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| ID | Type | Description | Link |
|---|---|---|---|
| 2025/CE/P13 | Other Identifier | Comissao de Etica ICBAS |
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| Name | Class |
|---|---|
| Polytechnic Institute of Porto | OTHER |
| Universidade do Porto | OTHER |
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This randomized controlled trial evaluates and compares the educational effectiveness of two arthroscopic training platforms: a traditional physical bench-model simulator and an immersive Mixed Reality (MR) simulator. Medical students and residents undergo a baseline assessment on a physical knee simulator and are then randomized into either the Traditional Simulator Group (TSG) or the Mixed Reality Simulator Group (MRSG). Participants complete a three-session training protocol focusing on basic psychomotor skills. Trainees are then evaluated on an anatomical knee task to measure true clinical skill transfer. Performance is video-recorded and scored by independent, blinded physicians using the validated Arthroscopic Surgical Skill Evaluation Tool (ASSET).
This parallel-group randomized controlled trial aims to evaluate the educational efficacy of Mixed Reality in surgical education. Medical students and residents undergo a baseline assessment on a physical anatomical knee simulator to establish initial skill levels. Following this, participants are randomized into either the Traditional Simulator Group (TSG) or the Mixed Reality Simulator Group (MRSG).
The intervention consists of a three-session training protocol focusing on basic psychomotor skills (specifically horizontal and spatial triangulation) isolated from anatomical clutter. To evaluate true clinical skill transfer, trainees are then tested on an identical anatomical knee task. All performance sessions are video-recorded and subsequently scored by independent, blinded physicians using the validated Arthroscopic Surgical Skill Evaluation Tool (ASSET) to ensure objective outcome measurement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Simulator Group (TSG) | Active Comparator | Participants train using a traditional physical bench-model simulator. The system features an enclosed chamber occluded from direct line-of-sight, forcing trainees to rely exclusively on an external video monitor for visual guidance. The training consists of three individual sessions (maximum 10 minutes each) performing horizontal coordination and spatial triangulation tasks using physical tools. |
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| Mixed Reality Simulator Group (MRSG) | Experimental | Participants train using an immersive Mixed Reality (MR) simulator. The system uses MR glasses to view holographic images inside the enclosure and provides instructional visual guidance via a virtual monitor, replacing the traditional external video monitor. The training consists of three individual sessions (maximum 10 minutes each) performing horizontal coordination and spatial triangulation tasks using physical tools. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional Simulator Training | Other | Execution of a three-session psychomotor training protocol utilizing a physical bench-model simulator with an external video monitor for visual guidance. |
| Measure | Description | Time Frame |
|---|---|---|
| Psychomotor Skill Performance Assessed by the ASSET Scale | Psychomotor performance is evaluated using a modified Arthroscopic Surgical Skill Evaluation Tool (ASSET). The total score ranges from 8 to 38, with higher scores indicating better surgical skill and performance. | Time Frame: Baseline (before intervention; assessment conducted after Phase 1, within up to 2 weeks) and immediately after completion of the intervention (assessment conducted after Phase 3, within up to 2 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Workload Assessed by the SURG-TLX Scale | Perceived cognitive and physical workload during the evaluation tasks is measured using an adapted Surgery Task Load Index (SURG-TLX). The questionnaire evaluates six dimensions: mental demands, physical demands, temporal demands, task complexity, situational stress, and distractions using a 5-point Likert scale. The total score ranges from 6 to 30, with higher scores indicating a higher perceived workload. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Javier P Loureiro, PhD | Universidade da Coruña | Study Director |
| Antonio J Marques, PhD | Polytechnic Institute of Porto | Study Director |
| Renato F Magalhaes, MSc | Universidade da Coruña / Polytechnic Institute of Porto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Experimental Surgery Unit, ICBAS - School of Medicine and Biomedical Sciences, University of Porto | Porto | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40627855 | Background | Magalhaes R, Lima AC, Marques A, Pereira J, Santos LL. Usefulness of Mixed Reality in Surgical Treatment: Delphi Study. J Med Internet Res. 2025 Jul 8;27:e69964. doi: 10.2196/69964. | |
| 39145896 | Background | Magalhaes R, Oliveira A, Terroso D, Vilaca A, Veloso R, Marques A, Pereira J, Coelho L. Mixed Reality in the Operating Room: A Systematic Review. J Med Syst. 2024 Aug 15;48(1):76. doi: 10.1007/s10916-024-02095-7. |
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Individual participant data will not be shared publicly to ensure the privacy and confidentiality of the participants, in accordance with the informed consent signed for this study and General Data Protection Regulation (GDPR) guidelines. Aggregate data and statistical results will be made available through publication.
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Participants are randomly assigned to one of two parallel training arms: a Control Group utilizing a traditional physical bench-model simulator, and an Experimental Group utilizing an immersive Mixed Reality (MR) simulator.
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Blinding is applied to the evaluation phases. Surgical performance videos from Phase 1 (Baseline) and Phase 3 (Post-Intervention Evaluation) are recorded and anonymized to conceal the participants' identity and group allocation. The independent expert physicians (Outcomes Assessors) score these videos using the ASSET scale without knowing whether the participant underwent traditional training or Mixed Reality training.
| Mixed Reality Simulator Training | Other | Execution of a three-session psychomotor training protocol utilizing an immersive Mixed Reality simulator that provides holographic images and a virtual monitor for visual guidance. |
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| Time Frame: Baseline (before intervention; completed immediately after Phase 1 on the same day) and immediately after completion of the intervention (completed immediately after Phase 3 on the same day) |
| Perceived Workload Assessed by the NASA-TLX Scale | Perceived workload during the Phase 2 tasks is measured using an adapted NASA Task Load Index (NASA-TLX). The questionnaire assesses six dimensions: mental demand, physical demand, temporal demand, performance, effort, and frustration. Each item is rated on a 5-point Likert scale. The total score ranges from 6 to 30, with higher scores indicating greater perceived workload. | After the conclusion of the last session of phase 2, within a maximum period of 1 week. |