Psychophysiological Stress Response in Medical Students During Simulation-Based Communication Training -Study Protocol

NCT06906614 | Not Yet Recruiting DMC

• 1 other identifier: SIMU2025
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• Change in heart rate variability (HRV) using HR band Polar H10

  The primary outcome is the change in physiological stress markers, specifically heart rate variability (HRV), measured continuously during each simulation scenario. This measure assesses the immediate physiological response to stress-inducing patient interactions.The obtained data will be processed using time-domain HRV parameters - RMSSD, SDNN, pNN50 and Power Spectrum density HRV parameters - LF power, HF power, and LF/HF ratio.

  2,5 hours during each simulation

• State-Trait Anxiety Inventory X-II

  For measuring anxiety, the State-Trait Anxiety Inventory was used, which assesses both the temporary state of anxiety (state anxiety, STAI X-I) and the long-term trait anxiety (STAI X-II). In this study, the focus was placed on the STAI X-II section, which contains 20 items (items 21 to 40). Respondents rate their answers on a scale from 1 ("almost never") to 4 ("almost always"). During scoring, some items are reverse-scored, and the total score is obtained by summing all responses, with a higher score indicating a higher level of trait anxiety.

  2 days before first simulation

• Affective Circumplex

  The Affective Circumplex is a questionnaire designed to subjectively assess emotions and self-confidence in the context of a simulation. Within this tool, respondents rate their level of competence - between the poles of "I feel competent" (have the knowledge and skills necessary for the simulation) and "I do not feel competent" (do not have the knowledge and skills necessary for the simulation). The questionnaire also includes an assessment of current emotional state, with participants choosing between the poles of "uncomfortable" and "pleasant" and between the poles of "calm" and "upset". Next, respondents rate their sense of control over their emotions, and are asked to express whether they are in control of their emotions or whether they are losing control. Finally, participants are asked to verbally express their current emotion - in one word or a short sentence, for example, "sadness", "shame" or "joy".

  5 minutes before the simulation

• NASA Task Load Index (NASA-TLX)

  The NASA Task Load Index (NASA-TLX) is a tool to subjectively assess cognitive and emotional load during a simulation. Students rate six dimensions: mental and physical demands, time pressure, performance, effort, and frustration. Each dimension is assessed on a scale of 0-100, where a higher value indicates a higher burden. The NASA-TLX total score can be calculated as the average of all dimensions or using weighted scoring. This tool helps to compare students' subjective stress with objective physiological indicators of stress.

  5 minutes after the simulation

Secondary Outcomes (6)

• Toronto Empathy Questionnaire

  2 days before first simulation

• The Brief Resilience Scale

  2 days before first simulation

• General Self-Efficacy Scale (GSE)

  2 days before first simulation

• Perceived Stress Scale (PSS)

  2 days before first simulation

• The Big Five Inventory-10 (BFI-10)

  2 days before first simulation

Study Arms (1)

3rd-Year Medical Students in Simulation Training

This cohort consists of 3rd-year medical students enrolled in the Medical Psychology and Psychosomatics course, participating in simulation-based communication training.

Behavioral: Simulation-Based Communication Training

Interventions

Simulation-Based Communication Training BEHAVIORAL

In our study, the intervention is more of an experimental situation - a scenario. High-fidelity scenarios include patients played by real actors displaying anxiety, aggression, silence, and emotional distress in various clinical situations such as delivering serious news or frustration for waiting for physicians. The average time of each simulation is 12 minutes.

3rd-Year Medical Students in Simulation Training

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Masaryk University: lead
• Simulation Centre of the Faculty of Medicine of Masaryk University: collaborator
• Department of Simulation Medicine, Faculty of Medicine, Masaryk University: collaborator

Study Sites (1)

Faculty of Medicine, Masaryk University

Brno, Bohunice, 62500, Czechia

Location

Related Publications (3)

• 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.

  PMID: 31098245 BACKGROUND

• 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.

  PMID: 36865953 BACKGROUND

• 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.

  PMID: 17689196 BACKGROUND

Central Study Contacts

Miroslav Světlák, PhD

CONTACT

+420 549 49 1372; msvetlak@med.muni.cz

Veronika Kamenská, Ing.

CONTACT

+420608335578; veronika.kamenska@med.muni.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department head (Department of Medical Psychology and Ethics)

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 2, 2025
• Study Start: April 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)