StressNCT02424890
Trial of Multidisciplinary Team Stress and Performance in Immersive Simulation for Management of Infant in Shock
A study testing MDT simulation sessions of management of life-threatening events over 1 year in people with Stress, run by Poitiers University Hospital at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- MDT simulation sessions of management of life-threatening events over 1 year
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2013to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Multidisciplinary team made up of 4 persons:
- an emergency physician with less than seven years of experience ,
- a resident,
- a nurse,
- and an ambulance driver.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Stress
- Being tested
- MDT simulation sessions of management of life-threatening events over 1 year
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDT simulation sessions of management of life-threatening events over 1 yearOther
9 simulation sessions over 1 year for Repetitive Sim Group and 3 simulation sessions over 1 year for Control Group
| Study group | Role | What they receive |
|---|---|---|
| Repetitive Sim Group | Active comparator | 9 simulation sessions Receives: Other: MDT simulation sessions of management of life-threatening events over 1 year |
| Control Group | Active comparator | 3 simulation sessions Receives: Other: MDT simulation sessions of management of life-threatening events over 1 year |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary Cortisol (SC) during high-fidelity simulation as measure of biological stress response
Measured: 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
Measured: 1 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 simulation
Measured: 1 year
Secondary outcomes (3)
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
Measured: 1 year
Effect of repetitive simulation sessions on non-technical performance profile made up of: scores of Clinical Teamwork Scale (CTS), Behavioural Assessment Tool (BAT)
Measured: 1 year
Effect of repetitive simulation sessions on stress response profile made up of: SC, HR, BP, PNN50, HF/BH, STAI, IES-R, PCLS
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startAug 2013
- Primary completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel A GHAZALI, MD, Principal investigator, Poitiers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424890
- Sponsor's protocol ID
- Sim-stress.1
- Status last verified
- Oct 2016
- First submitted
- 19 Mar 2015
- Last updated
- 13 Oct 2016
- Results posted
- No
Publications
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.
PubMed 31344077Ghazali 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.
PubMed 29432402Ghazali 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.
PubMed 27012938
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Multidisciplinary Team Stress and Performance in Immersive Simulation for Management of Infant in Shock
- ClinicalTrials.gov ID
- NCT02424890
- Acronym / sponsor ID
- Sim-stress.1
- Conditions
- Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Sep 2014 (actual)
- First posted
- 23 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repetitive Sim Group | Active comparator | Other: MDT simulation sessions of management of life-threatening events over 1 year9 simulation sessions |
| Control Group | Active comparator | Other: MDT simulation sessions of management of life-threatening events over 1 year3 simulation sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Multidisciplinary team made up of 4 persons:
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MDT simulation sessions of management of life-threatening events over 1 year9 simulation sessions over 1 year for Repetitive Sim Group and 3 simulation sessions over 1 year for Control Group | Other | Control Group, Repetitive Sim Group |
Primary outcome
Salivary Cortisol (SC) during high-fidelity simulation as measure of biological stress response
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
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
3 secondary outcomes
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
Time frame: 1 year
Effect of repetitive simulation sessions on non-technical performance profile made up of: scores of Clinical Teamwork Scale (CTS), Behavioural Assessment Tool (BAT)
Time frame: 1 year
Effect of repetitive simulation sessions on stress response profile made up of: SC, HR, BP, PNN50, HF/BH, STAI, IES-R, PCLS
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
- Derived from this study: PubMed 31344077Ghazali 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.
- Derived from this study: PubMed 29432402Ghazali 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.
- Derived from this study: PubMed 27012938Ghazali 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel A GHAZALI, MD principal investigator
Poitiers University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MDT simulation sessions of management of life-threatening events over 1 year in people with Stress, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary Cortisol (SC) during high-fidelity simulation as measure of biological stress response (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02424890, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2016.