Virtual Reality for Pain and Fear in Children With Burns
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorMansoura University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual Reality (VR) Distraction
DeviceA commercially available standalone VR headset with built-in speakers and a 3D display will be used to deliver immersive, interactive, age-appropriate content. The device will be adjusted for each child's head size to ensure comfort and safety. Children will view content selected from a curated library including: interactive games (e.g., age-appropriate puzzles and engaging activities); exploration experiences (e.g., underwater worlds, space adventures); and calming environments (e.g., nature scenes, relaxing landscapes). Children will be offered a choice of 2-3 age-appropriate VR experiences based on their preferences and developmental level to maximize engagement. The VR intervention will be initiated 2-3 minutes before the dressing change begins and will continue throughout the entire procedure
Standard Burn Dressing Care
Other interventionRoutine burn dressing care provided according to standard institutional protocol at the Burns and Plastic Surgery Center, Mansoura University, Egypt. This includes: pre-procedural analgesic administration according to hospital protocol (e.g., oral or intravenous analgesics); psychological preparation by nursing staff; standard wound care procedures (wound cleansing, debridement, and dressing application); and pharmacological pain management as clinically indicated.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: VR Intervention GroupExperimental treatment 2 interventions
Group B: Standard Care Control GroupOther 1 intervention
Trial outcomes
Primary outcomes
1
Pain Intensity
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.
Time frame
Baseline (pre-procedure) and immediately post-procedureSecondary outcomes
1
Behavioral Distress
Behavioral distress will be measured using the Observational Scale of Behavioral Distress-Revised (OSBD-R). The scale assesses eight operationally defined behaviors indicating discomfort: crying, screaming, physical restraint, verbal resistance, emotional support seeking, information seeking, verbal pain expressions, and flailing. Each behavior is rated on a 4-point scale according to severity: 0 = no distress, 1 = mild distress, 2 = moderate distress, 3 = severe distress. Total scores are classified as: ≥70 = severe distress, 60-69 = moderate distress, 50-59 = mild distress. The OSBD-R has demonstrated reliability of .72 using Cronbach's alpha and interrater reliability of .89.
Time frame
Continuously throughout the dressing change procedure at 15-second intervals2
Pulse Rate
Pulse rate will be measured in beats per minute (bpm) using a pulse oximeter. This parameter provides an objective indicator of autonomic nervous system response during the burn dressing change procedure.
Time frame
Baseline (pre-procedure), midway through the procedure, and immediately post-procedure3
Respiratory Rate
Respiratory rate will be measured in breaths per minute by visual observation over a full minute. This parameter provides an objective indicator of autonomic nervous system response during the burn dressing change procedure.
Time frame
Baseline (pre-procedure), midway through the procedure, and immediately post-procedure4
Oxygen Saturation (SpO₂)
Oxygen saturation (SpO₂) will be measured as a percentage (%) using a pulse oximeter. This parameter provides an objective indicator of physiological stability during the burn dressing change procedure.
Time frame
Baseline (pre-procedure), midway through the procedure, and immediately post-procedureSponsors and contacts
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Source ClinicalTrials.gov
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