Stress Reduction Using Video Googles on Patients Undergoing Vascular Surgery (MEP-VASC)

Multimedia Patient Entertainment During Vascular Surgery Procedures in Regional Anesthesia

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.

Study Overview

• Status: Recruiting
• Conditions: Carotid Artery Diseases; Regional Anesthesia; Distress, Procedural
• Intervention / Treatment: Device: video googles

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hagen Kerndl; Phone Number: +49 821 400 2655; Email: hagen.kerndl@uk-augsburg.de
• Study Contact Backup: Name: Thomas Millian; Email: thomas.millian@uk-augsburg.de

Study Locations

• Germany
  • Bavaria
    • Augsburg, Bavaria, Germany, 86156
      • Recruiting
      • Universitätsklinikum Augsburg
      • Contact: Hagen Kerndl; Phone Number: +49 821 40 2655; Email: hagen.kerndl@uk-augsburg.de
      • Contact: Thomas Millian
      • Principal Investigator: Hagen Kerndl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group (+ video googles); Patients undergoging surgery, video googles are used during surgery to reduce patient distress	Device: video googles; Patients undergoing surgery use video googles and a headphone to distract from surgery; Other Names: multimedial distraction
No Intervention: Control group (- video googles); Patients undergo surgery in the same way, no video googles or other devices for the reduction of distress is used

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital Augsburg
• Collaborators: HappyMed GmbH (Wien, Austria)
• Investigators: Study Director: Alexander Hyhlik-Dürr, Prof. Dr., Vascular Surgery Faculty of Medicine University of Augsburg, Stenglinstr. 2 86156 Augsburg

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2022
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: September 25, 2024
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Estimated): November 26, 2024

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 22, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: carotid endarterectomy; vascular surgery; video googles; distress in patients
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Carotid Artery Diseases
• Other Study ID Numbers: 21-1199

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No