VR headsets replace sedatives for kids in surgery trial
NCT ID NCT06604364
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether virtual reality (VR) can reduce anxiety and pain in children aged 7 to 12 during minor orthopedic surgery. Half the children will use a VR headset with calming scenes before and during surgery, while the other half receive standard sedative medication. Researchers will measure anxiety, stress hormones, pain, and satisfaction to see if VR can improve the surgical experience.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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7 to 12 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Istituto Ortopedico Rizzoli
RECRUITINGBologna, Italy
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