Using virtual reality to reduce anxiety in children during orthopedic surgery
realtà Aumentata Generatrice di Ansia Zero
This study is testing if using virtual reality can help reduce anxiety and pain in children aged 7 to 12 during minor orthopedic surgeries compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 7 Years to 12 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06604364 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 7 to 12 years scheduled for minor orthopedic surgery lasting less than 60 minutes.
Not a fit: Patients with conditions that prevent the use of VR headsets, such as facial trauma or significant sensory impairments, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce anxiety and pain for pediatric patients undergoing surgery, leading to better overall experiences and outcomes.
How similar studies have performed: Other studies have shown promising results using VR for anxiety reduction in various medical settings, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bologna
- Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.