NCT06913270 Virtual Reality Adjunct for Procedural Pain and Anxiety Management in Burn Wound Care
| NCT ID | NCT06913270 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Al Hayah University In Cairo |
| Condition | Burns |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-04-12 |
| Primary Completion | 2026-05-25 |
Trial Parameters
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Brief Summary
This randomized controlled trial is designed to evaluate the efficacy of immersive virtual reality (VR) as an adjunct to standard analgesia during dressing changes in adult burn patients. The study compares an intervention group receiving standard care combined with an immersive VR distraction (using a head-mounted display displaying an engaging virtual environment) versus a control group receiving standard care plus non-VR distraction (watching a nature video on a tablet). The primary outcomes include procedural pain intensity measured by the Visual Analog Scale (VAS) and anxiety levels measured by the State-Trait Anxiety Inventory (STAI). Secondary outcomes include patient satisfaction and physiological parameters (heart rate and blood pressure) recorded during the procedure. This trial addresses the critical gap of heterogeneity and small sample sizes noted in previous VR studies for burn care pain management (Dascal et al., 2017).
Eligibility Criteria
Inclusion Criteria: Adult burn patients (18-65 years) with confirmed partial-thickness burns. Scheduled for routine dressing changes. Able to provide informed consent. Baseline pain score of ≥4/10 during a dressing change session. Exclusion Criteria: Patients with cognitive impairment preventing comprehension of the intervention. History of severe motion sickness or visual impairments that preclude the use of VR devices. Patients with contraindications to standard analgesic care.