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

Poitiers University Hospital

Status: Not yet enrolling

Conditions: Peripheral Arterial Disease

Treatments: Device: The patient will be equipped with VR headsets

Study type: Interventional

Funder types: Other

Identifiers

NCT07181434

REVDOU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient suffering from PAD, scheduled to undergo endovascular surgery for lower limb revascularization under local anesthesia combined with sedation.
• Age ≥ 18 years.
• Patient who understands and speaks French.
• Patient covered by social security or covered through a third party.
• Free subject, without guardianship, curatorship, or subordination.
• Patient who has given their free and informed consent.

Exclusion criteria

• Patients with contraindications to VR headsets (mono- or binocular blindness, epilepsy, migraines, psychiatric disorders, pacemakers, hearing aids, defibrillators, recent injuries to the eyes, face, or scalp that prevent comfortable use of the headsets, etc.).
• Patients with suspected intolerance to VR headsets (sensitivity to motion sickness in cars, history of balance or eye disorders, etc.);
• Previous bad experience with VR headsets;
• Patients undergoing local regional anesthesia (LRA);
• Persons requiring enhanced protection, namely persons deprived of their liberty by judicial or administrative decision, pregnant women, and finally patients in life-threatening situations.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

90 participants in 2 patient groups

In addition to the usual care, the patient will be equipped with VR headsets

Experimental group

Description:

In addition to the usual care, 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.

Treatment:

Device: The patient will be equipped with VR headsets

The patient will receive the usual treatment under local anesthesia

No Intervention group

Description:

The patient will receive standard care under local anesthesia with an analgesic injection (paracetamol) +/- morphine sedation (remifentanil), according to the treatment protocol and tailored to the patient.