Virtual Reality for Pain and Fear in Children With Burns

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

This is a randomized controlled trial (RCT) with two parallel groups and a 1:1 allocation ratio. The trial will be designed, conducted, and reported in accordance with the CONSORT (Consolidated Standards of Reporting Trials) statement. The trial will be prospectively registered on ClinicalTrials.gov prior to enrollment of the first participant.

Setting

The study will be conducted at the Burns and Plastic Surgery Center, Mansoura University, Egypt, across both inpatient burn units and outpatient burn dressing clinics.

Participants

A total of 80 children aged 6 to 12 years with acute burn injuries requiring routine dressing changes will be enrolled. Inclusion criteria include: ability to communicate verbally and follow simple instructions; medically stable as determined by the attending physician; written informed consent from parent/guardian; and verbal child assent for children aged 7 years and older. Exclusion criteria include: burns involving the face, head, or ears preventing safe VR headset placement; cognitive, motor, visual, or hearing impairments; history of motion sickness, seizure disorder, or migraines triggered by visual stimuli; inability to maintain a sitting/semi-upright position; burns greater than 60% Total Body Surface Area (TBSA); or requiring intensive care admission.

Intervention

Children assigned to the study group will receive VR distraction in addition to routine burn dressing care. The VR intervention will be initiated 2-3 minutes before the dressing change begins and will continue throughout the entire procedure. The intervention will be delivered using a commercially available standalone VR headset with built-in speakers and a 3D display, adjusted for each child's head size. Children will view age-appropriate, interactive 3D content selected from a curated library, including interactive games, exploration experiences (e.g., underwater worlds, space adventures), and calming environments (e.g., nature scenes). Children will be offered a choice of 2-3 age-appropriate VR experiences based on their preferences. The VR session may be briefly paused if the child requests a break or if any adverse effects (nausea, dizziness, headache, or device discomfort) are reported.

Children assigned to the control group will receive routine burn dressing care according to standard institutional protocol, which includes pre-procedural analgesic administration, psychological preparation by nursing staff, standard wound care procedures, and pharmacological pain management as clinically indicated. No structured distraction or non-pharmacological interventions beyond standard nursing care will be provided to the control group.

Outcome Measures

The primary outcome is pain intensity, measured immediately post-procedure using the Numeric Rating Scale (NRS), an 11-point scale ranging from 0 ("no pain") to 10 ("the worst pain imaginable").

Secondary outcomes include:

Fear, measured pre- and post-procedure using the Children's Fear Scale (CFS), a 5-point faces scale ranging from 0 ("no fear") to 4 ("extreme fear").

Behavioral distress, measured continuously throughout the procedure at 15-second intervals using the Observational Scale of Behavioral Distress-Revised (OSBD-R), which assesses eight behaviors: crying, screaming, physical restraint, verbal resistance, emotional support seeking, information seeking, verbal pain expressions, and flailing.

Physiological parameters (pulse rate, respiratory rate, and oxygen saturation), measured pre- and post-procedure.

Data Collection Procedures

The study will be conducted in three phases:

Preparation Phase: Ethical approval will be obtained from the Research Ethics Committee of the Faculty of Nursing, Mansoura University. All tools will be translated into Arabic using forward-backward translation methods and reviewed by experts. A pilot study will be conducted on 10% of the target sample to evaluate tool clarity and applicability.

Implementation Phase: Eligible children will be recruited from inpatient burn wards and outpatient clinics. After obtaining informed consent, participants will be randomly assigned to the study or control group using a computer-generated randomization sequence with variable block sizes of 4 and 6. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes opened only after baseline assessment is complete. Baseline assessments (pain, fear, physiological parameters) will be conducted before the procedure. The intervention group will receive VR 2-3 minutes before the dressing change. The control group will receive standard care only. Outcome measures will be reassessed immediately post-procedure.

Evaluation Phase: Data will be analyzed to determine the effect of VR on children's pain, fear, and behavioral distress during burn dressing changes.

Blinding

Due to the nature of the intervention, participants, parents, and healthcare providers administering the intervention cannot be blinded to group allocation. However, outcome assessors will be blinded to group assignment. Data analysts will also remain blinded until the final analysis is completed.

Sample Size

Sample size was calculated a priori using G\*Power (version 3.1.9.7) for an independent-samples t-test comparing post-procedure pain intensity between groups. With an alpha level of 0.05 (two-tailed), power of 80%, and an allocation ratio of 1:1, the minimum required sample size was 32 children per group (64 total). To account for anticipated attrition of approximately 20%, the final target sample size was set at 40 children per group (80 total).

Statistical Analysis

Data will be analyzed using IBM SPSS Statistics (version 30). An alpha level of 0.05 (two-tailed) will be used to determine statistical significance. Descriptive statistics will summarize participant characteristics and baseline variables. Baseline comparability between groups will be tested using independent-samples t-test (or Mann-Whitney U test) for continuous variables and Chi-square test (or Fisher's exact test) for categorical variables. Primary and secondary outcomes will be compared between groups at each time point using independent-samples t-test or Mann-Whitney U test. A two-way mixed-design ANOVA or generalized estimating equations (GEE) model will be used to examine group × time interaction effects, with post-hoc pairwise comparisons where the interaction is significant.

Ethical Considerations

The study will be conducted in accordance with the ethical principles of the Declaration of Helsinki. Written informed consent will be obtained from each participant (children and their accompanying caregiver) after explanations of the aim and benefits of the study. Anonymity and confidentiality will be guaranteed, and participants have the right to withdraw at any time without reason or penalty.

Trial Registration

The trial will be prospectively registered on ClinicalTrials.gov prior to the enrollment of the first participant.

• Behavioral Distress [Срок оценки: Continuously throughout the dressing change procedure at 15-second intervals]
• Pulse Rate [Срок оценки: Baseline (pre-procedure), midway through the procedure, and immediately post-procedure]
• Respiratory Rate [Срок оценки: Baseline (pre-procedure), midway through the procedure, and immediately post-procedure]
• Oxygen Saturation (SpO₂) [Срок оценки: Baseline (pre-procedure), midway through the procedure, and immediately post-procedure]
• Fear Level [Срок оценки: Baseline (pre-procedure) and immediately post-procedure]