Team-Based Learning Integrated Into Clinical Simulation in Nursing Students

NCT07444229 | Not Yet Recruiting

• 1 other identifier: TBLab-UNIPI-2026
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Nursing Education

Keywords

Nursing education; Team-Based Learning; Clinical simulation; Undergraduate nursing students; Educational intervention; Randomized controlled trial; Simulation-based education; Active learning; Teamwork skills

Outcome Measures

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.

  Immediately post-intervention (T0), 3 months (T1), and 6 months (T2)

Secondary Outcomes (2)

• 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)

Other Outcomes (1)

• Attitude toward Team-Based Learning

  Immediately post-intervention (T0), 3 months (T1), and 6 months (T2)

Study Arms (2)

Experimental

EXPERIMENTAL

Team-Based Learning Integrated Simulation

Behavioral: Team-Based Learning Integrated Clinical Simulation

Control

ACTIVE COMPARATOR

Traditional Clinical Simulation

Behavioral: Traditional Clinical Simulation

Interventions

Team-Based Learning Integrated Clinical Simulation BEHAVIORAL

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 delivered prior to the clinical simulation and is aligned with curricular objectives of undergraduate nursing education.

Experimental

Traditional Clinical Simulation BEHAVIORAL

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Pisa: lead

Related Publications (3)

• 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 RESULT

• 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 RESULT

• 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 RESULT

Study Officials

• Nicola Pagnucci, RN, MSN, PhD

  University of Pisa

  STUDY DIRECTOR

Central Study Contacts

Nicola Pagnucci, RN, MSN, PhD

CONTACT

+393472483475; nicola.pagnucci@unipi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Model Details: This is a parallel-group randomized controlled trial in which participants are allocated in a 1:1 ratio to either an experimental group or a control group. The experimental group receives a structured educational intervention integrating Team-Based Learning into a clinical simulation session, while the control group participates in standard clinical simulation without Team-Based Learning. Both groups follow the same curricular simulation activities and are assessed using the same outcome measures at predefined time points. No crossover between groups is planned.

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 2, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share