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

NCT ID: NCT02424890

Last Updated: 2016-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stress

Study Groups

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Repetitive Sim Group

9 simulation sessions

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

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

Control Group

3 simulation sessions

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel A GHAZALI, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Poitiers

Locations

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GHAZALI

Poitiers, , France

Site Status

Countries

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France

References

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Ghazali DA, Breque C, Sosner P, Lesbordes M, Chavagnat JJ, Ragot S, Oriot D. Stress response in the daily lives of simulation repeaters. A randomized controlled trial assessing stress evolution over one year of repetitive immersive simulations. PLoS One. 2019 Jul 25;14(7):e0220111. doi: 10.1371/journal.pone.0220111. eCollection 2019.

Reference Type DERIVED
PMID: 31344077 (View on PubMed)

Ghazali DA, Darmian-Rafei I, Ragot S, Oriot D. Performance Under Stress Conditions During Multidisciplinary Team Immersive Pediatric Simulations. Pediatr Crit Care Med. 2018 Jun;19(6):e270-e278. doi: 10.1097/PCC.0000000000001473.

Reference Type DERIVED
PMID: 29432402 (View on PubMed)

Ghazali DA, Ragot S, Breque C, Guechi Y, Boureau-Voultoury A, Petitpas F, Oriot D. Randomized controlled trial of multidisciplinary team stress and performance in immersive simulation for management of infant in shock: study protocol. Scand J Trauma Resusc Emerg Med. 2016 Mar 25;24:36. doi: 10.1186/s13049-016-0229-0.

Reference Type DERIVED
PMID: 27012938 (View on PubMed)

Other Identifiers

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Sim-stress.1

Identifier Type: -

Identifier Source: org_study_id

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