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NCT Number: NCT06906614

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

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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine, Masaryk University

Brno, Bohunice, 62500, Czechia

Location contact

Miroslav Světlák, PhD

CONTACT

[email protected]

549491372

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 2,5 hours during each simulation

    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. State-Trait Anxiety Inventory X-II

    Time frame: 2 days before first simulation

    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.

  3. Affective Circumplex

    Time frame: 5 minutes before the simulation

    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".

  4. NASA Task Load Index (NASA-TLX)

    Time frame: 5 minutes after the simulation

    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.

Secondary outcomes

  1. Toronto Empathy Questionnaire

    Time frame: 2 days before first simulation

    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. The Brief Resilience Scale

    Time frame: 2 days before first simulation

    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.

  3. General Self-Efficacy Scale (GSE)

    Time frame: 2 days before first simulation

    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.

  4. Perceived Stress Scale (PSS)

    Time frame: 2 days before first simulation

    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.

  5. The Big Five Inventory-10 (BFI-10)

    Time frame: 2 days before first simulation

    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.

  6. Rosenberg Self-Evaluation Scale (RSES)

    Time frame: 2 days before first simulation

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Miroslav Světlák, PhD

CONTACT

[email protected]

+420 549 49 1372

Veronika Kamenská, Ing.

CONTACT

[email protected]

+420608335578

Sponsors and collaborators

Lead sponsor

Masaryk University

Other

Collaborators

  • Department of Simulation Medicine, Faculty of Medicine, Masaryk University
  • Simulation Centre of the Faculty of Medicine of Masaryk University

Registry information

Official study title

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

Acronym: SIMU2025

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 2, 2025
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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