NCT07181434 Impact of Virtual Reality on Patient Pain During Lower Limb Revascularization Via Endovascular Surgery Under Local Anesthesia With Sedation
| NCT ID | NCT07181434 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Poitiers University Hospital |
| Condition | Peripheral Arterial Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2026-03-03 |
| Primary Completion | 2027-09-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2026-03-03 with a primary completion date of 2027-09-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07181434 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peripheral Arterial Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07181434 currently recruiting?
Yes, NCT07181434 is actively recruiting participants. Contact the research team at Amelie.PETIT@chu-poitiers.fr for enrollment information.
Where is the NCT07181434 trial being conducted?
This trial is being conducted at Poitiers, France.
Who is sponsoring the NCT07181434 clinical trial?
NCT07181434 is sponsored by Poitiers University Hospital. The trial plans to enroll 90 participants.