Nursing EducationTBLabNCT07444229
Team-Based Learning Integrated Into Clinical Simulation in Nursing Students
A study testing Team-Based Learning Integrated Clinical Simulation and Traditional Clinical Simulation in people with Nursing Education, run by University of Pisa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nursing Education
- What is being tested?
- Team-Based Learning Integrated Clinical Simulation and Traditional Clinical Simulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Team-Based Learning Integrated Into Clinical Simulation in Nursing Education: A Randomized Controlled Trial (TBLab)
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.
Read more
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.
Read the 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.
- Conditions
- Nursing Education
- Being tested
- Team-Based Learning Integrated Clinical Simulation, Traditional Clinical Simulation
- Keywords
- Nursing education, Team-Based Learning, Clinical simulation, Undergraduate nursing students, Educational intervention, Randomized controlled trial, Simulation-based education, Active learning, Teamwork skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Team-Based Learning Integrated Clinical SimulationBehavioural
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 SimulationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Team-Based Learning Integrated Simulation Receives: Behavioral: Team-Based Learning Integrated Clinical Simulation |
| Control | Active comparator | Traditional Clinical Simulation Receives: Behavioral: Traditional Clinical Simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately post-intervention (T0), 3 months (T1), and 6 months (T2)
Secondary outcomes (2)
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.
Measured: Immediately post-intervention (T0), 3 months (T1), and 6 months (T2)
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
Measured: Immediately post-intervention (T0), 3 months (T1), and 6 months (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nursing EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Pagnucci, University of Pisa
- Investigators
- Nicola Pagnucci, RN, MSN, PhD, Study director, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444229
- Sponsor's protocol ID
- TBLab-UNIPI-2026
- Acronym
- TBLab
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 34012208Alberti 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.
PubMed 33385942Parmelee 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.
PubMed 22471941
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Team-Based Learning Integrated Into Clinical Simulation in Nursing Education: A Randomized Controlled Trial (TBLab)
- ClinicalTrials.gov ID
- NCT07444229
- Acronym / sponsor ID
- TBLab / TBLab-UNIPI-2026
- Conditions
- Nursing Education
- Keywords
- Nursing education, Team-Based Learning, Clinical simulation, Undergraduate nursing students, Educational intervention, Randomized controlled trial, Simulation-based education, Active learning
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Team-Based Learning Integrated Clinical SimulationTeam-Based Learning Integrated Simulation |
| Control | Active comparator | Behavioral: Traditional Clinical SimulationTraditional Clinical Simulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Team-Based Learning Integrated Clinical SimulationParticipants 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. | Behavioural | Experimental |
| Traditional Clinical SimulationParticipants 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. | Behavioural | Control |
Primary outcome
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.
2 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Results publication: PubMed 34012208Koukourikos 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.
- Results publication: PubMed 33385942Alberti 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.
- Results publication: PubMed 22471941Parmelee 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicola Pagnucci, RN, MSN, PhD study director
University of Pisa
Questions about this trial
What is this clinical trial studying?
A study testing Team-Based Learning Integrated Clinical Simulation and Traditional Clinical Simulation in people with Nursing Education, run by University of Pisa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicola Pagnucci, RN, MSN, PhD (+393472483475, nicola.pagnucci@unipi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge acquisition related to tracheobronchial suctioning (time frame: Immediately post-intervention (T0), 3 months (T1), and 6 months (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07444229, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.