Minimally invasive surgery for varicose veins using virtual reality sedation
Official title: Efficacy of Digital Sedation Compared With Neuroleptanalgesia in Percutaneous Outpatient Surgery for Superficial Venous Insufficiency
Run by GCS Ramsay Santé pour l'Enseignement et la Recherche · NCT06228365 · Data updated 2026-11-12
This study is testing if using virtual reality for sedation during varicose vein surgery can help reduce pain and the need for stronger sedation compared to traditional methods.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche Academic / other |
| Locations | 2 sites (Saint-Jean and 1 other locations) |
| Status | Recruiting |
| Started | November 20, 2023 |
| Main results expected | May 31, 2026 |
| Study ends | June 30, 2026 |
| Registry record updated | December 3, 2025 |
| Trial ID | NCT06228365 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are outpatients aged 18 or older with superficial venous insufficiency requiring surgical intervention and sedation.
✕Probably not a fit
Patients with contraindications to local anesthesia or the sedatives used, as well as those with significant sensory impairments or cognitive issues, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of virtual reality as a sedation method during the endovenous thermal treatment of superficial varicose veins, comparing it to traditional neuroleptanalgesia. It is a prospective, randomized, open-label trial involving 200 patients, assessing pain levels immediately after the procedure. The goal is to determine if virtual reality can reduce pain sufficiently to allow for less sedation while maintaining patient comfort. Participants will be monitored for a maximum of two days.
Why it matters
Potential benefit: If successful, this approach could reduce the need for stronger sedatives during varicose vein surgery, leading to a safer and more comfortable experience for patients.
How similar studies have gone: Other studies have shown promise in using virtual reality for pain management in medical procedures, suggesting this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient aged 18 or over, who has read and signed the consent form for participation in the study after a reflection period (approximately 1 hour). * Outpatients with superficial venous insufficiency for which a surgical indication has been given * Patient requiring sedation associated with local anesthesia Exclusion Criteria: * Contraindication to local anesthesia or any of the sedatives used in the protocol * Hearing or visual impairment contraindicating use of the virtual reality headset * Pregnant or breast-feeding patients * Unbalanced epilepsy * Patients under court protection, guardianship or curatorship * Patients not affiliated to the French social security system * Patient unable to understand informed information and/or give written informed consent: dementia, psychosis, disturbed consciousness, non-French-speaking patient
Where it's running
-
Clinique de l'Union
Saint-Jean, France Recruiting -
Hôpital Privé de Villeneuve d'Ascq - Ramsay Santé 20 Av. de la Reconnaissance, 59650 Villeneuve-d'Ascq
Villeneuve-d'Ascq, France Recruiting
Study contacts
- Principal investigator: Lauranne MATRAY, MD — Clinique de l'Union
- Study coordinator: Lauranne MATRAY, MD
- Email: dr.lmatray.union@gmail.com
- Phone: 05 61 37 81 81
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.