Actively Recruiting
Efficacy of Virtual Reality as an Adjunct for Procedural Pain and Anxiety Management in Burn Wound Care: A Single-Center, Randomized Controlled Trial
Led by Al Hayah University In Cairo · Updated on 2025-04-06
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of immersive virtual reality (VR) as an addition to standard pain relief methods during dressing changes for adult burn patients. This randomized controlled trial compares an intervention group receiving standard care plus immersive VR distraction using a head-mounted display with a control group receiving standard care plus non-VR distraction by watching a nature video on a tablet. The study aims to measure procedural pain intensity and anxiety levels to address the variability and small sample sizes of previous VR studies in burn care pain management. Participants aged 18 to 65 with partial-thickness burns scheduled for routine dressing changes will be randomly assigned to one of two groups. The intervention group will wear a VR headset during each dressing change session, lasting about 10 to 15 minutes, to experience an engaging virtual environment designed to distract from pain and anxiety. The control group will watch a calming nature video on a tablet during their dressing changes. Both groups will receive standard analgesic care following institutional protocols. During the study, data on pain intensity using a Visual Analog Scale and anxiety using the State-Trait Anxiety Inventory will be collected immediately after each dressing change. Additional measures include patient satisfaction and physiological parameters such as heart rate and blood pressure recorded throughout the procedure. Outcome assessors will be blinded to group assignments. The trial will collect repeated measures over dressing change sessions to compare effects between groups.
CONDITIONS
Brief Title
Virtual Reality Adjunct for Procedural Pain and Anxiety Management in Burn Wound Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult burn patients aged 18 to 65 years
- Confirmed partial-thickness burns
- Scheduled for routine dressing changes
- Able to provide informed consent
- Baseline pain score of 4 or higher during a dressing change session
You will not qualify if you...
- Cognitive impairment preventing understanding of the intervention
- History of severe motion sickness
- Visual impairments that prevent use of VR devices
- Contraindications to standard analgesic care
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated dressing change sessions over the study period
Participants receive standard analgesic care during routine burn dressing changes. They will also receive either immersive virtual reality distraction or watch a nature video to help manage procedural pain and anxiety during each dressing change session.
Visits at each dressing change session (approximately 10-15 minutes per session)
Duration - Up to 12 months post-discharge
Participants will be assessed for functional status, quality of life, range of motion, and psychological well-being after discharge at multiple time points.
Follow-up visits at baseline (within 2 weeks post-discharge), and at 3, 6, and 12 months
Trial Site Locations
Total: 1 location
1
Faculty of Physical Therapy, Al Hayah University
Cairo, Egypt, 12111
Actively Recruiting
Research Team
I
Ibrahim Zoheiry, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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