Effect of Simulation on the Enhancement of Clinical Communication Competencies in Nursing Students: Protocol for a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Clinical communication competence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •active enrolment in the first year of the undergraduate Nursing degree programme
- •first-time attendance of the Helping Relationship course unit.
排除标准
- 未提供
研究组 & 干预措施
Simulation
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.
干预措施: Clinical Simulation (Other)
Role-Play
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.
结局指标
主要结局
Clinical communication competence
时间窗: 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.
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.
Perceived self-efficacy in clinical communication skills
时间窗: 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.
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.
次要结局
- Students' Satisfaction(Immediately post-intervention.)