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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
C.H.U. Poitiers
RECRUITING
Poitiers
Contact Information
Primary
Amélie PETIT
Amelie.PETIT@chu-poitiers.fr
+33 5 49 44 69 70
Time Frame
Start Date: 2026-03-03
Estimated Completion Date: 2027-09-03
Participants
Target number of participants: 90
Treatments
Experimental: In addition to the usual care, the patient will be equipped with VR headsets
In addition to the usual care, the 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.
No_intervention: The patient will receive the usual treatment under local anesthesia
The patient will receive standard care under local anesthesia with an analgesic injection (paracetamol) +/- morphine sedation (remifentanil), according to the treatment protocol and tailored to the patient.
Sponsors
Leads: Poitiers University Hospital

This content was sourced from clinicaltrials.gov