Clinical Competence, Surgical Education
Conditions
Keywords
Mixed Reality, Arthroscopy, Surgical Simulation, Psychomotor Skills, Medical Education, Knee Joint
Brief summary
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).
Detailed description
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.
Interventions
OTHERTraditional Simulator Training
Execution of a three-session psychomotor training protocol utilizing a physical bench-model simulator with an external video monitor for visual guidance.
OTHERMixed Reality Simulator Training
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.
Sponsors
Universidade da Coruña
Polytechnic Institute of Porto
Universidade do Porto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participants aged 18 years or older. * Medical students or junior orthopedic surgery trainees. * Novices in arthroscopic procedures (no prior practical experience in arthroscopy). * Voluntary agreement to participate and sign the informed consent form.
Exclusion criteria
* Any visual, cognitive, or physical impairment that prevents the proper execution of the simulated psychomotor tasks or the use of the MR glasses. * Inability to attend all three scheduled training sessions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychomotor Skill Performance Assessed by the ASSET Scale | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Workload Assessed by the SURG-TLX Scale | 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 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. |
| Perceived Workload Assessed by the NASA-TLX Scale | After the conclusion of the last session of phase 2, within a maximum period of 1 week. | 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. |
Countries
Portugal
Contacts
STUDY_DIRECTORJavier P Loureiro, PhD
Universidade da Coruña
STUDY_DIRECTORAntonio J Marques, PhD
Polytechnic Institute of Porto
PRINCIPAL_INVESTIGATORRenato F Magalhaes, MSc
Universidade da Coruña / Polytechnic Institute of Porto
Outcome results
None listed