RecruitingNot ApplicableNCT07013695

Evaluation of the Impact of Virtual Reality on Sedation Use in Patients Undergoing Regional Anesthesia for Scheduled Orthopedic Surgery


Sponsor

Centre Hospitalier Eure-Seine

Enrollment

164 participants

Start Date

Jul 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The VIRTUALR study evaluates the effect of virtual reality combined with hypnosis on anxiety in patients undergoing orthopedic surgery under regional anesthesia. Patients are randomly assigned to two groups: one group receiving virtual reality and a control group without the device. Anxiety and satisfaction questionnaires are used to compare the two groups.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Signed informed consent
  • Patient affiliated with or benefiting from a social security system
  • Patient aged 18 years or older
  • Patient requiring regional anesthesia for scheduled orthopedic surgery of the upper or lower limb

Exclusion Criteria6

  • Patient refusal to participate in the study
  • Device interfering with the surgical or anesthetic procedure
  • Premedication before arrival in the operating room
  • Psychiatric or cognitive disorders, communication disorders
  • Patient unable to understand the study (language barrier, psychological issues)
  • Emergency surgery

Interventions

DEVICEVirtual reality headset

Patients in the intervention group receive a virtual reality session with a hypnotic purpose during surgery under regional anesthesia. The device consists of a virtual reality headset providing visual and auditory immersion in a calming environment, freely chosen by the patient. The session begins before the regional anesthesia is administered and may continue throughout the entire surgical procedure

OTHERStandard Care (in control arm)

Participants in this group receive standard anesthetic and surgical care without the use of virtual reality


Locations(1)

Centre Hospitalier Eure-Seine

Évreux, France

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NCT07013695


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