Ergonomic Evaluation of Microscopic Ear Surgery With Exoskeleton: A Single Site Non-blinded Study (ExoskeletonEar)
The goal of this observational study is to learn whether an exoskeleton system can reduce musculoskeletal strain and pain during microscopic ear surgery in ENT surgeons performing tympanomastoid and related microscopic ear procedures. The main questions it aims to answer are:
Does the use of an exoskeleton reduce musculoskeletal strain (measured via surface EMG activity) during surgery? Does the use of an exoskeleton reduce subjective pain scores in the neck, back, and shoulders during surgery?
Researchers will compare surgeries performed with the exoskeleton versus surgeries performed without the exoskeleton to see if it reduces strain, muscle activity, and pain levels.
Participants will:
Perform microscopic ear surgeries with and without the exoskeleton system Wear surface EMG electrodes on the neck, back, and shoulders to record muscle activity Provide subjective pain/strain scores at regular intervals (every 5 minutes) during surgery Follow standard surgical preparation and positioning procedures before data collection begins
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Toral Odedra
- E-mail: toral.odedra@nhs.net
Sauvegarde des contacts de l'étude
- Nom: Ananth Vijendren, BM, FRCS (ORL-HNS), PhD
- Numéro de téléphone: +441438288019
- E-mail: Ananth.vijendren1@nhs.net
Lieux d'étude
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Hertfordshire
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Stevenage, Hertfordshire, Royaume-Uni, SG1 4AB
- Recrutement
- Lister Hospital, East and North Hertfordshire Teaching NHS Trust
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Contact:
- Ananth Vijendren
- Numéro de téléphone: +441438285421
- E-mail: ananth.vijendren1@nhs.net
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
The study population consists of ENT surgeons who routinely perform microscopic ear surgeries, including tympanomastoid procedures and hearing implant operations. Participants are clinicians working within the ENT department who are willing to undergo surface EMG monitoring and use the exoskeleton support system during live surgical procedures.
Eligible participants must have experience in microscopic ear surgery and no pre-existing musculoskeletal conditions that would limit their ability to perform surgery or safely use the exoskeleton.
La description
Inclusion Criteria:
- ENT surgeons who perform a range of microscopic ear surgery including tympanomastoid surgery and hearing implants.
- Willing to participate with surface EMG (sEMG) monitoring and utilise the Ottobock exoskeleton
Exclusion Criteria:
- Pre-existing musculoskeletal problems that limits procedures under microscope and tympanomastoid surgery
- Unable to perform surgery using the exoskeleton
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: CROSS_SECTIONAL
Cohortes et interventions
Groupe / Cohorte |
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With Exoskeleton
With Exoskeleton: ENT surgeons performing microscopic ear surgery while wearing the exoskeleton support system. During procedures, participants will have surface EMG electrodes placed on the neck, back, and shoulders to measure muscle activity, and will report subjective pain/strain scores at regular intervals. |
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Without Exoskeleton
Without Exoskeleton: ENT surgeons performing microscopic ear surgery under standard conditions without the exoskeleton. The same protocol will be followed, including surface EMG monitoring and regular subjective pain/strain assessments, to allow comparison with the intervention group. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Change in Visual Analogue Scale (VAS) Score for Musculoskeletal Strain
Délai: From the start of each operation to the end of the surgical procedure, with assessments every 5 minutes
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Difference in participant-reported musculoskeletal strain during microscopic tympanomastoid surgery performed with and without the exoskeleton. Strain will be assessed using a Visual Analogue Scale (VAS) at 5-minute intervals throughout each operation. |
From the start of each operation to the end of the surgical procedure, with assessments every 5 minutes
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Difference in Surface Electromyography (sEMG) Amplitude (% Change From Rest)
Délai: From the start of each operation to the end of the surgical procedure.
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Difference in muscle activity, measured using surface electromyography (sEMG), during microscopic tympanomastoid surgery performed with and without the exoskeleton. Results will be expressed as percentage change from resting sEMG amplitude in the neck, shoulder and back muscles. |
From the start of each operation to the end of the surgical procedure.
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Difference in Maximum Surface Electromyography (sEMG) Amplitude
Délai: From the start of each operation to the end of the surgical procedure.
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Difference in maximum muscle activity, measured using surface electromyography (sEMG), during microscopic tympanomastoid surgery performed with and without the exoskeleton. Maximum sEMG amplitude will be assessed in the neck, shoulder and back muscles |
From the start of each operation to the end of the surgical procedure.
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Ananth Vijendren, East and North Hertfordshire Teaching NHS Trust
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- RD2025-61
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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