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

ConditionStress
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMasaryk University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Inability or unwillingness to complete all phases of data collection, including pre- and post-simulation assessments.

Absence of a smartphone with Bluetooth connectivity.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: 3rd-Year Medical Students in Simulation Training1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
2,5 hours during each simulation
2

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.

Time frame
2 days before first simulation
3

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".

Time frame
5 minutes before the simulation
4

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.

Time frame
5 minutes after the simulation

Secondary outcomes

1

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.

Time frame
2 days before first simulation
2

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.

Time frame
2 days before first simulation
3

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.

Time frame
2 days before first simulation
4

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.

Time frame
2 days before first simulation

Other outcomes

Sponsors and contacts

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Masaryk University

Lead sponsor

Simulation Centre of the Faculty of Medicine of Masaryk University

Collaborator

Department of Simulation Medicine, Faculty of Medicine, Masaryk University

Collaborator

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