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VR headsets replace sedatives for kids in surgery trial

NCT ID NCT06604364

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

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

7 to 12 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

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How to take part

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  2. The official record

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Contacts and locations

Locations

  • Istituto Ortopedico Rizzoli

    RECRUITING

    Bologna, Italy

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