NCT07346937

Brief 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. 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Feb 2026Jul 2026

First Submitted

Initial submission to the registry

December 10, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Expected
Last Updated

January 16, 2026

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

December 10, 2025

Last Update Submit

January 7, 2026

Conditions

Keywords

In Situ SimulationSimulation CenterInterprofessional Team Training

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    Immediately after the simulation session (Day 1)

Study Arms (2)

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).

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).

Other: Simulation Center

Interventions

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.

In Situ Simulation

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.

Simulation Center

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ULS Matosinhos - Hospital Pedro Hispano

Matosinhos Municipality, 4464-513, Portugal

Location

Faculty of Medicine, University of Porto

Porto, 4200-319, Portugal

Location

Study Officials

  • Maria do Céu F Campos

    Universidade do Porto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria do Céu F Campos

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2025

First Posted

January 16, 2026

Study Start

February 1, 2026

Primary Completion

May 1, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

January 16, 2026

Record last verified: 2025-12

Locations