Clinical trial NCT06906614: Psychophysiological Stress Response in Medical Students During Simulation-Based Communication Training -Study Protocol
Official title: Analysis of Predictors of Stress Reactions in Medical Students During Simulation-Based Training
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stress
Keywords: Medical Student Stress
Simulation-Based Training
Psychological Predictors of Stress
Physiological Stress Responses
Heart Rate Variability (HRV)
Patient Communication Skills
Resilience and Self-Efficacy
High-Fidelity Simulation
Stress Management in Medical Education
Psychometric Assessments in Training
Lead sponsor: Masaryk University
Sponsor class: OTHER
Collaborators: name: Simulation Centre of the Faculty of Medicine of Masaryk University
name: Department of Simulation Medicine, Faculty of Medicine, Masaryk University
First posted: 2025-04-02
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of 3rd-year medical students at the Faculty of Medicine, Masaryk University, enrolled in the Medical Psychology and Psychosomatics course. These students will participate in simulation-based communication training involving high-fidelity patient interactions with live actors. The focus is on assessing psychological and physiological stress responses to emotionally challenging patient scenarios, aiming to identify key predictors of stress and improve future training interventions.

Brief summary: In this study, researchers will examine key predictors of stress reactions in medical students participating in simulation-based communication training. By using psychometric questionnaires and physiological measurements, the study will assess how psychological traits, resilience, and self-efficacy impact stress responses during simulated patient interactions. These simulations use live actors to portray emotionally challenging scenarios, such as communicating with anxious or aggressive patients. The results aim to identify factors that contribute to heightened stress, ultimately guiding the development of targeted stress-management strategies to improve students' readiness for real-world clinical settings.

Detailed description: Aims of the Study and Main Hypotheses

The primary aim of the study is to identify key predictors of stress responses in third-year medical students during simulation-based communication training. In this context, "stress" is operationalized both through continuous physiological measurements-principally heart rate variability (HRV) recorded via Polar chest bands-and through a battery of psychometric assessments. The study is designed to evaluate:

Primary Aim:

To determine the predictive value of psychological traits (e.g., resilience, self-efficacy) on physiological stress markers (e.g., HRV stability) and subjective stress ratings during high-fidelity patient interactions with live actors.

Hypothesis: Students exhibiting higher levels of resilience and self-efficacy will demonstrate lower physiological stress responses (i.e., more stable HRV) and report lower subjective stress.

Comparison of Stressors Across Scenarios:

To examine whether different simulated patient interactions-such as those involving anxious, aggressive, silent, or emotionally distressed patients-elicit distinct stress responses. This component will allow for the evaluation of scenario-specific stress effects, which could have implications for tailoring simulation training.

Influence of Personality Traits:

To investigate how personality characteristics, particularly neuroticism and extraversion, influence the magnitude of stress responses during simulations. This analysis will provide insight into the extent to which individual differences moderate stress levels.

Practical Application:

To inform the development of targeted interventions, such as tailored stress management or coping programs, specifically designed for students who are identified as being highly reactive to stress during simulations.

Study Design and Methodology

The study employs an observational cohort design. Data will be collected from third-year medical students enrolled in the Medical Psychology and Psychosomatics course, who participate in simulation-based patient interactions. The detailed methodological framework is as follows:

Data Collection Phases:

Phase 1 (Baseline): Two days prior to simulation sessions, participants will complete a comprehensive set of psychometric questionnaires to assess baseline levels of stress, anxiety, resilience, and self-efficacy.

Phase 2 (Pre-Simulation): Immediately before the simulation begins, students will fill out a pre-simulation questionnaire aimed at capturing their immediate stress and anxiety levels.

Phase 3 (Post-Simulation): Directly after the simulation, a post-simulation questionnaire will be administered to record acute stress responses.

Phase 4 (Post-Debriefing): Following the debriefing session, students will complete a final set of questionnaires to assess any changes in stress levels after reflective processing.

Physiological Monitoring:

Throughout the simulation, continuous HRV data will be collected using Polar chest bands. These devices provide objective, high-resolution data on the autonomic responses of students during live interactions with standardized patients.

Additionally, each simulation session will be supplemented by observational assessments provided by trained actors (standardized patients), focusing on indicators such as body language, communication style, and overall stress manifestation.

Outcome Measures While the primary outcomes relate to physiological markers (HRV) and subjective stress ratings, secondary outcomes will explore the moderating effects of personality traits and the impact of different scenario types on stress responses. These outcomes will serve as predictors for tailoring future simulation-based interventions, ensuring that the training environment can be optimized to both challenge students and support their learning effectively.

Eligibility criteria: Inclusion Criteria

* Enrollment as a 3rd-year medical student at the Faculty of Medicine, Masaryk University.
* Participation in the Medical Psychology and Psychosomatics course.
* Active involvement in simulation-based communication training sessions.
* Signed informed consent provided before the start of the study.
* Willingness to wear physiological monitoring devices (e.g., chest strap) during simulations.

Exclusion Criteria

* Inability or unwillingness to complete all phases of data collection, including pre- and post-simulation assessments.
* Absence of a smartphone with Bluetooth connectivity.

Primary outcomes:
measure: Change in heart rate variability (HRV) using HR band Polar H10
timeFrame: 2,5 hours during each simulation
measure: State-Trait Anxiety Inventory X-II
timeFrame: 2 days before first simulation
measure: Affective Circumplex
timeFrame: 5 minutes before the simulation
measure: NASA Task Load Index (NASA-TLX)
timeFrame: 5 minutes after the simulation
Secondary outcomes:
measure: Toronto Empathy Questionnaire
timeFrame: 2 days before first simulation
measure: The Brief Resilience Scale
timeFrame: 2 days before first simulation
measure: General Self-Efficacy Scale (GSE)
timeFrame: 2 days before first simulation
measure: Perceived Stress Scale (PSS)
timeFrame: 2 days before first simulation
measure: The Big Five Inventory-10 (BFI-10)
timeFrame: 2 days before first simulation
measure: Rosenberg Self-Evaluation Scale (RSES)
timeFrame: 2 days before first simulation
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: Faculty of Medicine, Masaryk University
state: Bohunice
Study officials:
References:
citation: Dunton H, Leng O, Catlow J, Hancock J, Metcalf J. Stress and heart rate in high-fidelity training scenarios for undergraduate medical students. Future Hosp J. 2016 Jun 1;3(Suppl 2):s16. doi: 10.7861/futurehosp.3-2s-s16. No abstract available.
citation: Peabody JE, Ryznar R, Ziesmann MT, Gillman L. A Systematic Review of Heart Rate Variability as a Measure of Stress in Medical Professionals. Cureus. 2023 Jan 29;15(1):e34345. doi: 10.7759/cureus.34345. eCollection 2023 Jan.
citation: van Dulmen S, Tromp F, Grosfeld F, ten Cate O, Bensing J. The impact of assessing simulated bad news consultations on medical students' stress response and communication performance. Psychoneuroendocrinology. 2007 Sep-Nov;32(8-10):943-50. doi: 10.1016/j.psyneuen.2007.06.016. Epub 2007 Aug 6.