Status:
NOT_YET_RECRUITING
Impact of Virtual Reality on Patient Pain During Lower Limb Revascularization Via Endovascular Surgery Under Local Anesthesia With Sedation
Lead Sponsor:
Poitiers University Hospital
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 com...
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 peopl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 15 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT07181434
Start Date
October 15 2025
End Date
April 15 2027
Last Update
September 18 2025
Active Locations (1)
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1
C.H.U. Poitiers
Poitiers, France, 86000