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

NCT07181434 | Recruiting

• 1 other identifier: REVDOU
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Arterial Disease

Keywords

Virtual reality; pain management; virtual reality headset

Outcome Measures

Primary Outcomes (1)

• The maximum level of pain experienced by the patient during the procedure

  The maximum level of pain will be assessed at the the end of the procedure using a numerical rating scale ranging from 0 (no pain) to 10 (worst pain imaginable)

  At the end of the revascularization procedure

Secondary Outcomes (15)

• The difference in anxiety measures assessed at baseline and just after the intervention

  At Baseline and just after the intervention of lower limb revascularization through endovascular surgery

• Systolic Blood Pressure (SBP) in mmHg

  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

  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

  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 Breaths Per Minute (BPM)

  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.

Study Arms (2)

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

EXPERIMENTAL

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.

Device: The patient will be equipped with VR headsets

The patient will receive the usual treatment under local anesthesia

NO INTERVENTION

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.

Interventions

The patient will be equipped with VR headsets DEVICE

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

C.H.U. Poitiers

Poitiers, 86000, France

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease; Agnosia

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Amélie PETIT

CONTACT

+33 5 49 44 69 70; Amelie.PETIT@chu-poitiers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: September 18, 2025
• Study Start: March 3, 2026
• Primary Completion (Estimated): September 3, 2027
• Study Completion (Estimated): September 3, 2027
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)