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Completed
NCT07729020
Effectiveness of Virtual Reality in Reducing Anxiety and Pain During the First Postoperative Orthopedic Dressing Change in Pediatric Patients
Conditions: Anxiety, Pain, Post Operative
Sex: All
Ages: 6 Years – 18 Years
Healthy volunteers: No
Phase: NA
Enrollment: 48
Sponsor: Gianluca Catania
Location: Dipartimento di scienze della salute, DISSAL - UNIGE Genoa Liguria
Summary
The goal of this randomized clinical trial is to learn whether immersive virtual reality can reduce anxiety and pain in children and adolescents undergoing postoperative orthopedic dressing changes. The main questions it aims to answer are:
Does immersive virtual reality reduce anxiety during postoperative dressing changes compared with standard care?
Does immersive virtual reality reduce pain and physiological signs of distress, such as changes in heart rate and respiratory rate?
Researchers will compare participants who use an immersive virtual reality headset during the dressing change with participants who receive standard care without virtual reality.
Participants will:
Be randomly assigned to the virtual reality group or the standard care group
Undergo a postoperative orthopedic dressing change with or without immersive virtual reality
Report their anxiety and pain before and after the procedure
Have their heart rate and respiratory rate measured before, during, and after the dressing change
Eligibility Criteria
Inclusion Criteria
* Patients aged 6-18 years.
* Undergoing corrective orthopedic surgery for congenital or acquired limb deformities, with or without external fixation devices, or spinal arthrodesis for scoliosis or spondylolisthesis.
* Undergoing the first postoperative wound dressing procedure.
* Written informed consent obtained from a parent or legal guardian.
* Assent obtained from the participant, when appropriate. Exclusion Criteria
* Neurological disorders.
* History of epilepsy.
* Prematurity.
* Sensory impairments preventing the use of the virtual reality headset.
* Cognitive impairments preventing the use of the virtual reality headset.
* Motor limitations preventing the use of the virtual reality headset.
Source: ClinicalTrials.gov (NCT07729020). StuddyBuddy aggregates publicly available trial information.