Virtual Reality for Reducing Anxiety in Pediatric Orthopedic Surgery

NCT06604364 | Recruiting

• 1 other identifier: 211/2024/DISP/IOR
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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. \*\*Study Hypotheses\*\* The researchers hypothesize that using VR will: 1\. Reduce anxiety levels in children before and after surgery compared to standard sedative medication. \*\*Who can participate?\*\*

• Children aged 7 to 12 years
• Undergoing minor orthopedic surgery lasting less than 60 minutes
• Eligible for regional anesthesia \*\*Study Process\*\* Participants will be randomly assigned to one of two groups:
• VR Group: Children will use VR headsets to immerse themselves in calming virtual environments before and during the surgery.
• Standard Care Group: Children will receive standard sedative medication before surgery.
• Levels of anxiety before and after surgery using a specific anxiety meter (CAM-S).
• Stress hormone levels (cortisol, adrenaline, noradrenaline) from blood samples.
• Pain levels at different times after surgery.
• How well children cooperate during medical procedures.
• Satisfaction levels of children, parents, and surgeons. The study is being conducted by IRCCS - Istituto Ortopedico Rizzoli in Bologna, Italy. It is a non-profit study funded by donations. The goal is to find out if VR can reduce the need for sedatives, decrease anxiety and pain, and improve the overall surgical experience for children.

Conditions

Virtual Reality

Outcome Measures

Primary Outcomes (1)

• anxiety level

  level of anxiety with cam-s

  24 hours

Secondary Outcomes (8)

• hormons levels

  preoperative

• pain level

  24 hours

• compliance during induction

  during induction

• drugs dosage

  intraoperative

• surgeons satisfaction

  immediately after the intervention

Study Arms (2)

control

NO INTERVENTION

pre-surgery sedation

VR

EXPERIMENTAL

virtual reality sedation

Device: hypno VR

Interventions

hypno VR DEVICE

pre-surgery sedation using virtual reality headset

VR

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify 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 may not qualify 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.
• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, Italy

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: June 3, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 3, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

IT (1)