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Clinical Trials/NCT02424890
NCT02424890
Completed
Not Applicable

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

Poitiers University Hospital1 site in 1 country48 target enrollmentAugust 2013
ConditionsStress

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress
Sponsor
Poitiers University Hospital
Enrollment
48
Locations
1
Primary Endpoint
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 simulation
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2013
End Date
September 2014
Last Updated
9 years ago
Study Type
Interventional
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Multidisciplinary team made up of 4 persons:
  • an emergency physician with less than seven years of experience ,
  • a resident,
  • 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.

Outcomes

Primary Outcomes

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 simulation

Time Frame: 1 year

Electrophysiological stress response profile made up of: Heart Rate (HR), Blood Pressure (BP), and Holter parameters (PNN50, HF/BH) during high-fidelity simulation

Time Frame: 1 year

Salivary Cortisol (SC) during high-fidelity simulation as measure of biological stress response

Time Frame: 1 year

Secondary Outcomes

  • 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, PCLS(1 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 scale(1 year)

Study Sites (1)

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