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Stress Reduction Using Video Googles on Patients Undergoing Vascular Surgery

NCT06704230 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-11-26

No results posted yet for this study

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.

Conditions

  • Carotid Artery Diseases
  • Regional Anesthesia
  • Distress, Procedural

Interventions

DEVICE

video googles

Patients undergoing surgery use video googles and a headphone to distract from surgery

Sponsors & Collaborators

  • HappyMed GmbH (Wien, Austria)

    collaborator UNKNOWN

  • University Hospital Augsburg

    lead OTHER

Principal Investigators

  • Alexander Hyhlik-Dürr, Prof. Dr. · Vascular Surgery Faculty of Medicine University of Augsburg, Stenglinstr. 2 86156 Augsburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-09
Primary Completion
2025-03-31
Completion
2025-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06704230 on ClinicalTrials.gov