NCT07181434

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Poitiers University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The prevalence of peripheral arterial disease (PAD) increases with age 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. Non-pharmacological methods such as virtual reality (VR) are increasingly being used as an alternative to general anesthesia and excessive opioid use. The hypothesis is that VR could reduce pain during lower limb revascularization by endovascular surgery.

Detailed description

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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	The patient will be equipped with VR headsets	The patient will be equipped with VR headsets showing one of the six scenes from the HealthyMind® program in 3D, accompanied by hypnotic speech during the procedure.

Timeline

• Start date: 2025-10-15
• Primary completion: 2027-04-15
• Completion: 2027-04-15
• First posted: 2025-09-18
• Last updated: 2025-09-18

Locations

1 site across 1 country: France