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

Meyer Children's Hospital IRCCS

Status: Active, not recruiting

Conditions: Chronic Disease; Anxiety; Pain

Treatments: Other: Virtual reality video

Study type: Interventional

Funder types: Other

Identifiers

NCT06862830

RV-PLS

Details and patient eligibility

About

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

Enrollment: 260 patients

Sex: All

Ages: 3 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 2 patient groups

Virtual reality video

Experimental group

Treatment:

Other: Virtual reality video

Standard of care

No Intervention group