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

Stress Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02424890
• Other study ID #: Sim-stress.1
• Status: Completed
• Phase: N/A
• First received: March 19, 2015
• Last updated: October 12, 2016
• Start date: August 2013

Study information

• Verified date: October 2016
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Stress

Intervention

Other:
• MDT 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

Locations

Country	Name	City	State
France	GHAZALI	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salivary Cortisol (SC) during high-fidelity simulation as measure of biological stress response		1 year
Primary	Electrophysiological stress response profile made up of: Heart Rate (HR), Blood Pressure (BP), and Holter parameters (PNN50, HF/BH) during high-fidelity simulation		1 year
Primary	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		1 year
Secondary	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
Secondary	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
Secondary	Effect of repetitive simulation sessions on stress response profile made up of: SC, HR, BP, PNN50, HF/BH, STAI, IES-R, PCLS		1 year