No clinical presentation
Conditions
Interventions
Group 1: The surgeon conducts the study using an HMD and completes questionnaires at the end, as described under primary endpoints. Patients undergo surgery in accordance with the guidelines or their
Sponsors
Klinik für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie, Universitätsklinikum Essen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: ? Clinical staff with surgical experience who are actively involved in performing the procedures. ? Written consent to participate in the study and to use a head-mounted display (HMD). ? Sufficient knowledge of German to understand the informed consent process and sufficient knowledge of English to complete standardized questionnaires (such as SUS, ISONORM 9241-110-S). ? Prior brief trial use of the HMD outside the operating room without any relevant complaints (e.g., severe nausea, dizziness, disorientation, headaches).
Exclusion criteria
Exclusion criteria: ? No consent or withdrawal of consent to participate in the study or use the HMD. ? Insufficient language skills (German/English) to understand the informed consent form and complete the questionnaires. ? Occurrence of relevant symptoms (e.g., motion sickness, pronounced visual fatigue, disorientation, headaches) during the preceding test use; in this case, the combination of this surgeon and the respective HMD model will not be used in the operating room. ? Should subjective symptoms or impairments arise during the procedure that, in the surgeon’s assessment, could compromise the safe performance of the surgery, the use of the HMD by that individual will be terminated immediately; the headset will be removed, and the procedure will continue without the HMD according to routine protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| o Usability of the HMD quantified using the overall score from established questionnaires such as the System Usability Scale (SUS) following intraoperative use of the HMDs. o Acceptance and integration into the surgical workflow: Assessed using ISONORM 9241-110-S as well as supplementary evaluation items (e.g., willingness to reuse, perceived support during the procedure) and standardized questions regarding perceived advantages and disadvantages, as well as desired additional functions of the HMDs. o Feasibility in everyday clinical practice: Proportion of procedures in which the HMD could be used intraoperatively as planned without interruption due to technical problems or complaints (e.g., cybersickness, visual fatigue). | — |
Secondary
| Measure | Time frame |
|---|---|
| o Comparison of HMD models: A subjective comparison of various HMD models (such as HoloLens 2, Meta Quest 3, and Apple Vision Pro) in terms of image quality, perceived latency, ergonomics, and comfort, as well as user preference (overall preference of the surgeons). o Technical performance parameters of image transmission: average and maximum streaming latency, stability of image playback (e.g., stuttering, image dropouts, dropped frames), stability and quality of the network connection (e.g., connection drops, necessary restarts). Exploratory clinical observational data: average surgery duration with and without HMD (comparison of the average surgery duration for procedures using HMD with corresponding procedures without HMD based on existing surgical documentation), Frequency and duration of procedure interruptions due to technical factors, clinical parameters routinely collected and documented as part of standard care (e.g., blood loss and blood pressure). | — |
Countries
Germany
Outcome results
None listed