Simulation on the Enhancement of Clinical Communication Competencies in Nursing Students

Methods/Design This protocol was developed in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines.

Patient and Public Involvement, Trial Design No target-population involvement was undertaken during the planning of this study, as input from first-year undergraduate students-who have neither clinical practice nor prior exposure to the pedagogical strategies under evaluation-could have been driven by assumptions or perceptions with limited grounding. Conversely, the literature indicates that when the target population is inexperienced with the educational strategy being assessed, it is more appropriate to involve stakeholders with greater expertise at the design stage, such as academic staff, given their knowledge and experience, this approach was adopted in the present study.

Participants, Interventions, and Outcomes Trial setting The study will be conducted at a private higher education institution for health sciences in Portugal. It is a parallel-group randomised controlled trial with a superiority framework, aiming to evaluate whether simulation as an educational strategy leads to greater improvements in clinical communication skills than conventional teaching. In this trial, the superiority assumption is grounded in the objective of demonstrating that the intervention is superior-that is, that it yields a statistically significantly better outcome on the primary endpoint.

The unit of randomisation will be the individual student; that is, each student will be randomly allocated to one of the study groups. Allocation will be performed at a 1:1 ratio, with half of the students assigned to the intervention group (simulation) and the other half to the control group (conventional teaching-role-play).

Eligibility criteria Participants will be required to meet the following inclusion criteria: (a) active enrolment in the first year of the undergraduate Nursing degree programme, and (b) first-time attendance of the Helping Relationship course unit. Under these assumptions, no additional exclusion criteria will be applied.

Facilitators delivering the intervention will be academic staff from ESSNorteCVP who meet the following criteria: (a) certified training in clinical simulation, (b) a minimum of two years' experience in nursing education, and (c) attendance at the course preparation meeting to ensure familiarity with the study procedures.

Intervention and comparator Participants in the intervention and control groups will receive different pedagogical approaches, both delivered within the 10 contact hours of laboratory practice sessions in the Helping Relationship course unit. The main characteristics of the intervention and the comparator are presented below.

Intervention (Clinical Simulation) The intervention consists of clinical simulation sessions using standardised patients who portray clients and/or their relatives in scenarios grounded in nursing clinical practice. Each simulation session follows a structured pedagogical sequence comprising three core components: (i) a briefing, delivered by an academic staff member to contextualise the scenario and clarify learning objectives; (ii) hands-on simulation, during which students actively engage with the standardised patient; and (iii) a structured debriefing, facilitated by academic staff together with the students and guided by the TALK debriefing tool.

All sessions are delivered by academic staff trained in simulation-based education. The number of participants is limited to a maximum of 13 students per session, ensuring optimal interaction and feedback. Simulation activities take place at Simlab@Learn, within designated simulation facilities specifically equipped for this type of educational strategy.

The total intervention comprises 10 contact hours, delivered during the second semester in accordance with the course timetable. These hours are organised into two 4-hour blocks and one 2-hour block.

Simulation scenarios may be adapted in terms of complexity according to students' observed performance, while preserving consistency with the predefined educational objectives.

Educational materials used in the intervention include clinical scenarios enacted by standardised patients, observation and performance checklists, and structured debriefing support sheets. These materials are mandatory for the implementation of the intervention and are made available to facilitators via the institutional platform (INFORDocente). Participants in the intervention group do not have access to the educational strategies used in the control group.

Comparator (Conventional Teaching) The comparator consists of conventional laboratory practice sessions, incorporating informal student-to-student role-play, group discussion, and analysis of clinical cases, all conducted under the supervision of academic staff. These sessions do not involve the use of standardised patients or structured simulation methodologies.

Sessions are delivered by academic staff without specific training in simulation-based education. As in the intervention group, participation is limited to a maximum of 13 students per session. Teaching activities take place at Simlab@Learn, specifically within the relational laboratory.

The comparator also comprises 10 contact hours, delivered during the second semester and organised into two 4-hour blocks and one 2-hour block, in alignment with the course timetable.

Educational materials consist of vignettes that provide brief descriptions of clinical situations or cases to support discussion and analysis. Participants in the comparator group do not have access to the simulation-based strategies used in the intervention group.

Although this study does not involve invasive interventions or direct clinical risk, criteria have been defined for discontinuing a student's participation in either the intervention or the control group in order to safeguard participants' wellbeing and the validity of the data. A student may interrupt or discontinue participation in the following circumstances: (a) upon request, by withdrawing informed consent; (b) exacerbated emotional distress (e.g., heightened anxiety), whether self-reported or perceived by the academic staff member; (c) withdrawal from the course unit; or (d) completion of the course unit via the examination-based assessment option.

To maximise student adherence to the study, the following measures will be implemented: (a) clear engagement of students within the informed consent process; (b) provision, in the first session of the course unit by the course lead, of information regarding the aims, duration, and benefits of participation; and (c) delivery of reminders via INFOREstudante prior to each laboratory practice session.

Participant adherence will be monitored through attendance registers for all sessions, duly signed by the students and the academic staff member.

To ensure fidelity to the pedagogical approach, the following measures will be undertaken: (a) the study and its pedagogical alignment will be presented at the course preparation meeting; (b) all required materials will be made available to academic staff at that meeting; (c) at least 50% of the total laboratory practice (PL) teaching hours (i.e., a minimum of 5 hours) will be observed by a member of the research team to verify (1) the conduct of the briefing and debriefing, (2) the use of the scenarios, (3) the absence of simulation elements within conventional teaching, and (4) adherence to the planned duration of each session; and (d) regular meetings will be held with academic staff between laboratory practice sessions to review implementation processes and procedures.

For data analysis purposes, participants will be classified as follows: (a) protocol-adherent-attendance at ≥80% of the allocated laboratory practice sessions and completion of the planned educational activities; (b) protocol-non-adherent-attendance below 80% and/or non-completion of the planned educational activities; and (c) students who discontinue participation before completing the first laboratory practice session or who withdraw voluntarily-who will be excluded from the final analysis. The ≥80% threshold is justified on two grounds: (a) pedagogical logistics, as the laboratory practice sessions comprise two 4-hour blocks and one 2-hour block; thus, attendance at the two 4-hour sessions is expected to represent adequate exposure to the intervention to support a per-protocol analysis; and (b) the literature in this field indicates that adherence levels above 75% are recommended for studies evaluating educational approaches.

During the study period, students may continue to attend all other course units scheduled within the first-year undergraduate nursing curriculum, provided these do not include specific interventions focused on clinical communication in a simulated context. Students will be informed of this restriction at the time of consent and will be asked to notify the research team if they are enrolled in any such activities. Nonetheless, participants will be invited to complete a brief questionnaire at the end of the intervention regarding: (a) whether they took part in any other activities related to clinical communication or simulation; (b) the type, duration, and setting of those activities; and (c) whether they believe these activities influenced their performance in the laboratory practice sessions. This information may be relevant to a more nuanced interpretation of the study findings.

Outcomes The primary outcomes focus on students' level of clinical communication competence, assessed using the Interpersonal Communication Assessment Scale (ICAS), which has been adapted and validated for the Portuguese population, specifically among nursing students \[46\]. As well as perceived self-efficacy in clinical communication skills, assessed using the Self-Efficacy Questionnaire (SE-12). This instrument has been used in both national and international studies conducted in educational settings, which supports the decision to employ it in the present trial.

Secondary outcomes relate to satisfaction with the learning experience. Clinical communication competence is assessed using the Interpersonal Communication Assessment Scale (ICAS). This outcome is measured at two time points: pre-intervention and post-intervention. The primary analytic approach consists of calculating change scores between baseline and post-intervention assessments. Results will be reported as means and standard deviations, stratified by study group.

Perceived self-efficacy in clinical communication skills is evaluated using the Self-Efficacy Questionnaire (SE-12). As with clinical communication competence, this outcome is assessed at pre-intervention and post-intervention. Analysis will focus on change scores derived from differences between the two assessment points. Outcomes will be summarised using means and standard deviations by group.

Student satisfaction with the educational strategy is measured using a questionnaire administered post-intervention only. For this outcome, the final score will be analysed. Results will be presented as means and standard deviations by group.

Harms In this study, an "adverse event" is defined as any negative occurrence related to participation in either the intervention or the control condition, such as: (a) significant anxiety during or after sessions; (b) frustration, humiliation, and/or inability to engage with the simulated scenario; and (c) any perceived negative consequence leading to changes in emotional wellbeing or withdrawal from participation. During sessions, the lecturer/facilitator will use an observation checklist to monitor signs of emotional distress, including avoidance behaviour, crying, restlessness, sweating, facial flushing, and-where indicated-participants may be referred to the institution's Mental Health and Wellbeing Service. Records of a

• Students' Satisfaction [Срок оценки: Immediately post-intervention.]