See if virtual reality can ease pain during a less invasive leg procedure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study investigates the use of virtual reality (VR) headsets to reduce pain and anxiety during endovascular revascularization of the lower limb performed under local anesthesia with sedation. Participants are adults with PAD scheduled for this procedure and able to understand French. The VR headset is used during the procedure to create an immersive environment that may distract from discomfort and potentially reduce the need for analgesics. The study will observe pain levels, patient experience, and any VR-related safety issues. No results are provided here, but the aim is to see if VR can improve patient comfort and cooperation during the intervention.

Why it matters

Who can join: the full rules

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.

Where it's running

• C.H.U. Poitiers
  Poitiers, France Recruiting

Study contacts

• Study coordinator: Amélie PETIT
• Email: Amelie.PETIT@chu-poitiers.fr
• Phone: +33 5 49 44 69 70

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.