Clinical Trial

Simulation on the Enhancement of Clinical Communication Competencies in Nursing Students

Study acronym: SI₂C-Nurse
Not Yet Recruiting
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Summary
Background: Clinical communication is a core competency in nursing practice and is pivotal to the quality, safety, and person-centred delivery of care. Effective communication supports treatment adherence, reduces errors, enhances patient and family satisfaction, and contributes to nurses' professional wellbeing. Despite the acknowledged importance of these skills, nursing students frequently report difficulties communicating with confidence and assertiveness in clinical settings. Although simulation is widely regarded as an innovative educational approach, evidence regarding its specific impact on the development of clinical communication skills-and on students' self-perceived communication competence-during the early stages of nursing education remains limited. Methods: This protocol describes a parallel-group randomised controlled trial with 1:1 allocation, to be conducted at a private higher education institution in Portugal. First-year undergraduate nursing students enrolling for the first time in the Helping Relationship course unit will be eligible. The intervention group will participate in clinical simulation sessions, whereas the control group will receive conventional teaching comprising role-play, group discussion, and case analysis. Both groups will complete 10 contact hours delivered across three sessions over the semester. The primary outcomes will be: (a) clinical communication competence, assessed using the Interpersonal Communication Assessment Scale (ICAS), and (b) perceived self-efficacy, measured with the Self-Efficacy Questionnaire (SE-12), both administered pre- and post-intervention. Satisfaction with the educational experience will be assessed as a secondary outcome. Analyses will follow the intention-to-treat principle, complemented by a per-protocol analysis. Discussion: This study will help to clarify whether clinical simulation is superior to conventional teaching in fostering communication skills and students' self-perceived communication competence during the early stages of undergraduate nursing education. The findings may support the early integration of simulation within nursing curricula and inform the design of educational interventions that promote the development of professionals who are more competent and confident in clinical communication, with a direct impact on the quality and safety of care delivery.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2028-06-30 -> 2030-06-30 2026-07-29
minor Completion pushed: 2028-06-30 -> 2030-08-30 2026-07-29
Trial Details
NCT Number NCT07415057
Lead Sponsor Escola Superior de Saúde Norte da Cruz Vermelha Portuguesa
Conditions Communication
Enrollment 50 participants
Start Date 2027-02-01
Primary Completion 2030-06-30 (estimated)
Study Completion 2030-08-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-28