Simulation on the Enhancement of Clinical Communication Competencies in Nursing Students

NCT07415057 | Not Yet Recruiting

• 1 other identifier: 2025-039
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Communication

Keywords

Communication; Randomized Controlled Trial; Simulation Training; Education, Nursing

Outcome Measures

Primary Outcomes (2)

• Clinical communication competence

  Interpersonal Communication Assessment Scale (ICAS) Clinical communication competence will be assessed using the Interpersonal Communication Assessment Scale (ICAS), Portuguese version, validated for use among nursing students. The primary outcome will be the ICAS total score, reported as a continuous variable (points), with higher scores indicating higher levels of clinical communication competence. Only the total score of the ICAS will be used for outcome reporting. The ICAS is a self-report instrument designed to assess interpersonal communication skills and has demonstrated good psychometric properties in the Portuguese population, including satisfactory internal consistency, construct validity, and reliability. The Portuguese version has shown high internal consistency, with a Cronbach's alpha of 0.939 for the total scale.

  Baseline (prior to the first laboratory-based practical session), immediately after the intervention (at the conclusion of the final laboratory-based practical session), and follow-up at 8 weeks after the intervention.

• Perceived self-efficacy in clinical communication skills

  Self-Efficacy Questionnaire (SE-12) Total Score Perceived self-efficacy in clinical communication skills will be assessed using the Self-Efficacy Questionnaire (SE-12), a 12-item self-report instrument measuring confidence in communication and interpersonal interactions. The primary outcome will be the SE-12 total score, reported as a continuous variable (points), with higher scores indicating higher perceived self-efficacy. Only the total score will be used for outcome reporting. The SE-12 has been widely used in educational settings and shows excellent internal consistency (α=0.95), good construct validity, and sensitivity to experience level.

  Baseline (prior to the first laboratory-based practical session), immediately after the intervention (at the conclusion of the final laboratory-based practical session), and follow-up at 8 weeks after the intervention.

Secondary Outcomes (1)

• Students' Satisfaction

  Immediately post-intervention.

Study Arms (2)

Simulation

EXPERIMENTAL

Clinical simulation sessions using standardised patients portraying clients and/or their relatives, who will be attended by students in scenarios related to nursing clinical practice. Each session will include: a briefing (delivered by the facilitator), hands-on simulation (performed by the students), and a structured debriefing using the TALK\[FS(3.1\] tool (facilitated by the academic staff member together with the students). Sessions will be delivered by facilitators trained in simulation. The number of participants per session will be limited to a maximum of 13 students. Simulation activities will take place at Simlab@Learn, within designated simulation facilities. The 10 contact hours will be delivered over the second semester, comprising two 4-hour blocks and one 2-hour block, in accordance with the course timetable. Scenarios may be adapted in terms of complexity according to students' observed performance, while maintaining consistency of the educational objectives.

Other: Clinical Simulation

Role-Play

NO INTERVENTION

Conventional laboratory practice sessions, incorporating informal student-to-student role-play, group discussion, and analysis of clinical cases under academic staff supervision. Sessions will be delivered by academic staff without simulation training. The number of participants per session will be limited to a maximum of 13 students. Sessions will take place at Simlab@Learn, in the relational laboratory. The 10 contact hours will be delivered over the second semester, comprising two 4-hour blocks and one 2-hour block, in accordance with the course timetable.

Interventions

Clinical Simulation OTHER

Clinical simulation sessions using standardised patients portraying clients and/or their relatives, who will be attended by students in scenarios related to nursing clinical practice. Each session will include: a briefing (delivered by the academic staff member), hands-on simulation (performed by the students), and a structured debriefing using the TALK tool (facilitated by the academic staff member together with the students). Sessions will be delivered by academic staff trained in simulation. The number of participants per session will be limited to a maximum of 13 students. Simulation activities will take place at Simlab@Learn, within designated simulation facilities. The 10 contact hours will be delivered over the second semester, comprising two 4-hour blocks and one 2-hour block, in accordance with the course timetable. Scenarios may be adapted in terms of complexity according to students' observed performance, while maintaining consistency of the educational objectives.

Simulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• active enrolment in the first year of the undergraduate Nursing degree programme
• first-time attendance of the Helping Relationship course unit.

You may not qualify if:

• None.

Sponsors & Collaborators

• Escola Superior de Saúde Norte da Cruz Vermelha Portuguesa: lead

Study Sites (1)

Escola Superior de Saúde Norte da Cruz Vermelha Portuguesa

Oliveira de Azeméis, Portugal

Location

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Joana Coelho, PhD

  Escola Superior de Saúde Norte da Cruz Vermelha Portuguesa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2025
• First Posted: February 17, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: February 17, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)