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NCT Number: NCT06704230

Stress Reduction Using Video Googles on Patients Undergoing Vascular Surgery

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.

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Key information

Conditions

Carotid Artery Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Distress, Procedural Nervous System Diseases Regional Anesthesia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Augsburg

Augsburg, Bavaria, 86156, Germany

Location status: Recruiting

Location contact

Hagen Kerndl

CONTACT

[email protected]

+49 821 40 2655

Hagen Kerndl

PRINCIPAL_INVESTIGATOR

Thomas Millian

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

video googles

Device

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

Other names: multimedial distraction

Primary outcomes

  1. Bloodserum cortisol levels

    Time frame: 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

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

  2. Heartrate

    Time frame: 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

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

  3. short questionnaire on current stress

    Time frame: 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

    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)

  4. Richmond Agitation-Sedation Scale (RASS)

    Time frame: 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

    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)

  5. Spielberger State-Trait Anxiety Inventory (STAI)

    Time frame: One Day. Day before surgery

    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.

  6. Satisfaction (patient, surgeon, anesthesia)

    Time frame: One day. After surgery, within the next 24 hours

    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.

  7. Next time again?

    Time frame: One day. After surgery, within the next 24 hours

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

  8. pain, distress, nervousness, fear

    Time frame: 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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Hagen Kerndl

CONTACT

[email protected]

+49 821 400 2655

Thomas Millian

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital Augsburg

Other

Collaborators

  • HappyMed GmbH (Wien, Austria)

Registry information

Official study title

Multimedia Patient Entertainment During Vascular Surgery Procedures in Regional Anesthesia

Acronym: MEP-VASC

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 26, 2024
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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