Impact of Virtual Reality on Patient Pain During Lower Limb Revascularization Via Endovascular Surgery Under Local Anesthesia With Sedation

The prevalence of peripheral arterial disease (PAD) increases with age. In high-income countries, it is 5% between the ages of 45 and 49, and 18% after the age of 85. In France, nearly 1 million people are affected by this disease.

In addition to medical treatment, endovascular procedures can be performed, depending on the stage of the disease, to prevent complications and/or sequelae (relapse, functional loss of the affected limb, amputation, death), but also to relieve pain. This is a minimally invasive procedure most often performed under local anesthesia (LA), sometimes with the administration of sedatives (morphine and analgesics) to relieve pain and reduce anxiety related to the procedure.

Local anesthesia causes discomfort related to the operating environment (low temperature, harsh lighting, noise, supine position, arms along the body, cold, hard, narrow table), impacting patient cooperation and making the procedure difficult, with the need to take multiple X-rays and reinject potentially nephrotoxic contrast agents. It can lead to the procedure being stopped, with serious consequences (postponement, persistent or even worsening pain, amputation, death).

Non-pharmacological methods such as virtual reality (VR) are increasingly being used as an alternative to general anesthesia and excessive opioid use.

It has proven effective in managing pain and anxiety during various medical, surgical, and endovascular procedures. Its high-quality graphics immerse the patient; hypnotic speech and relaxing elements capture the patient's attention; breathing exercises help manage stress; and relaxing music creates a soothing atmosphere. This support ensures greater mental and physical comfort by reducing pain and anxiety.

The hypothesis is that VR could reduce pain during lower limb revascularization by endovascular surgery.

• Anxiety will be measured at Baseline and just after the intervention using an EN ranging from 0 for "no anxiety" to 10 for "maximum imagined anxiety" [Time frame: At Baseline and just after the intervention of lower limb revascularization through endovascular surgery]
• Systolic Blood Pressure (SBP) in mmHg [Time frame: At Baseline before the procedure of lower limb revascularization through endovascular surgery, upon arrival in the operating room, then every 15 minutes until the end of the procedure.]
• Diastolic Blood Pressure (DBP) in mmHg [Time frame: At Baseline before the procedure of lower limb revascularization through endovascular surgery, upon arrival in the operating room, then every 15 minutes until the end of the procedure.]
• Heart Rate (HR) in cycles/min [Time frame: At Baseline before the procedure of lower limb revascularization through endovascular surgery, upon arrival in the operating room, then every 15 minutes until the end of the procedure.]
• Respiratory Rate (RR) in Beats Per Minute (BPM) [Time frame: At Baseline before the procedure of lower limb revascularization through endovascular surgery, upon arrival in the operating room, then every 15 minutes until the end of the procedure.]
• Total doses and classes of analgesics, morphine derivatives, and anesthetics consumed [Time frame: During the procedure of lower limb revascularization through endovascular surgery]
• The dose of X-ray radiation [Time frame: During the procedure of revascularization of the lower limbs by endovascular surgery]
• The volume of contrast medium delivered [Time frame: During the procedure of revascularization of the lower limbs by endovascular surgery]
• The difference between the duration of the procedure as perceived by the patient and the actual duration of the procedure in minutes [Time frame: At the end of the procedure of revascularization of the lower limbs by endovascular surgery]
• The success rate of the procedure [Time frame: At the end of the procedure of revascularization of the lower limbs by endovascular surgery]
• Proportion of patients who kept the virtual reality headsets on throughout the procedure [Time frame: Throughout the procedure of lower limb revascularization through endovascular surgery]
• VR satisfaction score, rated on a scale from 0 for "not at all satisfied" to 10 for "completely satisfied." [Time frame: At the end of the procedure of lower limb revascularization through endovascular surgery]