What this Trial Is About

Researchers are investigating whether using Virtual Reality (VR) glasses can be a helpful alternative to usual relaxing or pain-relieving medications for reducing anxiety during surgery under local anesthesia. This study focuses on elderly patients aged 65 and older who are scheduled for surgeries lasting up to 90 minutes and receiving local anesthesia with sedation. It is a Phase 4 randomized controlled trial comparing standard sedation alone to sedation combined with VR distraction. Participants are randomly assigned to either receive standard sedation or sedation while using VR glasses featuring specially designed software films to provide distraction during awake surgery. The surgeries take place at multiple hospitals and include procedures such as open inguinal hernia surgery, vascular interventions, and surgeries on the hand, arm, lower extremity, and urology, all under infiltration or block anesthesia. The VR is used during the surgery period with monitoring of sedative medication doses, anxiety levels, and patient and surgeon experience. During the study, patients will have their anxiety and pain assessed before, during, and after surgery using validated scales like the State-Trait Anxiety Inventory and numerical rating scales. Researchers will also measure physiological markers of stress, sedative medication doses (particularly propofol mg/kg during surgery), recovery milestones such as time to urination and discharge, and patient well-being for five days postoperatively. Two weeks after surgery, patients will be interviewed via Zoom to discuss their experience. The main outcomes focus on sedative medication use and anxiety-related stress during surgery.

Virtual Reality (VR) Could Be a Good Alternative to Relaxing or Pain-relieving Medication