About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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);
Trial design
Parallel
Treatments tested in this trial
The patient will be equipped with VR headsets
DeviceThe 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 groups
Trial outcomes
Primary outcomes
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)
Secondary outcomes
The difference in anxiety measures assessed at baseline and just after the intervention
Anxiety will be measured at baseline and just after the intervention using a numerical rating scale ranging from 0 for "no anxiety" to 10 for "maximum imagined anxiety": a quick, easy-to-use scale that correlates strongly with Spielberger's STAI scale (Benotsch et al., 2000).
Systolic Blood Pressure (SBP) in mmHg
Diastolic Blood Pressure (DBP) in mmHg
Heart Rate (HR) in cycles/min
Sponsors and contacts
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