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

The Effectiveness of Virtual Reality in the Management of Procedural Anxiety and Pain in Children Suffering From Chronic Pathologies or Burn Injuries. Single-center Randomized Controlled Trial.

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06862830
Enrollment
260
Registered
2025-03-06
Start date
2024-10-22
Completion date
2025-04-30
Last updated
2025-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Chronic Disease, Pain

Keywords

Virtual Reality, Chronic pain, Paediatric, Chronic disease

Brief 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

Interventions

OTHERVirtual reality video

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

Sponsors

Meyer Children's Hospital IRCCS
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Percentage reduction in anxiety scoreFrom recruitment to end of painful procedureEffectiveness of VR in reducing pain and anxiety in children undergoing painful procedures (blood draw, intramuscular injection, and wound dressing).
Percentage reduction in painFrom recruitment to end of painful procedure

Secondary

MeasureTime frame
Percentage of reduction in parental anxietyFrom recruitment to end of painful procedure

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026