Minimally Invasive Superficial Venous Insufficiency Surgery and Digital Sedation

Launched by GCS RAMSAY SANTÉ POUR L'ENSEIGNEMENT ET LA RECHERCHE · Jan 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how virtual reality can help reduce pain during a specific surgery for a condition called superficial venous insufficiency, which often involves varicose veins. The researchers want to see if using virtual reality can lessen the need for stronger sedation that is typically given during this procedure, allowing patients to rely more on local anesthesia (numbing only the area being treated) instead.

To participate in this study, you need to be at least 18 years old and have been diagnosed with superficial venous insufficiency that requires surgery. You should be able to understand the study details and give your consent to participate. However, some people may not be eligible, such as those who cannot use a virtual reality headset due to vision or hearing issues, or those who are pregnant or have certain medical conditions. If you choose to join the study, you'll be part of a group that explores an innovative way to make surgery more comfortable and potentially less stressful.

Gender

ALL

Eligibility 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