Psychophysiological Stress Response in Medical Students During Simulation-Based Communication Training -Study Protocol (SIMU2025)

Analysis of Predictors of Stress Reactions in Medical Students During Simulation-Based Training

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stress
• Intervention / Treatment: Behavioral: Simulation-Based Communication Training

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Miroslav Světlák, PhD; Phone Number: +420 549 49 1372; Email: msvetlak@med.muni.cz
• Study Contact Backup: Name: Veronika Kamenská, Ing.; Phone Number: +420608335578; Email: veronika.kamenska@med.muni.cz

Study Locations

• Czech Republic
  • Bohunice
    • Brno, Bohunice, Czech Republic, 62500
      • Faculty of Medicine, Masaryk University
      • Contact: Miroslav Světlák, PhD; Phone Number: 549491372; Email: msvetlak@med.muni.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toronto Empathy Questionnaire	This questionnaire is a shortened version of the original 16-item instrument, with the seven most relevant items (TEQ1, TEQ2, TEQ3, TEQ4, TEQ5, TEQ14 and TEQ16) selected for the study. Respondents answer on a Likert scale, where a value of 0 indicates "never" and a value of 4 indicates "always". The total score is obtained by summing all responses, with reverse scoring for negatively worded items before summing. A higher score indicates a higher level of empathy.	2 days before first simulation
The Brief Resilience Scale	An instrument designed to measure psychological resilience, the ability to recover quickly from difficult or stressful situations. The questionnaire contains 6 items, with respondents rating their answers on a scale from 1 ('strongly disagree') to 5 ('strongly agree'). When scoring, items 1, 3 and 5 are positively worded, while items 2, 4 and 6 are reverse scored. The final score is determined as the average of all responses, with a higher average indicating a higher level of psychological resilience.	2 days before first simulation
General Self-Efficacy Scale (GSE)	This questionnaire measures an individual's general self-confidence in solving problems and coping with challenges. It contains 10 items, all of which are positively worded. Respondents answer on a scale from 1 ("not at all valid") to 4 ("absolutely valid"). A total score is obtained by summing the scores of all responses, and higher final scores correspond to higher perceived self-efficacy.	2 days before first simulation
Perceived Stress Scale (PSS)	The Perceived Stress Scale (PSS) is a classic stress assessment instrument. The questions in this scale ask about feelings and thoughts during the last month. Each question has five response options ranging in value from null to four (0=never; 1=almost never; 2=sometimes; 3=fairly often; 4=very often). To find the total raw score, sum the values of the response to each question (reverse code items 4, 5, 7a and 8). Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.	2 days before first simulation
The Big Five Inventory-10 (BFI-10)	The Big Five Inventory-10 (BFI-10) measures the Big Five personality traits: Extraversion, Agreeableness, Conscientiousness, Emotional Stability, and Openness. Each question has five response options ranging in value from one to five (1= disagree strongly; 2= disagree a little; 3= neither agree or disagree; 4= agree a little; 5= agree strongly). To find the total raw score, sum the values of the response to each question for each of subscale (reverse code items 1,3,4,5 and 7). The lowest possible raw score is 10 and the highest possible raw score is 50. A score ranging from 2-10 is obtained by summing each factor individually. A higher score represents more of the concept being measured.	2 days before first simulation
Rosenberg Self-Evaluation Scale (RSES)	The Rosenberg Self-Evaluation Scale was used to measure the individual's global self-esteem and overall relationship to self. This questionnaire contains 10 items, five of which are worded positively and five negatively. Respondents rate their answers on a scale from 1 ('completely invalid') to 4 ('completely valid'). A total score, indicating the level of self-esteem, is obtained by summing all responses - a higher total score indicates a higher level of self-esteem.	2 days before first simulation

Collaborators and Investigators

• Sponsor: Masaryk University
• Collaborators: Simulation Centre of the Faculty of Medicine of Masaryk University; Department of Simulation Medicine, Faculty of Medicine, Masaryk University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: March 26, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Heart Rate Variability (HRV); Medical Student Stress; Simulation-Based Training; Psychological Predictors of Stress; Physiological Stress Responses; Patient Communication Skills; Resilience and Self-Efficacy; High-Fidelity Simulation; Stress Management in Medical Education; Psychometric Assessments in Training
• Other Study ID Numbers: SIMU2025

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