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Trial of Multidisciplinary Team Stress and Performance in Immersive Simulation for Management of Infant in Shock

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02424890
Enrollment
48
Registered
2015-04-23
Start date
2013-08-31
Completion date
Unknown
Last updated
2016-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress

Brief summary

The objective of this randomized trial is to study the effect of stress on performance and the effect of repetition of simulation sessions on performance and stress. This study is a randomized controlled trial including 48 participants who composed 12 multidisciplinary teams (MDTs). Each MDT was made up of 4 persons: an emergency physician, a resident, a nurse, and an ambulance driver who usually compose an emergency team of the French Emergency Medical Service (EMS). 6 MDTs underwent 9 simulation sessions over 1 year (Repetitive SIm Group). 6 MDTs underwent 3 simulation sessions over 1 year (Control Group). Evidence of the existence of stress was assessed in 3 ways: salivary cortisol, Holter parameters, and psychological stress questionnaires. The impact of stress on overall team performance, on technical procedure, and on teamwork, is evaluated by specific validated scales. Detection of post-traumatic stress (PTSD) is performed by self-evaluation on the 7th day and after one month. The perspective is to concomitantly evaluate technical and non-technical performance, and the impact of stress on both. This is the first randomized trial studying repetition of simulation sessions and its impact on both clinical performance and stress as explored by objective and subjective assessments. The investigators expect that stress decreases team performance and that repeated simulation increases team performance. The investigators expect no variation of stress parameters regardless of level of performance.

Interventions

OTHERMDT simulation sessions of management of life-threatening events over 1 year

9 simulation sessions over 1 year for Repetitive Sim Group and 3 simulation sessions over 1 year for Control Group

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Multidisciplinary team made up of 4 persons: 1. an emergency physician with less than seven years of experience , 2. a resident, 3. a nurse, 4. and an ambulance driver.

Exclusion criteria

* Past history and/or psychiatric disease that modifies stress response, * Pacemaker or implantable defibrillator, * Treatment with a medication having a potential effect on stress parameters.

Design outcomes

Primary

MeasureTime frame
Salivary Cortisol (SC) during high-fidelity simulation as measure of biological stress response1 year
Electrophysiological stress response profile made up of: Heart Rate (HR), Blood Pressure (BP), and Holter parameters (PNN50, HF/BH) during high-fidelity simulation1 year
Psychological stress response profile made up of: scores on State-Trait Anxiety Inventory (STAI), Impact of Event Scale - Revised (IES-R), Posttraumatic Stress Disorder Checklist Scale (PCLS) questionnaires during high-fidelity simulation1 year

Secondary

MeasureTime frame
Effect of repetitive simulation sessions on non-technical performance profile made up of: scores of Clinical Teamwork Scale (CTS), Behavioural Assessment Tool (BAT)1 year
Effect of repetitive simulation sessions on stress response profile made up of: SC, HR, BP, PNN50, HF/BH, STAI, IES-R, PCLS1 year
Effect of repetitive simulation sessions on technical skills performance profile made up of: scores of Team Average Performance Assessment Scale (TAPAS), IO access performance assessment scale1 year

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026