Multimedia Patient Entertainment During Vascular Surgery Procedures in Regional Anesthesia

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Planed carotid endarterectomy in local anesthesia

Locations
Other Locations
Germany
Universitätsklinikum Augsburg
RECRUITING
Augsburg
Contact Information
Primary
Hagen Kerndl
hagen.kerndl@uk-augsburg.de
+49 821 400 2655
Backup
Thomas Millian
thomas.millian@uk-augsburg.de
Time Frame
Start Date: 2022-09-09
Estimated Completion Date: 2025-04
Participants
Target number of participants: 100
Treatments
Experimental: Intervention group (+ video googles)
Patients undergoging surgery, video googles are used during surgery to reduce patient distress
No_intervention: Control group (- video googles)
Patients undergo surgery in the same way, no video googles or other devices for the reduction of distress is used
Related Therapeutic Areas
Sponsors
Collaborators: HappyMed GmbH (Wien, Austria)
Leads: University Hospital Augsburg

This content was sourced from clinicaltrials.gov