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

RecruitingNAAges 18 Years - anyAllPoitiers University Hospital
NCT07181434 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • The patient will be equipped with VR headsets
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Where

1 site
C.H.U. Poitiers
Poitiers, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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