Stress Reduction Using Video Googles on Patients Undergoing Vascular Surgery

NCT06704230 | Recruiting

• 1 other identifier: 21-1199
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Artery Diseases; Regional Anesthesia; Distress, Procedural

Keywords

video googles; carotid endarterectomy; distress in patients; vascular surgery

Outcome Measures

Primary Outcomes (8)

• Bloodserum cortisol levels

  cortisol levels in the blood are measured on six specific times in the perioperative setting

  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

• Heartrate

  The heart rate is measured on six specific times in the perioperative setting

  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

• short questionnaire on current stress

  The short questionnaire on current stress; is measured on six specific times in the perioperative setting. It is a validated score to measure actual stress, there are 6 items, with 6 a scale one to six. The minimal score is 6 (low distress) and 36 (high distress)

  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

• Richmond Agitation-Sedation Scale (RASS)

  TheRichmond Agitation-Sedation Scale (RASS) is measured on six specific times in the perioperative setting. It is a score typically used in anesthesia to measure agitation and sedation. The scale is from +4 (aggressive) over 0 (awake and calm) to -5 (deeply sleeping, not awakable)

  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

• Spielberger State-Trait Anxiety Inventory (STAI)

  This questionnaire ist is used to measure general and anxiety related to the current situation (upcoming surgery) Used are two questionnaires with 20 items each, after recoding the answers there is a numeric value for each questionnaire. High values suggest a high feeling of fear, low values, a low feeling of fear.

  One Day. Day before surgery

• Satisfaction (patient, surgeon, anesthesia)

  After completing the surgery, all participation parties (patient, surgery and anesthesia) are asked to rate the surgery regarding to calmness of the patient, pain and distress. A numeric rating scale (0-10) is used.

  One day. After surgery, within the next 24 hours

• Next time again?

  Patients in the interventional group are asked, if the would like to use the video googles again in case of an other surgery

  One day. After surgery, within the next 24 hours

• pain, distress, nervousness, fear

  patients are asked if the feel one of the above (using no \[1\] - rather no \[2\] - not sure \[3\] - rather yes \[4\] - yes\[5\]) six specific times in the perioperative setting. For each quality (pain, distress, nervousness, fear) there is measured an individual value

  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

Study Arms (2)

Intervention group (+ video googles)

EXPERIMENTAL

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

Device: video googles

Control group (- video googles)

NO INTERVENTION

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

Interventions

video googles DEVICE

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

Also known as: multimedial distraction

Intervention group (+ video googles)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planed carotid endarterectomy in local anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Augsburg: lead
• HappyMed GmbH (Wien, Austria): collaborator

Study Sites (1)

Universitätsklinikum Augsburg

Augsburg, Bavaria, 86156, Germany

RECRUITING

Related Publications (1)

• Kerndl H, Millian TP, Gurtler K, Hyhlik-Duerr A. Measuring Stress Reduction in Patients Receiving Multimedia Entertainment During Vascular Surgery Under Regional Anesthesia: Protocol for a Randomized Controlled Study. JMIR Res Protoc. 2025 Jul 11;14:e70597. doi: 10.2196/70597.

  PMID: 40644688 DERIVED

MeSH Terms

Conditions

Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Alexander Hyhlik-Dürr, Prof. Dr.

  Vascular Surgery Faculty of Medicine University of Augsburg, Stenglinstr. 2 86156 Augsburg

  STUDY DIRECTOR

Central Study Contacts

Hagen Kerndl

CONTACT

+49 821 400 2655; hagen.kerndl@uk-augsburg.de

Thomas Millian

CONTACT

thomas.millian@uk-augsburg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: November 26, 2024
• Study Start: September 9, 2022
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: November 26, 2024

Record last verified: 2024-11

Locations

DE (1)