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

NCT06862830 | Active Not Recruiting

• 1 other identifier: RV-PLS
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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

Conditions

Anxiety; Chronic Disease; Pain

Keywords

Virtual Reality; Chronic pain; Paediatric; Chronic disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Percentage of reduction in parental anxiety

  From recruitment to end of painful procedure

Study Arms (2)

Virtual reality video

EXPERIMENTAL

Other: Virtual reality video

Standard of care

NO INTERVENTION

Interventions

Virtual reality video OTHER

Virtual reality video: luna park, carousels, space, zoo, safari, dinosaurs, sightseeing, role-play

Virtual reality video

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Meyer Children's Hospital IRCCS: lead

Study Sites (1)

Meyer Children's Hospital IRCCS

Florence, Italy, 50139, Italy

Location

MeSH Terms

Conditions

Anxiety Disorders; Chronic Disease; Pain; Chronic Pain

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 6, 2025
• Study Start: October 22, 2024
• Primary Completion: December 30, 2024
• Study Completion: April 1, 2025
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 01.09.2025 - 31.12.2025

Locations

IT (1)