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.

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• None

Individual participant data will not be shared because the study involves undergraduate students and collects educational data that are anonymized and intended to be analyzed and reported only in aggregated form, in accordance with data protection regulations.