Stress Reduction Using Video Googles on Patients Undergoing Vascular Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Augsburg

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Planed carotid endarterectomy in local anesthesia

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • video googles

    Device

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Intervention group (+ video googles)Experimental treatment 1 intervention
Group B: Control group (- video googles)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Bloodserum cortisol levels

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

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
2

Heartrate

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

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
3

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)

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
4

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)

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Augsburg

Lead sponsor

HappyMed GmbH (Wien, Austria)

Collaborator