Effectiveness of Team-Based Learning Integrated Into Clinical Simulation in Nursing Education: A Randomized Controlled Trial (TBLab)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Knowledge acquisition related to tracheobronchial suctioning
研究概览
简要总结
This study aims to evaluate whether integrating Team-Based Learning (TBL) into clinical simulation improves learning outcomes in undergraduate nursing students compared with traditional simulation alone.
Team-Based Learning (TBL) is an educational approach that actively involves students in small groups through individual preparation, teamwork, and application of knowledge to real-world problems. Clinical simulation is already widely used in nursing education to help students practice technical and non-technical skills in a safe environment. Combining these two approaches may enhance learning, but evidence is still limited.
In this randomized controlled trial, third-year nursing students enrolled in the Bachelor of Nursing program at the University of Pisa will be randomly assigned to one of two groups. One group will receive a Team-Based Learning session before participating in a clinical simulation, while the control group will take part in standard simulation activities without TBL.
The study will assess students' knowledge, technical skills, and teamwork competencies immediately after the educational activities and again at three and six months to evaluate retention of learning outcomes. Participation is voluntary and does not involve additional risks beyond standard educational activities.
详细描述
This study is a single-center randomized controlled trial designed to evaluate the effectiveness of integrating Team-Based Learning (TBL) into clinical simulation activities in undergraduate nursing education. The trial will be conducted within the Bachelor of Nursing program at the University of Pisa and will involve third-year nursing students participating in curricular simulation-based training.
Participants who provide informed consent will be randomly assigned in a 1:1 ratio to either an experimental group or a control group. The experimental group will receive a structured Team-Based Learning intervention prior to the clinical simulation session. This intervention includes individual preparation using evidence-based learning materials, an Individual Readiness Assurance Test (I-RAT), a Team Readiness Assurance Test (T-RAT), team-based application activities, and structured feedback and debriefing.
The control group will participate in standard clinical simulation activities according to the existing undergraduate nursing curriculum, without integration of the Team-Based Learning methodology. All simulation activities focus on tracheobronchial suctioning through a tracheostomy tube, a complex nursing procedure requiring integration of theoretical knowledge, technical skills, and teamwork competencies.
Outcome measures include knowledge acquisition, technical skill performance assessed through a structured checklist, and teamwork competencies measured using validated instruments. Assessments will be conducted immediately after the intervention (T0) and at follow-up time points of three months (T1) and six months (T2) to evaluate both immediate learning effects and retention over time.
The study is embedded within routine educational activities and is classified as minimal risk. No clinical interventions are involved, and participation or non-participation does not affect students' academic evaluation or progression. Results will contribute to the evidence base on innovative educational strategies in nursing education and support the development of effective, evidence-informed teaching practices.
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
- None
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
- •Enrollment in the third year of the Bachelor of Nursing program at the University of Pisa.
- •Participation in scheduled clinical simulation activities as part of the undergraduate nursing curriculum.
- •Provision of written informed consent to participate in the study
排除标准
- 未提供
研究组 & 干预措施
Experimental
Team-Based Learning Integrated Simulation
干预措施: Team-Based Learning Integrated Clinical Simulation (Behavioral)
Control
Traditional Clinical Simulation
干预措施: Traditional Clinical Simulation (Behavioral)
结局指标
主要结局
Knowledge acquisition related to tracheobronchial suctioning
时间窗: Immediately post-intervention (T0), 3 months (T1), and 6 months (T2)
Level of theoretical knowledge related to tracheobronchial suctioning through a tracheostomy tube, including indications, procedural steps, safety aspects, and evidence-based recommendations. Knowledge is assessed using the Individual Readiness Assurance Test (I-RAT) consisting of 10 multiple-choice questions. Each correct answer is awarded 1 point, while incorrect answers receive 0 points. Total scores range from 0 to 10, with higher scores indicating greater knowledge.
次要结局
- Technical skills performance in clinical simulation(Immediately post-intervention (T0), 3 months (T1), and 6 months (T2))
- Teamwork competencies(Immediately post-intervention (T0), 3 months (T1), and 6 months (T2))
研究者
Nicola Pagnucci
Senior Researcher
University of Pisa