Actively Recruiting
Virtual Reality for Reducing Anxiety in Pediatric Orthopedic Surgery
Led by Istituto Ortopedico Rizzoli · Updated on 2026-02-18
50
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 experience less pain during minor orthopedic surgeries. The research will compare the effects of VR to the usual pre-surgery sedative medication. \*\*Study Hypotheses\*\* The researchers hypothesize that using VR will: 1\. Reduce anxiety levels in children before and after surgery compared to standard sedative medication. \*\*Who can participate?\*\* * Children aged 7 to 12 years * Undergoing minor orthopedic surgery lasting less than 60 minutes * Eligible for regional anesthesia \*\*Study Process\*\* Participants will be randomly assigned to one of two groups: 1. VR Group: Children will use VR headsets to immerse themselves in calming virtual environments before and during the surgery. 2. Standard Care Group: Children will receive standard sedative medication before surgery. The study will measure: * Levels of anxiety before and after surgery using a specific anxiety meter (CAM-S). * Stress hormone levels (cortisol, adrenaline, noradrenaline) from blood samples. * Pain levels at different times after surgery. * How well children cooperate during medical procedures. * Satisfaction levels of children, parents, and surgeons. The study is being conducted by IRCCS - Istituto Ortopedico Rizzoli in Bologna, Italy. It is a non-profit study funded by donations. The goal is to find out if VR can reduce the need for sedatives, decrease anxiety and pain, and improve the overall surgical experience for children.
CONDITIONS
Official Title
Virtual Reality for Reducing Anxiety in Pediatric Orthopedic Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 7 to 12 years
- Scheduled for minor orthopedic surgery lasting less than 60 minutes
- Eligible for regional anesthesia
- Able to understand and cooperate with study procedures
- Consent given by child and parent or legal guardian
You will not qualify if you...
- Facial trauma preventing use of VR headset
- Blindness or significant visual impairment
- Deafness or significant hearing impairment
- Cognitive impairments or intellectual disabilities
- Inability to understand the language used in VR content
- Poor fit of 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 unsafe for VR use by anesthesiologist
- Failure to properly apply topical anesthetics before invasive procedures
- Allergy to local anesthetics
- Surgery expected to last more than 60 minutes
- Anticipated need for general anesthesia or deep sedation requiring advanced airway management
- Predicted difficult venous access (DIVA)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Istituto Ortopedico Rizzoli
Bologna, Italy
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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