Team-Based Learning Integrated Into Clinical Simulation in Nursing Students
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Team-Based Learning Integrated Clinical Simulation, Traditional Clinical Simulation.
- Who it may be relevant to
- Registry conditions: Nursing Education. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of Team-Based Learning Integrated Into Clinical Simulation in Nursing Education: A Randomized Controlled Trial (TBLab)
Overview
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.
Detailed description
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.
Interventions
- Behavioral Team-Based Learning Integrated Clinical Simulation
Participants receive a structured educational intervention integrating Team-Based Learning into a clinical simulation session. The intervention includes individual pre-class preparation using evidence-based learning materials, an Individual Readiness Assurance Test (I-RAT), a Team Readiness Assurance Test (T-RAT), team-based application activities focused on clinical decision-making, and structured feedback and debriefing facilitated by trained tutors. The Team-Based Learning session is deliver - Behavioral Traditional Clinical Simulation
Participants receive standard clinical simulation activities as part of the undergraduate nursing curriculum. The simulation follows established educational practices routinely used in nursing education and does not include Team-Based Learning components such as readiness assurance tests, structured team application activities, or formal peer evaluation. Simulation content, learning objectives, duration, and assessment time points are aligned with those of the experimental group.
Primary outcome measures
- Knowledge acquisition related to tracheobronchial suctioning [Time frame: Immediately post-intervention (T0), 3 months (T1), and 6 months (T2)]
Secondary outcome measures (2)
- Technical skills performance in clinical simulation [Time frame: Immediately post-intervention (T0), 3 months (T1), and 6 months (T2)]
- Teamwork competencies [Time frame: Immediately post-intervention (T0), 3 months (T1), and 6 months (T2)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Koukourikos K, Tsaloglidou A, Kourkouta L, Papathanasiou IV, Iliadis C, Fratzana A, Panagiotou A. Simulation in Clinical Nursing Education. Acta Inform Med. 2021 Mar;29(1):15-20. doi: 10.5455/aim.2021.29.15-20. PMID 34012208
- Alberti S, Motta P, Ferri P, Bonetti L. The effectiveness of team-based learning in nursing education: A systematic review. Nurse Educ Today. 2021 Feb;97:104721. doi: 10.1016/j.nedt.2020.104721. Epub 2020 Dec 11. PMID 33385942
- Parmelee D, Michaelsen LK, Cook S, Hudes PD. Team-based learning: a practical guide: AMEE guide no. 65. Med Teach. 2012;34(5):e275-87. doi: 10.3109/0142159X.2012.651179. Epub 2012 Apr 4. PMID 22471941
Identifiers
NCT: NCT07444229 · TBLab-UNIPI-2026