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Clinical Trials in Italy / NCT06862830
Active, not recruiting Not applicable

The Effectiveness of Virtual Reality in the Management of Procedural Anxiety and Pain in Children Suffering From Chronic Pathologies or Burn Injuries.

NCT06862830 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2024-10-22
Last updated
2025-03-06

Condition(s) studied

AnxietyChronic DiseasePain

Investigational drug(s) / intervention(s)

Virtual reality video

Virtual reality video: Virtual reality video: luna park, carousels, space, zoo, safari, dinosaurs, sightseeing, role-play

Study summary

Single-center, randomized, controlled clinical trial (RCT) to evaluate the efficacy of VR on pain and anxiety in children with chronic diseases undergoing painful procedures in an outpatient or day hospital setting

Eligibility

Sex
ALL
Min age
3 Years
Max age
17 Years
Healthy volunteers
No
Eligibility Criteria: Inclusion The study population includes children who meet the following criteria: 1. Diagnosis of a chronic condition, aged 3 to 18 years, without visual impairments or cognitive deficits, and with a confirmed diagnosis of the condition. 2. Children receiving care in the wound care nursing clinic or Medical Day Hospital (DH) who require minimally invasive painful procedures. 3. Assent and informed consent provided by both the children and their parents. 4. Children with chronic conditions that do not inherently cause chronic pain, which could alter pain perception (e.g., rheumatoid arthritis, diabetic foot, muscular dystrophy). 5. Children able to understand and communicate in Italian or English. 6. Parents able to understand and communicate in Italian or English. Eligibility Criteria: Exclusion Children with the following characteristics will be excluded from the study: 1. Chronic condition not yet diagnosed. 2. Use of eyeglasses, presence of amblyopia or monocular vision. 3. Chronic pain, which could distort pain perception during the procedure. 4. Use of analgesic therapy within the last 8 hours, which could bias data collection results (the only prohibited therapy in the study and a reason for exclusion). 5. Cognitive impairment preventing the proper use of assessment scales.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Meyer Children's Hospital IRCCS Florence Italy

More Meyer Children's Hospital IRCCS trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06862830 on ClinicalTrials.gov ↗ ← All trials in Italy