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Virtual Reality for Reducing Anxiety in Pediatric Orthopedic Surgery

Study acronym: RAGAZ
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 18, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Re-verified, no change to tracked fieldsv4
  2. Notable Primary completion date: Jan 2025 to Jun 2026
    • Site contact updated
    v3
  3. Minor Primary completion date: Jan 3, 2025 to Jan 2025
    • Site contact updated
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06604364
Lead Sponsor Istituto Ortopedico Rizzoli
Conditions
(from sponsor)
Virtual Reality
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov