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Mixed Reality vs. Traditional Arthroscopic Simulation

10. juni 2026 opdateret af: Javier Pereira, Universidade da Coruña

Comparative Effectiveness of Mixed Reality Versus Traditional Simulation in Arthroscopic Surgical Training: A Parallel-Group Randomized Trial

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).

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

25

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Portugal
      • Porto, Portugal
        • Experimental Surgery Unit, ICBAS - School of Medicine and Biomedical Sciences, University of Porto

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Traditional Simulator Group (TSG)
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.
Andet: Traditional Simulator Training
Execution of a three-session psychomotor training protocol utilizing a physical bench-model simulator with an external video monitor for visual guidance.
Eksperimentel: Mixed Reality Simulator Group (MRSG)
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.
Andet: Mixed 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Psychomotor Skill Performance Assessed by the ASSET Scale
Tidsramme: 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.
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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Perceived Workload Assessed by the SURG-TLX Scale
Tidsramme: 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.
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
Tidsramme: 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.
After the conclusion of the last session of phase 2, within a maximum period of 1 week.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universidade da Coruña

Samarbejdspartnere

Universidade do Porto
Polytechnic Institute of Porto

Efterforskere

  • Studieleder: Javier P Loureiro, PhD, Universidade da Coruña
  • Studieleder: Antonio J Marques, PhD, Polytechnic Institute of Porto
  • Ledende efterforsker: Renato F Magalhaes, MSc, Universidade da Coruña / Polytechnic Institute of Porto

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. oktober 2025

Primær færdiggørelse (Anslået)

1. juni 2026

Studieafslutning (Anslået)

1. juni 2026

Datoer for studieregistrering

Først indsendt

5. juni 2026

Først indsendt, der opfyldte QC-kriterier

10. juni 2026

Først opslået (Faktiske)

15. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • MR-ARTHRO-2025-01
  • 2025/CE/P13 (Anden identifikator: Comissao de Etica ICBAS)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Kirurgisk Uddannelse

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