NCT07340086

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
3mo left

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress71%
Aug 2025Aug 2026

Study Start

First participant enrolled

August 1, 2025

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

14 days

First QC Date

December 16, 2025

Last Update Submit

January 16, 2026

Conditions

Keywords

NursingEducationCommunication skillsSimulationEthicsEmpathy

Outcome Measures

Primary Outcomes (1)

  • Changes of emotions after the simulation-based workshop on communication of bad news

    Questionnaires from the PANAS were completed by the participants.

    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.

Secondary Outcomes (2)

  • Changes of empathy during a simulation-based workshop on communication of bad news measured by Jefferson Scale of Empathy.

    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.

  • 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

    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.

Other Outcomes (1)

  • Changes in self-perceived emotions while executing the simulation-based workshop on communication of bad news

    Records were taken after Session 2 (Simulation Day, August 8, 2025) and Session 3 (Debriefing Day, August 15, 2025).

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Fourth-year nursing students who conducted a simulation-based workshop as part of their communication training curriculum.

You may qualify if:

  • Nursing students of the 4th year

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pontifical Catholic University of Argentina

Buenos Aires, Argentina

Location

Study Officials

  • Matteo Martinato, PhD

    University of Padova

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2025

First Posted

January 14, 2026

Study Start

August 1, 2025

Primary Completion

August 15, 2025

Study Completion (Estimated)

August 1, 2026

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations