Stress Reduction Using Video Googles on Patients Undergoing Vascular Surgery

Официальное название

Multimedia Patient Entertainment During Vascular Surgery Procedures in Regional Anesthesia

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Bloodserum cortisol levels [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: One Day. Day before surgery]
• Satisfaction (patient, surgeon, anesthesia) [Срок оценки: One day. After surgery, within the next 24 hours]
• Next time again? [Срок оценки: One day. After surgery, within the next 24 hours]
• pain, distress, nervousness, fear [Срок оценки: 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]

Критерии участия

Критерии включения

• Planed carotid endarterectomy in local anesthesia

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 1 центр

• Universitätsklinikum Augsburg — Augsburg

Публикации

• 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

Идентификаторы

NCT: NCT06704230 · 21-1199

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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