Using virtual reality to enhance awake surgery experiences
Virtual Reality in Awake Surgery : Pilot Study VIRAS
This study is testing if using a virtual reality mask can help people feel more comfortable and less anxious during awake orthopedic surgeries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University Hospital, Brest Academic / other |
| Locations | 1 site (Brest) |
| Trial ID | NCT05151822 on ClinicalTrials.gov |
What this trial studies
This pilot study explores the use of a virtual reality mask to improve patient tolerance and ergonomics during orthopedic surgeries performed under local anesthesia. The study focuses on patients undergoing short, minimally invasive procedures, allowing for immersion in the operating room while the patient remains awake. The intervention includes training sessions with the virtual reality device, monitoring its effectiveness, and assessing patient anxiety levels. The goal is to evaluate how this technology can enhance the surgical experience for patients and improve overall outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 who are scheduled for orthopedic surgery under local anesthesia.
Not a fit: Patients with cognitive impairments, severe anxiety, or contraindications to surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance patient comfort and reduce anxiety during awake surgical procedures.
How similar studies have performed: While the use of virtual reality in medical settings is gaining traction, this specific application in awake surgery is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria : * Major subject * Consent for the study * Patients eligible for orthopedic surgery with local anesthetic block * Estimated duration of the Orthopedic surgery of minimum 1 hour Exclusion Criteria : * Age \< 18 years, Age \> 75 years, * Known central neurological pathology/cognitive impairment, * Mini-Mental State examination (MMSe) \< 23 if no school certificate, \< 27 if school certificate, * History of vertigo, * Claustrophobia, * Visual deficit not compatible with the use of the virtual reality mask, * Contraindication to surgery, * Outpatient treatment, * Refusal or inability to consent.
Where this trial is running
Brest
- Pr SEIZEUR Romuald — Brest, France (Recruiting)
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.