Virtual reality with hypnosis to lower anxiety and sedation during regional anesthesia for limb surgery
Evaluation of the Impact of Virtual Reality on Sedation Use in Patients Undergoing Regional Anesthesia for Scheduled Orthopedic Surgery
The team will try virtual reality combined with hypnosis to reduce anxiety and the need for sedatives in adults having scheduled upper or lower limb orthopedic surgery under regional anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Eure-Seine Academic / other |
| Locations | 1 site (Évreux) |
| Trial ID | NCT07013695 on ClinicalTrials.gov |
What this trial studies
This randomized interventional study assigns adults undergoing scheduled regional anesthesia for upper or lower limb orthopedic surgery to either a virtual reality headset with hypnosis or to standard care without the device. Researchers will compare anxiety and satisfaction using questionnaires and will record sedative use during the procedure. Key exclusions include psychiatric or cognitive disorders, premedication before arrival, language barriers, and emergency surgeries. The trial is conducted at a single center, Centre Hospitalier Eure-Seine in Évreux, France.
Who should consider this trial
Good fit: Adults aged 18 or older who are scheduled for regional anesthesia for elective upper or lower limb orthopedic surgery, can give informed consent, and meet local social security affiliation requirements are ideal candidates.
Not a fit: Patients undergoing emergency surgery, those requiring general anesthesia, or patients with psychiatric, cognitive, or communication disorders (or where the device would interfere with the procedure) are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could reduce perioperative anxiety and decrease the amount of sedative medication patients need, improving comfort and lowering drug-related side effects.
How similar studies have performed: Prior small trials and procedural studies have shown that virtual reality can reduce anxiety and pain in perioperative and procedural settings, but combining VR with hypnosis in regional anesthesia for orthopedic surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Évreux
- Centre Hospitalier Eure-Seine — Évreux, France (Recruiting)
Study contacts
- Principal investigator: Jean-Baptiste HARDY — Centre Hospitalier Eure-Seine
- Study coordinator: Lydia BEN BEKKOU
- Email: arc2.circe@ch-eureseine.fr
- Phone: 02 32 33 86 75
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.