Status:

COMPLETED

Surgery and Virtual Reality: Interest of Virtual Reality in Oncology for Procedures Under Local Anesthesia in the Operating Room

Lead Sponsor:

Institut Cancerologie de l'Ouest

Conditions:

Cancer

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Virtual Reality (VR) is an interactive and immersive technology that allows you to evolve in a three-dimensional environment created by computer. It appeals to the senses of people by reproducing univ...

Detailed Description

Description of the modalities for recruiting : During the preoperative consultation, the surgeon or anesthesiologist presents the study to the patient with a cancer requiring a surgery under local an...

Eligibility Criteria

Inclusion

  • Patient aged 18 or more
  • Patient eligible for surgery under local anaesthesia in the operating room
  • Written informed consent obtained from the patient
  • Patient has valid health insurance

Exclusion

  • Surgical procedure requiring complementary anaesthetic products such as intravenous sedation, nitrous oxide
  • Patient requiring an epidural, a paravertebral block
  • Patient with known allergy(ies) to local anaesthetics
  • Patient with schizophrenia, seizure disorder
  • For the investigation site with PhysioDoloris monitor (MDMS): Patient with contraindications to ANI monitoring:
  • Known heart rhythm disorder (complete arrhythmia by atrial fibrillation) Pacemaker Apnea
  • Administration of a sedative premedication in the 6 hours before the surgery
  • Visually or hearing impaired patient without a hearing aid
  • Patient deprived of liberty or under guardianship

Key Trial Info

Start Date :

June 16 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 27 2023

Estimated Enrollment :

42 Patients enrolled

Trial Details

Trial ID

NCT05287854

Start Date

June 16 2022

End Date

June 27 2023

Last Update

October 7 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

ICO

Angers, France, 49055

2

ICO

Saint-Herblain, France, 44805