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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05083871
Other study ID # 798-2021-OSS-AUSLBO
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 20, 2021
Est. completion date December 31, 2025

Study information

Verified date April 2024
Source Azienda Usl di Bologna
Contact Lorenzo Gamberini, MD
Phone +393403550540
Email l.gamberini@118er.it
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 130
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Learners of the European Trauma Course in Italy Exclusion Criteria: - Age < 18 years

Study Design


Intervention

Other:
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

Locations

Country Name City State
Italy Azienda Unità Sanitaria Locale Bologna

Sponsors (4)

Lead Sponsor Collaborator
Azienda Usl di Bologna Azienda Sanitaria Universitaria Friuli Centrale, Humanitas Clinical and Research Center, Manchester Metropolitan University

Country where clinical trial is conducted

Italy, 

References & Publications (8)

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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):3 — View Citation

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 P — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Performance in simulated emergency trauma care Composite outcome measure taking into account both technical and non technical skills evaluation from the course instructors 3 days
Secondary 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 3 days
Secondary mental readiness Evaluation of the evolution of the participants' mental readiness throughout the course 3 days
Secondary Social identity Evaluation of the evolution of the participants' social identity throughout the course 3 days
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