Anxiety, Chronic Disease, Pain
Conditions
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
Virtual reality video: luna park, carousels, space, zoo, safari, dinosaurs, sightseeing, role-play
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Percentage reduction in anxiety score | From recruitment to end of painful procedure | Effectiveness of VR in reducing pain and anxiety in children undergoing painful procedures (blood draw, intramuscular injection, and wound dressing). |
| Percentage reduction in pain | From recruitment to end of painful procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of reduction in parental anxiety | From recruitment to end of painful procedure |
Countries
Italy