TraumaNCT05083871
Cognitive Appraisals and Team Performance Under Stress in Simulated Trauma Care
An observational study of Trauma and Stress, Emotional, run by Azienda Usl di Bologna at 1 site in Italy.
Trial summary
Medical teams work in demanding situations that are often uncertain, changeable and require accurate decision-making, skilled movement and coordinated action. How teams perform matters for patient outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Trauma, Stress, Emotional, Cognitive Change
- What is being tested?
- European Trauma Course
- How many people
- 136 participants
- Where
- 1 siteItaly
- Study dates
- 20 Oct 2021to 30 Nov 2024
- Phase
- Observational
- 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
Study population: The study population will include all the learners attending the European Trauma Course in Italy, independently from their previous work experience and educational background
Who may be able to join
- Learners of the European Trauma Course in Italy
Who cannot join
- Age < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Medical teams work in demanding situations that are often uncertain, changeable and require accurate decision-making, skilled movement and coordinated action. How teams perform matters for patient outcomes. In addition to medical expertise, how individuals and the team collectively respond and manage the psychological stress of the situation has a significant impact on performance. One approach, which attempts to explain the facilitating and debilitating effects of stress on performance is the biopsychosocial model of challenge and threat. A challenge state occurs when perceived personal resources meet or exceed the situation's demands, whereas threat occurs when demands exceed resources. Challenge states have been consistently associated with improved performance in a range of environments and activities, including medical settings. In a recent study conducted during a national simulation-based training event for residents (the SIMCUP Italia 2018) it was found that a high level of resources is associated with better performance until demands become very high. The present study builds on previous work to explore how challenge and threat states are linked to performance. It includes a more recently developed and robust measure of demands and resource appraisals. In addition, secondary aims include the exploration of how psychological variables, specifically cognitive anxiety, somatic anxiety, self-confidence and social identity (connection with other members of the medical team) are linked to challenge and threat and performance. Understanding the psychological determinants of performance in critical care can provide the basis for individual and team-based interventions to improve critical care team performance.
- Conditions
- Trauma, Stress, Emotional, Cognitive Change
- Being tested
- European Trauma Course
- Keywords
- Medical simulation, Cognitive appraisal, Stress psychology
- Medical subject headings
- Wounds and Injuries, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
European Trauma CourseOther
Structured learning program specifically focused on Trauma management. The course provides frontal lessons, workshops for the technical skills and simulated scenarios.
Please see https://www.erc.edu/courses/european-trauma-course for additional details
| Study group | Role | What they receive |
|---|---|---|
| Learners of the European Trauma Course | Learners attending the European Trauma Course Receives: Other: European Trauma Course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance in simulated emergency trauma care
Composite outcome measure taking into account both technical and non technical skills evaluation from the course instructors
Measured: 3 days
Secondary outcomes (3)
participants' perceptions of task demands vs. personal resources
Evaluation of the evolution of the participants' perceptions of task demands vs. personal resources throughout the course
Measured: 3 days
mental readiness
Evaluation of the evolution of the participants' mental readiness throughout the course
Measured: 3 days
Social identity
Evaluation of the evolution of the participants' social identity throughout the course
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start20 Oct 2021
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Usl di Bologna
- Sponsor type
- Other government
- Collaborators
- Manchester Metropolitan University, Humanitas Clinical and Research Center, Azienda Sanitaria Universitaria Friuli Centrale
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083871
- Sponsor's protocol ID
- 798-2021-OSS-AUSLBO
- Status last verified
- Apr 2025
- First submitted
- 6 Oct 2021
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mendes WB, Major B, McCoy S, Blascovich J. How attributional ambiguity shapes physiological and emotional responses to social rejection and acceptance. J Pers Soc Psychol. 2008 Feb;94(2):278-91. doi: 10.1037/0022-3514.94.2.278.
PubMed 18211177Tomaka J, Blascovich J, Kibler J, Ernst JM. Cognitive and physiological antecedents of threat and challenge appraisal. J Pers Soc Psychol. 1997 Jul;73(1):63-72. doi: 10.1037//0022-3514.73.1.63.
PubMed 9216079Blascovich J, Mendes WB, Hunter SB, Salomon K. Social "facilitation" as challenge and threat. J Pers Soc Psychol. 1999 Jul;77(1):68-77. doi: 10.1037//0022-3514.77.1.68.
PubMed 10434409Turner MJ, Jones MV, Sheffield D, Slater MJ, Barker JB, Bell JJ. Who thrives under pressure? Predicting the performance of elite academy cricketers using the cardiovascular indicators of challenge and threat states. J Sport Exerc Psychol. 2013 Aug;35(4):387-97. doi: 10.1123/jsep.35.4.387.
PubMed 23966448Vine SJ, Freeman P, Moore LJ, Chandra-Ramanan R, Wilson MR. Evaluating stress as a challenge is associated with superior attentional control and motor skill performance: testing the predictions of the biopsychosocial model of challenge and threat. J Exp Psychol Appl. 2013 Sep;19(3):185-94. doi: 10.1037/a0034106.
PubMed 24059821Carenzo L, Braithwaite EC, Carfagna F, Franc J, Ingrassia PL, Turner MJ, Slater MJ, Jones MV. Cognitive appraisals and team performance under stress: A simulation study. Med Educ. 2020 Mar;54(3):254-263. doi: 10.1111/medu.14050. Epub 2020 Feb 7.
PubMed 32034800Mendes WB, Gray HM, Mendoza-Denton R, Major B, Epel ES. Why egalitarianism might be good for your health: physiological thriving during stressful intergroup encounters. Psychol Sci. 2007 Nov;18(11):991-8. doi: 10.1111/j.1467-9280.2007.02014.x.
PubMed 17958714Franc JM, Verde M, Gallardo AR, Carenzo L, Ingrassia PL. An Italian version of the Ottawa Crisis Resource Management Global Rating Scale: a reliable and valid tool for assessment of simulation performance. Intern Emerg Med. 2017 Aug;12(5):651-656. doi: 10.1007/s11739-016-1486-7. Epub 2016 Jun 16.
PubMed 27312510
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Appraisals and Team Performance Under Stress in Simulated Trauma Care
- ClinicalTrials.gov ID
- NCT05083871
- Acronym / sponsor ID
- 798-2021-OSS-AUSLBO
- Conditions
- Trauma, Stress, Emotional, Cognitive Change
- Keywords
- Medical simulation, Cognitive appraisal, Stress psychology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Azienda Usl di BolognaOther government
- Collaborators
- Manchester Metropolitan University, Humanitas Clinical and Research Center, Azienda Sanitaria Universitaria Friuli Centrale
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 19 Oct 2021 (actual)
- 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.
Medical teams work in demanding situations that are often uncertain, changeable and require accurate decision-making, skilled movement and coordinated action. How teams perform matters for patient outcomes. In addition to medical expertise, how individuals and the team collectively respond and manage the psychological stress of the situation has a significant impact on performance. One approach, which attempts to explain the facilitating and debilitating effects of stress on performance is the biopsychosocial model of challenge and threat. A challenge state occurs when perceived personal resources meet or exceed the situation's demands, whereas threat occurs when demands exceed resources. Challenge states have been consistently associated with improved performance in a range of environments and activities, including medical settings. In a recent study conducted during a national simulation-based training event for residents (the SIMCUP Italia 2018) it was found that a high level of resources is associated with better performance until demands become very high. The present study builds on previous work to explore how challenge and threat states are linked to performance. It includes a more recently developed and robust measure of demands and resource appraisals. In addition, secondary aims include the exploration of how psychological variables, specifically cognitive anxiety, somatic anxiety, self-confidence and social identity (connection with other members of the medical team) are linked to challenge and threat and performance. Understanding the psychological determinants of performance in critical care can provide the basis for individual and team-based interventions to improve critical care team performance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Learners of the European Trauma Course | – | Other: European Trauma CourseLearners attending the European Trauma Course |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include all the learners attending the European Trauma Course in Italy, independently from their previous work experience and educational background
Key inclusion criteria (1 listed)
- Learners of the European Trauma Course in Italy
Key exclusion criteria (1 listed)
- Age < 18 years
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 |
|---|---|---|
| European Trauma CourseStructured learning program specifically focused on Trauma management. The course provides frontal lessons, workshops for the technical skills and simulated scenarios. Please see https://www.erc.edu/courses/european-trauma-course for additional details | Other | Learners of the European Trauma Course |
Primary outcome
Performance in simulated emergency trauma care
Time frame: 3 days
Composite outcome measure taking into account both technical and non technical skills evaluation from the course instructors
3 secondary outcomes
participants' perceptions of task demands vs. personal resources
Time frame: 3 days
mental readiness
Time frame: 3 days
Social identity
Time frame: 3 days
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 8 Apr 2025.
- Results publication: PubMed 18211177Mendes WB, Major B, McCoy S, Blascovich J. How attributional ambiguity shapes physiological and emotional responses to social rejection and acceptance. J Pers Soc Psychol. 2008 Feb;94(2):278-91. doi: 10.1037/0022-3514.94.2.278.
- Results publication: PubMed 9216079Tomaka J, Blascovich J, Kibler J, Ernst JM. Cognitive and physiological antecedents of threat and challenge appraisal. J Pers Soc Psychol. 1997 Jul;73(1):63-72. doi: 10.1037//0022-3514.73.1.63.
- Results publication: PubMed 10434409Blascovich J, Mendes WB, Hunter SB, Salomon K. Social "facilitation" as challenge and threat. J Pers Soc Psychol. 1999 Jul;77(1):68-77. doi: 10.1037//0022-3514.77.1.68.
- Results publication: PubMed 23966448Turner MJ, Jones MV, Sheffield D, Slater MJ, Barker JB, Bell JJ. Who thrives under pressure? Predicting the performance of elite academy cricketers using the cardiovascular indicators of challenge and threat states. J Sport Exerc Psychol. 2013 Aug;35(4):387-97. doi: 10.1123/jsep.35.4.387.
- Results publication: PubMed 24059821Vine SJ, Freeman P, Moore LJ, Chandra-Ramanan R, Wilson MR. Evaluating stress as a challenge is associated with superior attentional control and motor skill performance: testing the predictions of the biopsychosocial model of challenge and threat. J Exp Psychol Appl. 2013 Sep;19(3):185-94. doi: 10.1037/a0034106.
- Results publication: PubMed 32034800Carenzo L, Braithwaite EC, Carfagna F, Franc J, Ingrassia PL, Turner MJ, Slater MJ, Jones MV. Cognitive appraisals and team performance under stress: A simulation study. Med Educ. 2020 Mar;54(3):254-263. doi: 10.1111/medu.14050. Epub 2020 Feb 7.
- Results publication: PubMed 17958714Mendes WB, Gray HM, Mendoza-Denton R, Major B, Epel ES. Why egalitarianism might be good for your health: physiological thriving during stressful intergroup encounters. Psychol Sci. 2007 Nov;18(11):991-8. doi: 10.1111/j.1467-9280.2007.02014.x.
- Results publication: PubMed 27312510Franc JM, Verde M, Gallardo AR, Carenzo L, Ingrassia PL. An Italian version of the Ottawa Crisis Resource Management Global Rating Scale: a reliable and valid tool for assessment of simulation performance. Intern Emerg Med. 2017 Aug;12(5):651-656. doi: 10.1007/s11739-016-1486-7. Epub 2016 Jun 16.
- European Trauma Course official siteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma and Stress, Emotional, run by Azienda Usl di Bologna at 1 site in Italy.
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 1 inclusion and 1 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 8 Apr 2025. 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 Italy. 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?
Performance in simulated emergency trauma care (time frame: 3 days). 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 NCT05083871, which also lists 8 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 8 Apr 2025.