Virtual Reality for Reducing Anxiety in Pediatric Orthopedic Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

hypno VR: pre-surgery sedation using virtual reality headset

Study 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:

1. VR Group: Children will use VR headsets to immerse themselves in calming virtual environments before and during the surgery.
2. Standard Care Group: Children will receive standard sedative medication before surgery.

The study will measure:

* 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.

Eligibility

Primary outcome measure(s)

• anxiety level — 24 hours
  level of anxiety with cam-s

Trial sites (1)

More Istituto Ortopedico Rizzoli trials in Italy

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