Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06704230

Stress Reduction Using Video Googles on Patients Undergoing Vascular Surgery

Led by University Hospital Augsburg · Updated on 2024-11-26

100

Participants Needed

1

Research Sites

133 weeks

Total Duration

On this page

Sponsors

U

University Hospital Augsburg

Lead Sponsor

H

HappyMed GmbH (Wien, Austria)

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Stress Reduction Using Video Googles on Patients Undergoing Vascular Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Planned carotid endarterectomy in local anesthesia
Not Eligible

You will not qualify if you...

  • Unable to communicate due to stroke or language barrier
  • Dementia or neurological damage affecting understanding or questionnaire responses
  • Taking steroid medications

AI-Screening

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Trial Site Locations

Total: 1 location

1

Universitätsklinikum Augsburg

Augsburg, Bavaria, Germany, 86156

Actively Recruiting

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Research Team

H

Hagen Kerndl

CONTACT

T

Thomas Millian

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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