NCT06704230 Stress Reduction Using Video Googles on Patients Undergoing Vascular Surgery
| NCT ID | NCT06704230 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Augsburg |
| Condition | Carotid Artery Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-09-09 |
| Primary Completion | 2025-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2022-09-09 with a primary completion date of 2025-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Alexander Hyhlik-Dürr, Prof. Dr.
STUDY DIRECTOR
Vascular Surgery Faculty of Medicine University of Augsburg, Stenglinstr. 2 86156 Augsburg
Frequently Asked Questions
Who can join the NCT06704230 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Carotid Artery Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06704230 currently recruiting?
Yes, NCT06704230 is actively recruiting participants. Contact the research team at hagen.kerndl@uk-augsburg.de for enrollment information.
Where is the NCT06704230 trial being conducted?
This trial is being conducted at Augsburg, Germany.
Who is sponsoring the NCT06704230 clinical trial?
NCT06704230 is sponsored by University Hospital Augsburg. The principal investigator is Alexander Hyhlik-Dürr, Prof. Dr. at Vascular Surgery Faculty of Medicine University of Augsburg, Stenglinstr. 2 86156 Augsburg. The trial plans to enroll 100 participants.