- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07340086
Mobilization of Emotions and Empathy During Communication Training in Nursing Students (AEI-Sim)
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.
Study Overview
Status
Detailed Description
In this observational, longitudinal study, fourth-year nursing students (Pontifical Catholic University of Argentina - Pontificia Universidad Católica Argentina, Buenos Aires) attended a curricular six-hour SBW divided into three sessions. In Session 1, students discussed the SPIKE protocol for communication of bad news, and a clinical case, completing a baseline Positive and Negative Affect Schedule (PANAS). In Session 2, students performed role-plays with simulated patients (SPs), immediately after which the students registered their emotional reflections (ER), completing the Jefferson Scale of Empathy for Health Professionals (JSE-HP), the Jefferson Scale of Patient Perceptions of Physician Empathy (JSPPPE) adapted for nursing communication and repeated PANAS; instructors and SPs also completed JSPPPE. In Session 3, students participated in debriefing and repeated ER, JSE-HP and JSPPPE.
PANAS is a mood scale with 20 items, 10 positive (PA) and 10 negative (NA). High PA means "enthusiastic and motivated"; low PA means "lethargic and sad." High NA means "angry and disgusted"; low NA means "calm and serene." JSE-HP is a 20-item empathy scale for healthcare settings. It measures how well a healthcare professional understands and communicates a patient's perspective. The 7-point Likert scale ranges from 20 to 140.
JSPPE is a 5-item patient-completed empathy scale for healthcare professionals. It uses a 1-to-7 Likert scale to assess understanding, concern, and perspective-taking. Max score: 35 points.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Buenos Aires, Argentina
- Pontifical Catholic University of Argentina
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Nursing students of the 4th year
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes of emotions after the simulation-based workshop on communication of bad news
Time Frame: The PANAS score was completed after sessions 1 (baseline, day 0), 2 (simulation, 1 week after day 0), and 3 (debriefing, 2 weeks after day 0). Baseline day: August 1, 2025. Session 2: August 8, 2025. Session 3: August 15, 2025.
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Questionnaires from the PANAS were completed by the participants.
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The PANAS score was completed after sessions 1 (baseline, day 0), 2 (simulation, 1 week after day 0), and 3 (debriefing, 2 weeks after day 0). Baseline day: August 1, 2025. Session 2: August 8, 2025. Session 3: August 15, 2025.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes of empathy during a simulation-based workshop on communication of bad news measured by Jefferson Scale of Empathy.
Time Frame: Students completed the JSE questionnaire after sessions two and three of the three-stage, simulation-based workshop on communicating bad news. Session two took place on August 8, 2025, and session three took place on August 15, 2025.
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Participants recorded their changes by filling out the Health Professions Version of the Jefferson Scale of Empathy (JSE), which was adapted for nursing communication.
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Students completed the JSE questionnaire after sessions two and three of the three-stage, simulation-based workshop on communicating bad news. Session two took place on August 8, 2025, and session three took place on August 15, 2025.
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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 (August 8 and 15, 2025), of the three-stage, simulation-based workshop on communicating bad news.
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Self-perceived empathy was scored during the communication of bad news using the Jefferson Scale of Patient Perceptions of Physician Empathy (JSPPPE).
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Complete the JSPPPE after sessions two and three, or the simulation and debriefing days (August 8 and 15, 2025), of the three-stage, simulation-based workshop on communicating bad news.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes in self-perceived emotions while executing the simulation-based workshop on communication of bad news
Time Frame: Records were taken after Session 2 (Simulation Day, August 8, 2025) and Session 3 (Debriefing Day, August 15, 2025).
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Participants recorded their self-perceived emotions (emotional reflections) by writing about their feelings, emotions, and sensations in a logbook.
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Records were taken after Session 2 (Simulation Day, August 8, 2025) and Session 3 (Debriefing Day, August 15, 2025).
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Matteo Martinato, PhD, University of Padova
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AEI-Sim-2025-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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