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Virtual Reality for Reducing Anxiety in Pediatric Orthopedic Surgery

NCT06604364 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-02-18

No results posted yet for this 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.

Conditions

  • Virtual Reality

Interventions

DEVICE

hypno VR

pre-surgery sedation using virtual reality headset

Sponsors & Collaborators

  • Istituto Ortopedico Rizzoli

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-03
Primary Completion
2026-06-30
Completion
2026-06-03

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06604364 on ClinicalTrials.gov