BridgeMD
New treatment option for Virtual Reality
Official title Virtual Reality for Reducing Anxiety in Pediatric Orthopedic Surgery
ClinicalTrials.gov ID: NCT06604364
What this study is testing
- What it's testing
- 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.
- Time commitment: about 24 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 to 12. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Bologna, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 7 years to 12 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bologna, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.