Virtual Reality for Reducing Anxiety in Pediatric Orthopedic Surgery
Recruiting · NCT06604364 · Interventional (participants receive a specific treatment) · Lead sponsor: Istituto Ortopedico Rizzoli
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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)
Where it is running
1 location listed.
- Istituto Ortopedico Rizzoli - Bologna, Italy