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NCT Number: NCT07444229

Team-Based Learning Integrated Into Clinical Simulation in Nursing Students

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.

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Key information

Conditions

Nursing Education

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Knowledge acquisition related to tracheobronchial suctioning

    Time frame: 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.

Secondary outcomes

  1. Technical skills performance in clinical simulation

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

    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.

  2. Teamwork competencies

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

    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

Other outcomes

  1. Attitude toward Team-Based Learning

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nicola Pagnucci, RN, MSN, PhD

CONTACT

[email protected]

+393472483475

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Registry information

Official study title

Effectiveness of Team-Based Learning Integrated Into Clinical Simulation in Nursing Education: A Randomized Controlled Trial (TBLab)

Acronym: TBLab

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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