1)