Clinical Trial

Stress Reduction Using Video Googles on Patients Undergoing Vascular Surgery

Study acronym: MEP-VASC
Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated November 26, 2024 (before its estimated March 2025 completion). Its status may not reflect the trial's current state.
Summary
One treatment option of internal carotid artery stenosis is open surgical endarterectomy. The operation is frequently carried out under regional plexus anesthesia, allowing the patient to remain awake during the procedure. This approach offers the advantage of monitoring for neurological changes during carotid artery clamping, allowing the surgical team to immediately respond by placing a shunt to ensure cerebral perfusion. As a result, performing surgery under regional anesthesia provides therefor a benefit. However, for patients, the procedure, which can last up to two hours or longer in some cases, may pose a significant burden. The fixed position, inability to move, sterile drapes over the face, manipulation by the surgical team, and anxiety about potential complications are just a few of the factors that may distress patients during the operation. Increased sweating and reports of substantial subjective distress are not uncommon if the procedure is performed under local anesthesia. In many medical fields, devices and therapies are now being utilized to reduce patient stress in the perioperative setting. In procedures performed under local or regional anesthesia, such as in orthopedics or dentistry, efforts are being made to make operations more tolerable and less stressful for patients. For example, music and video goggles are employed to entertain and distract patients during the intervention. Newer approaches using video googles appear in more and more fields to reduce distress. Especially in vascular surgery and particularly in carotid surgery, the use of audiovisual distraction during the procedure has not been implemented to our knowledge, and its benefits remain undocumented. Because of the special setting and burden for the patients it is highly necessary to test these devices in carotid surgery and explore potential benefits for these patients.
Trial Details
NCT Number NCT06704230
Lead Sponsor University Hospital Augsburg
Collaborators: HappyMed GmbH (Wien, Austria)
Conditions Carotid Artery Diseases, Regional Anesthesia, Distress, Procedural
Enrollment 100 participants
Start Date 2022-09-09
Primary Completion 2025-03 (estimated)
Study Completion 2025-04 (estimated)
Updated on ClinicalTrials.gov 2024-11-26