Stress Reduction Using Video Googles on Patients Undergoing Vascular Surgery (MEP-VASC)

University Hospital Augsburg

Status: Enrolling

Conditions: Distress, Procedural; Regional Anesthesia; Carotid Artery Diseases

Treatments: Device: video googles

Study type: Interventional

Funder types: Other

Identifiers

NCT06704230

21-1199

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Planed carotid endarterectomy in local anesthesia

Exclusion criteria

• patients which are not able to communicate because of stroke or language barrier,
• Dementia or neurological damage which impairs answering questionnaires or the understanding of the situation during surgery
• medication with steroids

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Intervention group (+ video googles)

Experimental group

Description:

Patients undergoging surgery, video googles are used during surgery to reduce patient distress

Treatment:

Device: video googles

Control group (- video googles)

No Intervention group

Description:

Patients undergo surgery in the same way, no video googles or other devices for the reduction of distress is used