Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Virtual reality with hypnosis to lower anxiety and sedation during regional anesthesia for limb surgery

Official title: Evaluation of the Impact of Virtual Reality on Sedation Use in Patients Undergoing Regional Anesthesia for Scheduled Orthopedic Surgery

Run by Centre Hospitalier Eure-Seine · NCT07013695 · Data updated 2026-11-12

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.

More Sedation trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment164 (estimated)
SponsorCentre Hospitalier Eure-Seine
Academic / other
Locations1 site (Évreux)
StatusRecruiting
StartedJuly 18, 2024
Main results expectedJuly 17, 2025
Study endsJuly 19, 2025
Registry record updatedJune 10, 2025
Trial IDNCT07013695 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Centre Hospitalier Eure-Seine
    Évreux, France
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.