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โ† Trials
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Virtual Reality for Reducing Anxiety in Pediatric Orthopedic Surgery

RecruitingNAAges 7 Years - 12 YearsAllIstituto Ortopedico Rizzoli
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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)
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What it tests

  • hypno VR
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Where

1 site
Istituto Ortopedico Rizzoli
Bologna, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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