Using virtual reality to reduce anxiety in children during orthopedic surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of virtual reality (VR) in reducing anxiety and pain in children aged 7 to 12 undergoing minor orthopedic surgeries. Participants will be randomly assigned to either a VR group, where they will use VR headsets to experience calming environments, or a standard care group receiving traditional sedative medication. The study aims to compare the outcomes of both approaches, focusing on anxiety levels, pain perception, and the need for additional medications. The research is conducted at the Istituto Ortopedico Rizzoli in Bologna, Italy.

Why it matters

Who can join: the full rules

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's running

• Istituto Ortopedico Rizzoli
  Bologna, Italy Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.