- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05083871
Cognitive Appraisals and Team Performance Under Stress in Simulated Trauma Care
April 5, 2025 updated by: Azienda Usl di Bologna
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
136
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bologna, Italy, 40100
- Azienda Unità Sanitaria Locale
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
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
Description
Inclusion Criteria:
- Learners of the European Trauma Course in Italy
Exclusion Criteria:
- Age < 18 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Learners of the European Trauma Course
Learners attending the European Trauma Course
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
participants' perceptions of task demands vs. personal resources
Time Frame: 3 days
|
Evaluation of the evolution of the participants' perceptions of task demands vs. personal resources throughout the course
|
3 days
|
|
mental readiness
Time Frame: 3 days
|
Evaluation of the evolution of the participants' mental readiness throughout the course
|
3 days
|
|
Social identity
Time Frame: 3 days
|
Evaluation of the evolution of the participants' social identity throughout the course
|
3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Tomaka 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.
- Blascovich 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.
- Turner 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.
- Vine 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.
- Carenzo 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.
- Mendes 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.
- Franc 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 20, 2021
Primary Completion (Actual)
November 30, 2024
Study Completion (Actual)
November 30, 2024
Study Registration Dates
First Submitted
October 6, 2021
First Submitted That Met QC Criteria
October 6, 2021
First Posted (Actual)
October 19, 2021
Study Record Updates
Last Update Posted (Actual)
April 8, 2025
Last Update Submitted That Met QC Criteria
April 5, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 798-2021-OSS-AUSLBO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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