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

Not Applicable

Active, not recruiting

• Conditions: Anxiety; Chronic Disease; Pain

• Registration Number: NCT06862830
• Lead Sponsor: Meyer Children's Hospital IRCCS

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-22
• Primary Completion: 2024-12-30
• Study First Submitted: 2025-02-24
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-03
• Last Update Submitted: 2025-03-03
• Study First Posted: 2025-03-06
• Last Update Posted: 2025-03-06
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Percentage of reduction in parental anxiety	From recruitment to end of painful procedure

Trial Locations

Locations (1)

Meyer Children's Hospital IRCCS; 🇮🇹 Florence, Italy