Education NursingAEI-SimNCT07340086
Mobilization of Emotions and Empathy During Communication Training in Nursing Students
An observational study of Education Nursing and Communication Skills, run by University of Padova.
Trial summary
Effective communication in healthcare is vital for patient satisfaction, safety, outcomes, and ethical practice, supporting shared decision-making and informed consent. Simulation-based training is widely used to strengthen communication skills and foster empathy through emotionally engaging experiences. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Education Nursing, Communication Skills, Ethics Education
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2027to 1 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Advanced students from nursing or other healthcare professions who conduct a simulation-based workshop as part of their communication training curriculum.
Who may be able to join
- Advanced students of healthcare professions.
Who cannot join
- None
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
LENIN DE JANON-QUEVEDO. MD, MBE, PhD Student contact
About this study
Official title: Assessment of Emotional and Empathic Involvement During Simulation-Based Communication Training in Nursing Students
Effective communication in healthcare is vital for patient satisfaction, safety, outcomes, and ethical practice, supporting shared decision-making and informed consent. Simulation-based training is widely used to strengthen communication skills and foster empathy through emotionally engaging experiences.
This is a pilot study aimed (1) to assess changes in emotional state and empathy in nursing students after a simulation-based workshop (SBW) on delivering bad news, and (2) to evaluate the sensitivity of standardized scales in detecting these changes.
Read the detailed description
This observational, longitudinal, descriptive study will be conducted among advanced nursing students participating in a six-hour Simulation-Based Workshop (SBW) comprising three sessions. In Session 1, students will discuss the SPIKES protocol for communicating bad news and analyze a clinical case. Baseline affective states will be assessed using the Positive and Negative Affect Schedule (PANAS). In Session 2, students will participate in role-plays with simulated patients (SPs). Immediately following the role-plays, students will record their emotional reflections (ER) and complete the Jefferson Scale of Empathy for Health Professionals (JSE-HP), the Jefferson Scale of Patient Perceptions of Physician Empathy (JSPPPE), adapted to assess healthcare professional communication, and the PANAS. Instructors and SPs will also complete the adapted JSPPPE to evaluate students' empathic communication. In Session 3, students will participate in a structured debriefing, after which ER, JSE-HP, and JSPPPE will be reassessed.
The PANAS will be used to assess affective states through 20 items comprising 10 positive-affect (PA) and 10 negative-affect (NA) items. Higher PA scores will indicate greater levels of enthusiasm and motivation, whereas lower scores will reflect reduced energy and sadness. Higher NA scores will indicate greater negative affect, including feelings of anger and disgust, while lower scores will reflect calmer and more serene emotional states.
The JSE-HP will be used to assess empathy in healthcare professionals, particularly their ability to understand and communicate patients' perspectives. The instrument comprises 20 items rated on a 7-point Likert scale, yielding total scores ranging from 20 to 140, with higher scores indicating a greater empathic orientation.
The JSPPPE will be used to assess perceptions of healthcare professionals' empathic communication. The five-item instrument will be rated on a 7-point Likert scale and will assess dimensions including understanding, concern, and perspective-taking. Total scores will range from 5 to 35, with higher scores indicating greater perceived empathy.
- Conditions
- Education Nursing, Communication Skills, Ethics Education, Empathy, Simulation Based Learning
- Keywords
- Nursing, Education, Communication skills, Simulation, Ethics, Empathy
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of emotions after the simulation-based workshop on communication of bad news
Questionnaires from the PANAS will be completed by the participants.
Measured: PANAS scores will be assessed at three time points: after Session 1 (baseline; Day 0), Session 2 (simulation; Day 7), and Session 3 (debriefing; Day 14), scheduled for April 1 (Day 0), 8 (session 2), and 15 (session 3), 2027, respectively.
Secondary outcomes (2)
Changes of empathy during a simulation-based workshop on communication of bad news measured by Jefferson Scale of Empathy.
Participants will assess changes in their conceptualizations of empathy by completing the Health Professions Version of the Jefferson Scale of Empathy (JSE-HP).
Measured: Students will complete the JSE-HP questionnaire after sessions two (S2) and three (S3) of the three-stage, simulation-based workshop on communicating bad news. S2 is planed to take place on April 8, 2027, and S3 on April 15, 2027.
Changes of perceived empathy after participating in a simulation-based workshop on communication of bad news measured by Jefferson Scale of Patient Perceptions of Physician Empathy
Self-perceived empathy will be scored during the communication of bad news using the Jefferson Scale of Patient Perceptions of Physician Empathy (JSPPPE).
Measured: Complete the JSPPPE after sessions two and three, or the simulation and debriefing days (April 8 and 15, 2027 respectively), of the three-stage, simulation-based workshop on communicating bad news.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start1 Apr 2027 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Education NursingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matteo Martinato, PhD, Study director, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07340086
- Sponsor's protocol ID
- AEI-Sim-2025-01
- Acronym
- AEI-Sim
- Status last verified
- Sep 2026
- First submitted
- 16 Dec 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Emotional and Empathic Involvement During Simulation-Based Communication Training in Nursing Students
- ClinicalTrials.gov ID
- NCT07340086
- Acronym / sponsor ID
- AEI-Sim / AEI-Sim-2025-01
- Conditions
- Education Nursing, Communication Skills, Ethics Education, Empathy, Simulation Based Learning
- Keywords
- Nursing, Education, Communication skills, Simulation, Ethics, Empathy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 1 Apr 2027 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effective communication in healthcare is vital for patient satisfaction, safety, outcomes, and ethical practice, supporting shared decision-making and informed consent. Simulation-based training is widely used to strengthen communication skills and foster empathy through emotionally engaging experiences.
This is a pilot study aimed (1) to assess changes in emotional state and empathy in nursing students after a simulation-based workshop (SBW) on delivering bad news, and (2) to evaluate the sensitivity of standardized scales in detecting these changes.
Detailed description
This observational, longitudinal, descriptive study will be conducted among advanced nursing students participating in a six-hour Simulation-Based Workshop (SBW) comprising three sessions. In Session 1, students will discuss the SPIKES protocol for communicating bad news and analyze a clinical case. Baseline affective states will be assessed using the Positive and Negative Affect Schedule (PANAS). In Session 2, students will participate in role-plays with simulated patients (SPs). Immediately following the role-plays, students will record their emotional reflections (ER) and complete the Jefferson Scale of Empathy for Health Professionals (JSE-HP), the Jefferson Scale of Patient Perceptions of Physician Empathy (JSPPPE), adapted to assess healthcare professional communication, and the PANAS. Instructors and SPs will also complete the adapted JSPPPE to evaluate students' empathic communication. In Session 3, students will participate in a structured debriefing, after which ER, JSE-HP, and JSPPPE will be reassessed.
The PANAS will be used to assess affective states through 20 items comprising 10 positive-affect (PA) and 10 negative-affect (NA) items. Higher PA scores will indicate greater levels of enthusiasm and motivation, whereas lower scores will reflect reduced energy and sadness. Higher NA scores will indicate greater negative affect, including feelings of anger and disgust, while lower scores will reflect calmer and more serene emotional states.
The JSE-HP will be used to assess empathy in healthcare professionals, particularly their ability to understand and communicate patients' perspectives. The instrument comprises 20 items rated on a 7-point Likert scale, yielding total scores ranging from 20 to 140, with higher scores indicating a greater empathic orientation.
The JSPPPE will be used to assess perceptions of healthcare professionals' empathic communication. The five-item instrument will be rated on a 7-point Likert scale and will assess dimensions including understanding, concern, and perspective-taking. Total scores will range from 5 to 35, with higher scores indicating greater perceived empathy.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Advanced students from nursing or other healthcare professions who conduct a simulation-based workshop as part of their communication training curriculum.
Key inclusion criteria (1 listed)
- Advanced students of healthcare professions.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes of emotions after the simulation-based workshop on communication of bad news
Time frame: PANAS scores will be assessed at three time points: after Session 1 (baseline; Day 0), Session 2 (simulation; Day 7), and Session 3 (debriefing; Day 14), scheduled for April 1 (Day 0), 8 (session 2), and 15 (session 3), 2027, respectively.
Questionnaires from the PANAS will be completed by the participants.
2 secondary outcomes
Changes of empathy during a simulation-based workshop on communication of bad news measured by Jefferson Scale of Empathy.
Time frame: Students will complete the JSE-HP questionnaire after sessions two (S2) and three (S3) of the three-stage, simulation-based workshop on communicating bad news. S2 is planed to take place on April 8, 2027, and S3 on April 15, 2027.
Changes of perceived empathy after participating in a simulation-based workshop on communication of bad news measured by Jefferson Scale of Patient Perceptions of Physician Empathy
Time frame: Complete the JSPPPE after sessions two and three, or the simulation and debriefing days (April 8 and 15, 2027 respectively), of the three-stage, simulation-based workshop on communicating bad news.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
LENIN DE JANON-QUEVEDO. MD, MBE, PhD Student contact
Matteo Martinato, PhD study director
University of Padova
Questions about this trial
What is this clinical trial studying?
An observational study of Education Nursing and Communication Skills, run by University of Padova.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LENIN DE JANON-QUEVEDO. MD, MBE, PhD Student (+5491150064678, lenin.dejanonquevedo@studenti.unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of emotions after the simulation-based workshop on communication of bad news (time frame: PANAS scores will be assessed at three time points: after Session 1 (baseline; Day 0), Session 2 (simulation; Day 7), and Session 3 (debriefing; Day 14), scheduled for April 1 (Day 0), 8 (session 2), and 15 (session 3), 2027, respectively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.