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Active, Not Recruiting

NCT Number: NCT06862830

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 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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Meyer Children's Hospital IRCCS

Florence, Italy, 50139

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Eligibility Criteria: Inclusion

The study population includes children who meet the following criteria:

  • Diagnosis of a chronic condition, aged 3 to 18 years, without visual impairments or cognitive deficits, and with a confirmed diagnosis of the condition.
  • Children receiving care in the wound care nursing clinic or Medical Day Hospital (DH) who require minimally invasive painful procedures.
  • Assent and informed consent provided by both the children and their parents.
  • Children with chronic conditions that do not inherently cause chronic pain, which could alter pain perception (e.g., rheumatoid arthritis, diabetic foot, muscular dystrophy).
  • Children able to understand and communicate in Italian or English.
  • Parents able to understand and communicate in Italian or English. Eligibility Criteria: Exclusion

Children with the following characteristics will be excluded from the study:

  • Chronic condition not yet diagnosed.
  • Use of eyeglasses, presence of amblyopia or monocular vision.
  • Chronic pain, which could distort pain perception during the procedure.
  • 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).
  • Cognitive impairment preventing the proper use of assessment scales.

Treatment and study plan

Virtual reality video

Other

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

Primary outcomes

  1. Percentage reduction in anxiety score

    Time frame: 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).

  2. Percentage reduction in pain

    Time frame: From recruitment to end of painful procedure

Secondary outcomes

  1. Percentage of reduction in parental anxiety

    Time frame: From recruitment to end of painful procedure

Sponsors and collaborators

Lead sponsor

Meyer Children's Hospital IRCCS

Other

Registry information

Official study title

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.

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Mar 6, 2025
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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