in Situ SimulationNCT07346937
Evaluating the Impact of In-Situ Simulation on Interprofessional Healthcare Team Training
A study testing In Situ Simulation and Simulation Center in people with in Situ Simulation and Simulation in Training Center, run by Universidade do Porto at 2 sites in Portugal.
Trial summary
Clinical simulation has established itself as an essential methodology in healthcare training, enabling the development of technical and non-technical skills in controlled and safe environments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- in Situ Simulation, Simulation in Training Center
- What is being tested?
- In Situ Simulation and Simulation Center
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesPortugal
- Study dates
- Feb 2026to 31 Jul 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Professionals working in the surgical center of ULSM-HPH with at least 6 months of experience in the role.
- Availability to participate in the simulation group assigned to them.
Who cannot join
- Professionals who do not work in the surgical center.
- Participants who cannot complete all phases of the study due to scheduling or health restrictions.
- Pregnant professionals.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Maria do Céu F Campos contact
Portugal2 sites
ULS Matosinhos - Hospital Pedro Hispano
Matosinhos Municipality, 4464-513
Maria do Céu F Campos, +351 964 131 846, mariaceucampos@gmail.com
Rita Resende, MD, ritaresende@yahoo.com
Faculty of Medicine, University of Porto
Porto, 4200-319
Maria do Céu F Campos, +351 964 131 846, mariaceucampos@gmail.com
Abel Nicolau, PhD, anicolau@med.up.pt
About this study
Official title: Evaluating the Impact of In-Situ Simulation on Interprofessional Healthcare Team Training: A Randomized Trial
Clinical simulation has established itself as an essential methodology in healthcare training, enabling the development of technical and non-technical skills in controlled and safe environments. This study proposes a randomized trial that compares the impact of two learning contexts-a simulation center and the in situ simulation (ISS) environment in the operating room-on the training of interprofessional teams. The aim is to evaluate the effectiveness and efficiency of each context in the acquisition and performance of technical and non-technical skills, as well as participants' perceptions of realism, teamwork, and patient safety. The randomized experimental design reinforces the methodological rigor and internal validity of the results, allowing the identification of important differences between the two approaches. The scarcity of studies on interprofessional simulation in a real clinical context underscores the relevance of this research, which may provide scientific evidence to guide training policies and promote safer, more collaborative practices. It is expected that the results will contribute to improving interprofessional training programs and supporting the systematic integration of ISS in the healthcare field, especially in high-complexity environments.
Read the detailed description
The increasing complexity of healthcare and the need for a coordinated response among different professionals make interprofessional teamwork an essential element for patient safety and quality of care. In this context, clinical simulation has established itself as a fundamental teaching and learning methodology, allowing the training of technical and non-technical skills in controlled and safe environments. Among the different simulation modalities, in situ simulation (ISS) has gained prominence because it occurs in the clinical context itself, involving real teams and resources of the hospital environment. This approach favors the identification of latent threats to safety and the analysis of workflows and communication in high-pressure scenarios. In addition, ISS has demonstrated a positive impact on safety culture and the performance of multidisciplinary teams. Several studies support that simulation based on interprofessional teams promotes mutual understanding of roles, respect between disciplines, and effective coordination during critical situations. The integration of professionals from different areas in realistic scenarios enhances collaborative learning and strengthens communication, leadership, and decision-making skills, central aspects of Non-Technical Skills (NTS). Despite the available evidence, there is still a gap in the literature regarding the direct comparison between simulation in a training center and ISS in the hospital setting, particularly in the surgical center, an environment characterized by professional interdependence and high technical complexity. Thus, this study proposes a randomized trial comparing the impact of ISS and simulation in a training center on the formation of interprofessional teams. The aim is to systematically evaluate the effect of each context on the acquisition and performance of technical and non-technical skills, as well as on professionals' perception of realism, training effectiveness, and patient safety. This study, therefore, aims to contribute to the development of more effective training strategies based on scientific evidence.
- Conditions
- in Situ Simulation, Simulation in Training Center
- Being tested
- In Situ Simulation, Simulation Center
- Keywords
- In Situ Simulation, Simulation Center, Interprofessional Team Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In Situ SimulationOther
Simulation scenario carried out in situ. The training team will consist of 3 facilitators (who will always be the same throughout the study), with each scenario having only 2 facilitators and the principal investigator.
Each group will be subjected to the same simulation scenario, the process of which is approximately 60 minutes, divided into: Briefing - 10 min; Scenario Development - 15 minutes; Debriefing - 30/35 min.
Simulation CenterOther
Simulation scenario carried out in the Simulation Center. The training team will consist of 3 facilitators (who will always be the same throughout the study), with each scenario having only 2 facilitators and the principal investigator.
Each group will be subjected to the same simulation scenario, the process of which is approximately 60 minutes, divided into: Briefing - 10 min; Scenario Development - 15 minutes; Debriefing - 30/35 min.
| Study group | Role | What they receive |
|---|---|---|
| In Situ Simulation | Experimental | Half of the teams will carry out the scenario in an in-situ context, at the ULS Matosinhos - Pedro Hispano Hospital (ULSM-HPH). Receives: Other: In Situ Simulation |
| Simulation Center | Active comparator | Half of the teams will carry out the scenario in a Simulation Center context, at the Faculty of Medicine, University of Porto (SIMFMUP). Receives: Other: Simulation Center |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simulation Effectiveness (SET-M)
Measured with Simulation Effectiveness Tool - Modified (SET-M). SET-M is a 19-item tool with a three-point Likert scale that measures effectiveness by capturing student feedback on three domains.
The higher the score, the more effective the simulation training.
Measured: Immediately after the simulation session (Day 1)
Simulation Effectiveness (ICCAS)
Measured with the Interprofessional Collaborative Competencies Attainment Survey (ICCAS).
ICCAS is a 20-item self-report tool with a seven-point Likert scale that evaluates the participants' competencies in six dimensions before and after the simulation. Participants complete the tool after simulation training, but rate their abilities twice: once as they recall them before training, and after that training is done.
The higher the score, the more effective the simulation training.
Measured: Immediately after the simulation session (Day 1)
Simulation Design Evaluation
Evaluated using Simulation Design Scale (SDS) - Student version. SDS is a 20-item tool with a five-point Likert scale designed to evaluate five design features of instructor-developed simulations.
The instrument has two parts: the presence of specific features in the simulation and the importance of those features to the learner.
The higher the score, the higher the evaluation of the design feature.
Measured: Immediately after the simulation session (Day 1)
Simulation Debriefing Assessment
Measured with the Debriefing Assessment for Simulation in Healthcare (DASH) Short version for students and for instructors.
DASH for students has students evaluating the instructors in 6 elements with a seven-point Likert scale, while DASH for instructors is a self-assessment tool with the same structure.
The higher the score, the higher the debriefing skill.
Measured: Immediately after the simulation session (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for in Situ SimulationStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Pedro Hispano, ULS Matosinhos
- Responsible party
- Sponsor
- Investigators
- Maria do Céu F Campos, Principal investigator, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346937
- Sponsor's protocol ID
- In-Situ Simulation
- Status last verified
- Dec 2025
- First submitted
- 10 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of In-Situ Simulation on Interprofessional Healthcare Team Training: A Randomized Trial
- ClinicalTrials.gov ID
- NCT07346937
- Acronym / sponsor ID
- In-Situ Simulation
- Conditions
- in Situ Simulation, Simulation in Training Center
- Keywords
- In Situ Simulation, Simulation Center, Interprofessional Team Training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Hospital Pedro Hispano, ULS Matosinhos
- Study start
- Feb 2026 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 16 Jan 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.
Clinical simulation has established itself as an essential methodology in healthcare training, enabling the development of technical and non-technical skills in controlled and safe environments. This study proposes a randomized trial that compares the impact of two learning contexts-a simulation center and the in situ simulation (ISS) environment in the operating room-on the training of interprofessional teams. The aim is to evaluate the effectiveness and efficiency of each context in the acquisition and performance of technical and non-technical skills, as well as participants' perceptions of realism, teamwork, and patient safety. The randomized experimental design reinforces the methodological rigor and internal validity of the results, allowing the identification of important differences between the two approaches. The scarcity of studies on interprofessional simulation in a real clinical context underscores the relevance of this research, which may provide scientific evidence to guide training policies and promote safer, more collaborative practices. It is expected that the results will contribute to improving interprofessional training programs and supporting the systematic integration of ISS in the healthcare field, especially in high-complexity environments.
Detailed description
The increasing complexity of healthcare and the need for a coordinated response among different professionals make interprofessional teamwork an essential element for patient safety and quality of care. In this context, clinical simulation has established itself as a fundamental teaching and learning methodology, allowing the training of technical and non-technical skills in controlled and safe environments. Among the different simulation modalities, in situ simulation (ISS) has gained prominence because it occurs in the clinical context itself, involving real teams and resources of the hospital environment. This approach favors the identification of latent threats to safety and the analysis of workflows and communication in high-pressure scenarios. In addition, ISS has demonstrated a positive impact on safety culture and the performance of multidisciplinary teams. Several studies support that simulation based on interprofessional teams promotes mutual understanding of roles, respect between disciplines, and effective coordination during critical situations. The integration of professionals from different areas in realistic scenarios enhances collaborative learning and strengthens communication, leadership, and decision-making skills, central aspects of Non-Technical Skills (NTS). Despite the available evidence, there is still a gap in the literature regarding the direct comparison between simulation in a training center and ISS in the hospital setting, particularly in the surgical center, an environment characterized by professional interdependence and high technical complexity. Thus, this study proposes a randomized trial comparing the impact of ISS and simulation in a training center on the formation of interprofessional teams. The aim is to systematically evaluate the effect of each context on the acquisition and performance of technical and non-technical skills, as well as on professionals' perception of realism, training effectiveness, and patient safety. This study, therefore, aims to contribute to the development of more effective training strategies based on scientific evidence.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In Situ Simulation | Experimental | Other: In Situ SimulationHalf of the teams will carry out the scenario in an in-situ context, at the ULS Matosinhos - Pedro Hispano Hospital (ULSM-HPH). |
| Simulation Center | Active comparator | Other: Simulation CenterHalf of the teams will carry out the scenario in a Simulation Center context, at the Faculty of Medicine, University of Porto (SIMFMUP). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Professionals working in the surgical center of ULSM-HPH with at least 6 months of experience in the role.
- Availability to participate in the simulation group assigned to them.
Key exclusion criteria (3 listed)
- Professionals who do not work in the surgical center.
- Participants who cannot complete all phases of the study due to scheduling or health restrictions.
- Pregnant professionals.
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 |
|---|---|---|
| In Situ SimulationSimulation scenario carried out in situ. The training team will consist of 3 facilitators (who will always be the same throughout the study), with each scenario having only 2 facilitators and the principal investigator. Each group will be subjected to the same simulation scenario, the process of which is approximately 60 minutes, divided into: Briefing - 10 min; Scenario Development - 15 minutes; Debriefing - 30/35 min. | Other | In Situ Simulation |
| Simulation CenterSimulation scenario carried out in the Simulation Center. The training team will consist of 3 facilitators (who will always be the same throughout the study), with each scenario having only 2 facilitators and the principal investigator. Each group will be subjected to the same simulation scenario, the process of which is approximately 60 minutes, divided into: Briefing - 10 min; Scenario Development - 15 minutes; Debriefing - 30/35 min. | Other | Simulation Center |
Primary outcome
Simulation Effectiveness (SET-M)
Time frame: Immediately after the simulation session (Day 1)
Measured with Simulation Effectiveness Tool - Modified (SET-M). SET-M is a 19-item tool with a three-point Likert scale that measures effectiveness by capturing student feedback on three domains. The higher the score, the more effective the simulation training.
Simulation Effectiveness (ICCAS)
Time frame: Immediately after the simulation session (Day 1)
Measured with the Interprofessional Collaborative Competencies Attainment Survey (ICCAS). ICCAS is a 20-item self-report tool with a seven-point Likert scale that evaluates the participants' competencies in six dimensions before and after the simulation. Participants complete the tool after simulation training, but rate their abilities twice: once as they recall them before training, and after that training is done. The higher the score, the more effective the simulation training.
Simulation Design Evaluation
Time frame: Immediately after the simulation session (Day 1)
Evaluated using Simulation Design Scale (SDS) - Student version. SDS is a 20-item tool with a five-point Likert scale designed to evaluate five design features of instructor-developed simulations. The instrument has two parts: the presence of specific features in the simulation and the importance of those features to the learner. The higher the score, the higher the evaluation of the design feature.
Simulation Debriefing Assessment
Time frame: Immediately after the simulation session (Day 1)
Measured with the Debriefing Assessment for Simulation in Healthcare (DASH) Short version for students and for instructors. DASH for students has students evaluating the instructors in 6 elements with a seven-point Likert scale, while DASH for instructors is a self-assessment tool with the same structure. The higher the score, the higher the debriefing skill.
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 16 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
Maria do Céu F Campos contact
Maria do Céu F Campos principal investigator
Universidade do Porto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In Situ Simulation and Simulation Center in people with in Situ Simulation and Simulation in Training Center, run by Universidade do Porto at 2 sites in Portugal.
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 2 inclusion and 3 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 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Janete Santos, PhD (+351 220 426 569, investigaclinica@med.up.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Simulation Effectiveness (SET-M) (time frame: Immediately after the simulation session (Day 1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2026.