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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| virtual reality group | Active Comparator | 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. |
|
| Control Group | Placebo Comparator | Participants in this group receive standard anesthetic and surgical care without the use of virtual reality. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality headset | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of sedation use rates between the experimental group and the control group (level 0 versus ≥1). | 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. | Intraoperative period (from arrival in the operating room to the end of surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean age of patients | Mean age of patient in each group at baseline | Baseline (before anesthesia consultation or at inclusion) |
| Sex distribution | Number of male and female patients in each group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lydia BEN BEKKOU | Contact | 02 32 33 86 75 | arc2.circe@ch-eureseine.fr | |
| Dihia AIDENE | Contact | 02 32 33 86 75 | arc.circe@ch-eureseine.fr |
| Name | Affiliation | Role |
|---|---|---|
| Jean-Baptiste HARDY | Centre Hospitalier Eure-Seine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Eure-Seine | Recruiting | Évreux | 27000 | France |
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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.
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| Standard Care (in control arm) | Other | Participants in this group receive standard anesthetic and surgical care without the use of virtual reality |
|
| Baseline (before anesthesia consultation or at inclusion) |
| type of surgery | Distribution of types of surgery performed in each group | Baseline (before anesthesia consultation or at inclusion) |
| ASA score distribution | Distribution of ASA physical status scores among patients in each group | Baseline (before anesthesia consultation or at inclusion) |
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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