Virtual Reality for Reducing Anxiety in Pediatric Orthopedic Surgery

Launched by ISTITUTO ORTOPEDICO RIZZOLI · Sep 17, 2024

Keywords

ClinConnect Summary

This clinical trial, called "R.A.G.A.Z.: Virtual Reality for Reducing Anxiety and Pain in Pediatric Orthopedic Surgery," is exploring whether using virtual reality (VR) can help children feel less anxious and experience less pain during minor orthopedic surgeries. The study will compare the effects of VR to the usual sedative medication that children typically receive before surgery.

To participate in the study, children aged 7 to 12, who are scheduled for minor orthopedic surgery lasting less than 60 minutes, may qualify. During the trial, kids will be randomly placed into one of two groups: one group will wear VR headsets to relax in calming virtual environments, while the other group will receive standard sedative medication. The researchers will measure anxiety levels, stress hormone levels, pain, and overall satisfaction from the children, their parents, and the surgeons. This study aims to find out if VR can reduce the need for sedatives and improve the overall experience for children undergoing surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Children aged 7 to 12 years.
• • Scheduled for minor orthopedic surgery with a duration of less than 60 minutes.
• • Eligible for regional anesthesia.
• • Able to understand and cooperate with the study procedures.
• • Consent from both the child and their parent or legal guardian.
• Exclusion Criteria:
• • Facial trauma that prevents the use of VR headsets.
• • Blindness or significant visual impairment.
• • Deafness or significant hearing impairment.
• • Cognitive impairments or intellectual disabilities.
• • Inability to understand the language used in the VR content.
• • Poor fit of the VR headset on the child's face.
• • Inability to understand Italian.
• • Current use of analgesics or sedatives at home.
• • Certified psychiatric diagnosis.
• • Epilepsy or history of seizures.
• • Recent head trauma, severe headaches, or vertigo.
• • Any condition deemed by the anesthesiologist to be unsafe for VR use.
• • Failure to properly apply topical anesthetics before invasive procedures.
• • Allergy to local anesthetics.
• • Surgery duration expected to exceed 60 minutes.
• • Anticipated need for general anesthesia or deep sedation requiring advanced airway management.
• • Predicted difficult venous access (DIVA)