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 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.

Nel presente studio, verranno condivisi i seguenti dati individuali dei pazienti (IPD) in forma anonimizzata e aggregata, garantendo il rispetto delle normative sulla privacy e sulla protezione dei dati personali:

1. Dati Demografici e Clinici

   • Età del partecipante (fasce di età)
   • Genere
   • Patologia cronica principale
   • Eventuali comorbidità
   • Tipo di famiglia (monogenitoriale, entrambi i genitori, altro)

2. Dati sulla Procedura e sull'Intervento

   • Tipo di procedura dolorosa eseguita (prelievo ematico, iniezione intramuscolare, medicazione)
   • Assegnazione del paziente al gruppo sperimentale (RV) o di controllo (cure standard)

3. Dati sulla Valutazione dell'Ansia e del Dolore

   • Punteggi pre-procedurali di ansia anticipatoria valutati con:
   • M-YPAS (3-6 anni)
   • CAPS (6-17 anni e genitori)
   • Punteggi post-procedurali del dolore valutati con:
   • Wong-Baker Faces Scale (3-8 anni)
   • Numerical Rating Scale (NRS) (8-17 anni)

4. Dati Statistici e di Outcome

   • Differenze nei p

01.09.2025 - 31.12.2025