Team-Based Learning Integrated Into Clinical Simulation in Nursing Students
ConditionNursing Education
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pisa
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Team-Based Learning Integrated Clinical Simulation
BehavioralParticipants 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 delivered prior to the clinical simulation and is aligned with curricular objectives of undergraduate nursing education.
Traditional Clinical Simulation
BehavioralParticipants 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: ExperimentalExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Knowledge acquisition related to tracheobronchial suctioning
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.
Time frame
Immediately post-intervention (T0), 3 months (T1), and 6 months (T2)Secondary outcomes
1
Technical skills performance in clinical simulation
Ability to correctly perform tracheobronchial suctioning through a tracheostomy tube in a simulated clinical setting. Technical skills are evaluated using a structured checklist based on the Objective Structured Clinical Examination (OSCE) model. The checklist includes 35 procedural steps, each scored 1 (correctly performed) or 0 (not performed or incorrectly performed). Total scores range from 0 to 35, with higher scores indicating better technical performance.
Time frame
Immediately post-intervention (T0), 3 months (T1), and 6 months (T2)2
Teamwork competencies
Self-reported teamwork competencies, including communication, coordination, problem-solving, and collaboration within a team. Competencies are measured using the validated Teamwork Competency Scale (TCS), consisting of 31 items rated on a 5-point Likert scale (1 = never, 5 = always). Total scores range from 31 to 155, with higher scores indicating better perceived teamwork competencies
Time frame
Immediately post-intervention (T0), 3 months (T1), and 6 months (T2)Other outcomes
1
Attitude toward Team-Based Learning
Students' attitudes toward the Team-Based Learning methodology, including satisfaction, perceived usefulness, engagement, and contribution to learning. Attitudes are assessed using the Attitude Toward Team-Based Learning (ATL) questionnaire, consisting of 6 items rated on a 5-point Likert scale (1 = not at all; 5 = very much). Total scores range from 6 to 30, with higher scores indicating a more positive attitude toward Team-Based Learning.
Time frame
Immediately post-intervention (T0), 3 months (T1), and 6 months (T2)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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