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Clinical Trials in France / NCT06228365
Recruiting Not applicable

Minimally Invasive Superficial Venous Insufficiency Surgery and Digital Sedation

NCT06228365 · tracked via the Priya Life Science France tracker
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
Phase
Not applicable
Started
2023-11-20
Last updated
2025-12-03

Condition(s) studied

Superficial Venous Insufficiency

Investigational drug(s) / intervention(s)

use of a device incorporating virtual reality softwareNeuroleptanalgesia

use of a device incorporating virtual reality software: use of a device incorporating virtual reality software

Neuroleptanalgesia: Usual neuroleptanalgesic treatment

Study summary

Virtual reality has been shown to reduce the pain experienced during medical procedures.

The aim of this study is to determine to what extent the use of this technique could make it possible to defer the administration of neuroleptanalgesia during the endovenous thermal treatment of superficial varicose veins in addition to local anaesthesia by tumescence.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Pain intensity assessed by NRS (numerical rating scale) — Day 1
    The intensity of maximum pain during the surgery will be assessed by numerical rating scale (NRS) graduated from 0 (no pain) to 10 (worst pain imaginable).

Trial sites (2)

FacilityCityRegionStatus
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

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Evaluation of the Effects of Virtual Reality on Preoperative Anxiety in Refractive Surgery Recruiting
Study Comparing Two Anesthetics for Arthroscopic Rotator Cuff Repair Recruiting
Evaluating the Benefit of Hypnoanalgesia Versus Neuroleptanalgesia During Hand Surgery Recruiting
Assessment of NEURO-K-STARTS Following Primary Anterior Cruciate Ligament (ACL) Reconstruction Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06228365 on ClinicalTrials.gov ↗ ← All trials in France