Status:
RECRUITING
Virtual Reality for Reducing Anxiety in Pediatric Orthopedic Surgery
Lead Sponsor:
Istituto Ortopedico Rizzoli
Conditions:
Virtual Reality
Eligibility:
All Genders
7-12 years
Phase:
NA
Brief Summary
This study, titled "R.A.G.A.Z.: Virtual Reality for Reducing Anxiety and Pain in Pediatric Orthopedic Surgery," aims to see if using virtual reality (VR) can help children feel less anxious and experi...
Detailed Description
\*\*Detailed Description\*\* This study, titled "R.A.G.A.Z.: Virtual Reality for Reducing Anxiety and Pain in Pediatric Orthopedic Surgery," aims to evaluate the effectiveness of virtual reality (VR)...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 3 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06604364
Start Date
June 3 2024
End Date
June 3 2026
Last Update
February 18 2025
Active Locations (1)
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1
Istituto Ortopedico Rizzoli
Bologna, Italy