Recruiting NCT07013695
Evaluation of the Impact of Virtual Reality on Sedation Use in Patients Undergoing Regional Anesthesia for Scheduled Orthopedic Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual reality headset, Standard Care (in control arm).
- Who it may be relevant to
- Registry conditions: Orthopedic Procedure, Anesthesia, Sedation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device 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 - Other Standard Care (in control arm)
Participants in this group receive standard anesthetic and surgical care without the use of virtual reality
Primary outcome measures
- Comparison of sedation use rates between the experimental group and the control group (level 0 versus ≥1). [Time frame: Intraoperative period (from arrival in the operating room to the end of surgery)]
Secondary outcome measures (4)
- Mean age of patients [Time frame: Baseline (before anesthesia consultation or at inclusion)]
- Sex distribution [Time frame: Baseline (before anesthesia consultation or at inclusion)]
- type of surgery [Time frame: Baseline (before anesthesia consultation or at inclusion)]
- ASA score distribution [Time frame: Baseline (before anesthesia consultation or at inclusion)]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Centre Hospitalier Eure-Seine — Évreux
Identifiers
NCT: NCT07013695 · 2022-A00055-38