Anesthesia, Orthopedic Procedure, Sedation
Conditions
Brief 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.
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
Sponsors
Centre Hospitalier Eure-Seine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Randomized parallel-group study with two arms (virtual reality group vs. control group) comparing the effect of virtual reality on sedation use during regional anesthesia.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of sedation use rates between the experimental group and the control group (level 0 versus ≥1). | Intraoperative period (from arrival in the operating room to the end of surgery) | Proportion of patients who required sedation (at level ≥1) during regional anesthesia or surgery, compared to those who did not receive sedation (level 0). Sedation levels are defined according to a standardized scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean age of patients | Baseline (before anesthesia consultation or at inclusion) | Mean age of patient in each group at baseline |
| Sex distribution | Baseline (before anesthesia consultation or at inclusion) | Number of male and female patients in each group |
| type of surgery | Baseline (before anesthesia consultation or at inclusion) | Distribution of types of surgery performed in each group |
| ASA score distribution | Baseline (before anesthesia consultation or at inclusion) | Distribution of ASA physical status scores among patients in each group |
Countries
France
Contacts
Primary ContactLydia BEN BEKKOU
Backup ContactDihia AIDENE
Outcome results
None listed