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.

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

Study Overview

• Status: Active, not recruiting
• Conditions: Pain; Anxiety; Chronic Disease
• Intervention / Treatment: Other: Virtual reality video

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Florence, Italy, 50139
    • Meyer Children's Hospital IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care
Experimental: Virtual reality video	Other: Virtual reality video; Virtual reality video: luna park, carousels, space, zoo, safari, dinosaurs, sightseeing, role-play

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage reduction in anxiety score	Effectiveness of VR in reducing pain and anxiety in children undergoing painful procedures (blood draw, intramuscular injection, and wound dressing).	From recruitment to end of painful procedure
Percentage reduction in pain		From recruitment to end of painful procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of reduction in parental anxiety	From recruitment to end of painful procedure

Collaborators and Investigators

• Sponsor: Meyer Children's Hospital IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2024
• Primary Completion (Actual): December 30, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: February 24, 2025
• First Submitted That Met QC Criteria: March 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Chronic pain; Virtual Reality; Chronic disease; Paediatric
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease Attributes; Anxiety Disorders; Chronic Disease
• Other Study ID Numbers: RV-PLS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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

• IPD Sharing Time Frame: 01.09.2025 - 31.12.2025
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No