Evaluation of the Impact of Virtual Reality on Sedation Use in Patients Undergoing Regional Anesthesia for Scheduled Orthopedic Surgery
NCT ID: NCT07013695
Last Updated: 2025-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
164 participants
INTERVENTIONAL
2024-07-18
2025-07-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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virtual reality group
Participants in this group receive a virtual reality session with a hypnotic objective during surgery performed under regional anesthesia. The device consists of a virtual reality headset offering immersive visual and auditory content in a calming environment chosen by the participant. The session begins before the administration of regional anesthesia and may continue throughout the surgical procedure.
Virtual 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
Control Group
Participants in this group receive standard anesthetic and surgical care without the use of virtual reality.
Standard Care (in control arm)
Participants in this group receive standard anesthetic and surgical care without the use of virtual reality
Interventions
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Virtual 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
Standard Care (in control arm)
Participants in this group receive standard anesthetic and surgical care without the use of virtual reality
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Centre Hospitalier Eure-Seine
OTHER
Responsible Party
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Principal Investigators
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Jean-Baptiste HARDY
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Eure-Seine
Locations
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Centre Hospitalier Eure-Seine
Évreux, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-A00055-38
Identifier Type: -
Identifier Source: org_study_id
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