The Effectiveness of Virtual Reality in the Management of Procedural Anxiety and Pain in Children Suffering From Chronic Pathologies or Burn Injuries.
NCT ID: NCT06862830
Last Updated: 2025-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
260 participants
INTERVENTIONAL
2024-10-22
2025-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Virtual reality video
Virtual reality video
Virtual reality video: luna park, carousels, space, zoo, safari, dinosaurs, sightseeing, role-play
Standard of care
No interventions assigned to this group
Interventions
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Virtual reality video
Virtual reality video: luna park, carousels, space, zoo, safari, dinosaurs, sightseeing, role-play
Eligibility Criteria
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Inclusion 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.
3 Years
17 Years
ALL
No
Sponsors
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Meyer Children's Hospital IRCCS
OTHER
Responsible Party
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Biagio Nicolosi
Principal Investigator
Locations
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Meyer Children's Hospital IRCCS
Florence, Italy, Italy
Countries
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Other Identifiers
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RV-PLS
Identifier Type: -
Identifier Source: org_study_id
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