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Completed
NCT07335666
Virtual Reality Versus Game Card Distraction During Pediatric Wound Care
Conditions: Pediatric Wounds, Procedural Pain, Procedure-Related Anxiety, Procedural Fear
Sex: All
Ages: 5 Years – 10 Years
Healthy volunteers: No
Phase: NA
Enrollment: 90
Sponsor: Agri Ibrahim Cecen University
Location: Ağrı Training and Research Hospital Center AĞRI
Summary
This completed randomized study compared two distraction approaches with standard care during pediatric open wound care. Ninety children aged 5-10 years were assigned to standard care alone, standard care plus distraction game cards, or standard care plus immersive audiovisual virtual reality. Fear, state anxiety, pain, heart rate, and peripheral oxygen saturation were assessed immediately before and shortly after wound care. The purpose was to compare psychological and physiological responses among the three groups and to assess whether virtual reality provided additional benefit compared with game cards.
Eligibility Criteria
Inclusion Criteria:
* Aged 5-10 years
* Presented with an open wound requiring cleansing, dressing, debridement, and/or suturing
* Hemodynamically stable at baseline, with peripheral oxygen saturation of at least 95 percentage and heart rate within age-appropriate limits
* Able to communicate sufficiently to complete the study assessments
* Written informed consent provided by a parent or legal guardian
* Verbal assent provided by the child
Exclusion Criteria:
* Neurodevelopmental or communication disorder that could interfere with study assessments
* Significant visual or hearing impairment
* Head or facial wound preventing use of the virtual reality headset
* History of motion sickness or a previous adverse reaction to virtual reality
* Receipt of sedatives or systemic opioid analgesics within 6 hours before the procedure
* Requirement for procedural sedation during wound care
* Any clinical condition judged by the attending physician to make participation inappropriate
Source: ClinicalTrials.gov (NCT07335666). StuddyBuddy aggregates publicly available trial information.