Clinical trial NCT06704230: Stress Reduction Using Video Googles on Patients Undergoing Vascular Surgery
Official title: Multimedia Patient Entertainment During Vascular Surgery Procedures in Regional Anesthesia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carotid Artery Diseases
Regional Anesthesia
Distress, Procedural
Keywords: video googles
carotid endarterectomy
distress in patients
vascular surgery
Lead sponsor: University Hospital Augsburg
Sponsor class: OTHER
Collaborators: name: HappyMed GmbH (Wien, Austria)
First posted: 2024-11-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Bloodserum cortisol levels
timeFrame: Cortisol levels are measured six times the day the procedure is performed. Starting at 6:30am, Arraiving at the OR, dermal incision, clamping the carotid artery, dermal suture, one hour after leaving the OR
measure: Heartrate
timeFrame: The heartrate is measured six times the day the procedure is performed. Starting at 6:30am, arraiving at the OR, dermal incision, clamping the carotid artery, dermal suture, one hour after leaving the OR
measure: short questionnaire on current stress
timeFrame: The questionnaire is asked six times the day the procedure is performed. Starting at 6:30am, arraiving at the OR, dermal incision, clamping the carotid artery, dermal suture, one hour after leaving the OR
measure: Richmond Agitation-Sedation Scale (RASS)
timeFrame: RASS is measured six times the day the procedure is performed.Starting at 6:30am, arraiving at the OR, dermal incision, clamping the carotid artery, dermal suture, one hour after leaving the OR
measure: Spielberger State-Trait Anxiety Inventory (STAI)
timeFrame: One Day. Day before surgery
measure: Satisfaction (patient, surgeon, anesthesia)
timeFrame: One day. After surgery, within the next 24 hours
measure: Next time again?
timeFrame: One day. After surgery, within the next 24 hours
measure: pain, distress, nervousness, fear
timeFrame: Questions are asked six times the day the procedure is performed.Starting at 6:30am, arraiving at the OR, dermal incision, clamping the carotid artery, dermal suture, one hour after leaving the OR
Secondary outcomes:
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Universitätsklinikum Augsburg
state: Bavaria
Study officials:
affiliation: Vascular Surgery Faculty of Medicine University of Augsburg, Stenglinstr. 2 86156 Augsburg
name: Alexander Hyhlik-Dürr, Prof. Dr.
role: STUDY_DIRECTOR
References: