Does Virtual Reality Reduce Pain, Fear, and Behavioral Distress in Children During Burn Dressing Changes? A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Mansoura University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Pain Intensity
Study Overview
Brief Summary
Burn injuries are very painful for children, especially during dressing changes when the wound is cleaned and re-bandaged. This procedure, while necessary, can cause pain, fear, and distress that may make children afraid of future treatments. Virtual reality (VR) is a technology that uses a headset to show an immersive, interactive 3D world. It can distract children from painful medical procedures.
This study aims to find out if using VR during burn dressing changes can reduce pain, fear, and behavioral distress in children aged 6 to 12 years. Half of the children will receive standard burn care plus VR distraction during their dressing change. The other half will receive standard care only.
The study will take place at the Burns and Plastic Surgery Center, Mansoura University, Egypt. Children will be recruited from both inpatient wards and outpatient clinics. Pain will be measured using a number scale, fear using a faces scale, and distress will be observed throughout the procedure.
It is expected that children who use VR will report less pain, show less fear, and display less distress during their dressing changes compared to children who receive standard care alone.
Detailed Description
Background and Rationale
Burn injuries are among the most devastating forms of physical trauma in childhood, with profound consequences for physical health, psychological well-being, and development. Children with burn injuries experience repeated exposure to painful procedures, particularly dressing changes, which are necessary but distressing aspects of burn care. Ineffectively managed procedural distress can lead to behavioral resistance, increased pain sensitivity, anticipatory anxiety, and long-term psychological sequelae including generalized anxiety disorders, medical phobias, and post-traumatic stress disorder.
While pharmacological pain management is essential, pain is not only a sensory experience but also an emotional and cognitive one, making non-pharmacological interventions highly recommended as adjuncts. Distraction techniques are among the most frequently preferred non-pharmacological methods. Recently, virtual reality (VR) has emerged as an innovative distraction technology that provides immersive visual and auditory experiences to divert attention from painful stimuli. VR is safe, effective, and offers a high level of isolation from the medical environment, allowing children to interact with virtual worlds.
Despite growing evidence supporting VR for procedural pain management, critical gaps persist. Most pediatric VR studies focus exclusively on pain intensity, with limited examination of fear and behavioral distress as co-primary outcomes. Few randomized controlled trials have been conducted in Egyptian or Middle Eastern healthcare contexts. This trial addresses these gaps by providing a rigorous evaluation of VR's multidimensional effects within a resource-constrained healthcare setting.
Study Design
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Participants, parents, and healthcare providers administering the intervention cannot be blinded due to the nature of the VR intervention. However, outcome assessors will be blinded to group allocation. Data analysts will also remain blinded until the final analysis is complete.
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Children aged 6 to 12 years
- •Acute burn injury requiring a routine dressing change, either during inpatient hospitalization or during a scheduled outpatient clinic visit
- •Able to communicate verbally and follow simple instructions
- •Medically stable as determined by attending physician (no acute respiratory distress, hemodynamic instability, or active sepsis)
- •Written informed consent from parent/guardian
- •Verbal child assent (for children aged 7 years and older)
Exclusion Criteria
- •Burns involving the face, head, or ears that prevent safe VR headset placement
- •Cognitive, motor, visual, or hearing impairments interfering with study participation
- •History of motion sickness, seizure disorder, or migraines triggered by visual stimuli
- •Inability to maintain sitting or semi-upright position during the procedure
- •Burns greater than 60% Total Body Surface Area (TBSA) or requiring intensive care admission
Outcomes
Primary Outcomes
Pain Intensity
Time Frame: Baseline (pre-procedure) and immediately post-procedure
Pain intensity will be measured using the Numeric Rating Scale (NRS), an 11-point self-report scale ranging from 0 ("no pain") to 10 ("the worst pain imaginable"). Children will be asked to select the number that best reflects the intensity of pain they experience during the burn dressing change procedure. The NRS is recommended for use with children aged 6 years and older and has demonstrated strong psychometric properties in pediatric populations. Scores are classified as follows: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain. The primary time point for the group comparison is immediately post-procedure, with baseline scores used as a covariate in the primary analysis.
Secondary Outcomes
- Behavioral Distress(Continuously throughout the dressing change procedure at 15-second intervals)
- Pulse Rate(Baseline (pre-procedure), midway through the procedure, and immediately post-procedure)
- Respiratory Rate(Baseline (pre-procedure), midway through the procedure, and immediately post-procedure)
- Oxygen Saturation (SpO₂)(Baseline (pre-procedure), midway through the procedure, and immediately post-procedure)
- Fear Level(Baseline (pre-procedure) and immediately post-procedure)
Investigators
Ahmed Hashem El-Monshed
Assistant Professor of Psychiatric and Mental Health Nursing
Mansoura University