NCT05083871

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 19, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

October 20, 2021

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

3.1 years

First QC Date

October 6, 2021

Last Update Submit

April 5, 2025

Conditions

Keywords

Medical simulation, Cognitive appraisal, Stress psychology

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • participants' perceptions of task demands vs. personal resources

    3 days

  • mental readiness

    3 days

  • Social identity

    3 days

Study Arms (1)

Learners of the European Trauma Course

Learners attending the European Trauma Course

Other: European Trauma Course

Interventions

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

Learners of the European Trauma Course

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • Learners of the European Trauma Course in Italy

You may not qualify if:

  • Age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Unità Sanitaria Locale

Bologna, Bologna, 40100, Italy

Location

Related Publications (8)

  • 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.

    PMID: 18211177BACKGROUND
  • 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.

    PMID: 9216079BACKGROUND
  • 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.

    PMID: 10434409BACKGROUND
  • 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.

    PMID: 23966448BACKGROUND
  • 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.

    PMID: 24059821BACKGROUND
  • 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.

    PMID: 32034800BACKGROUND
  • 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.

    PMID: 17958714BACKGROUND
  • 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.

    PMID: 27312510BACKGROUND

Related Links

MeSH Terms

Conditions

Wounds and InjuriesStress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2021

First Posted

October 19, 2021

Study Start

October 20, 2021

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

April 8, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations