Virtual Reality Adjunct for Procedural Pain and Anxiety Management in Burn Wound Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAl Hayah University In Cairo
About this trial
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
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Immersive Virtual Reality Distraction (IVRD)
BehavioralIntervention Description: Participants assigned to this intervention will receive standard analgesic care per institutional protocol in addition to an immersive virtual reality (VR) distraction intervention. During each burn dressing change, participants will wear a head-mounted display (HMD) that delivers an interactive and engaging virtual environment designed specifically to distract from procedural pain and reduce anxiety. The VR session will last for the entire duration of the dressing change (approximately 10-15 minutes) and will be administered during every session. The VR system is calibrated to provide high levels of sensory immersion to effectively divert attention from painful stimuli.
Nature Video Distraction (NVD)
BehavioralIntervention Description: Participants in this intervention will receive the same standard analgesic care provided to all subjects and, in addition, will watch a nature video on a tablet device during the burn dressing change. The video distraction serves as an active comparator to the immersive VR. The nature video is selected to be calming and engaging, and it will be played continuously during the dressing change session (approximately 10-15 minutes). This intervention allows evaluation of whether immersive VR provides additional benefit in reducing procedural pain and anxiety over a standard video distraction.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: VR DistractionExperimental treatment 1 intervention
Group B: Nature Video DistractionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Functional Status via Burn Specific Health Scale - Brief (BSHS-B)
The Burn Specific Health Scale - Brief (BSHS-B) is a validated questionnaire designed to assess physical, psychosocial, and functional outcomes in burn survivors. It evaluates domains such as physical functioning, pain, emotional health, and social reintegration. Changes in functional status over time will help determine the impact of the burn injury and the effect of the intervention on recovery.
Time frame
Assessments will be conducted at baseline (within 2 weeks post-discharge) and at follow-up visits at 3, 6, and 12 months.2
Return-to-Work Rate
This outcome measure evaluates the proportion of participants who have successfully returned to work at 12 months post-discharge. Return-to-work status will be verified by self-report and cross-referenced with available medical and employment records, serving as an indicator of long-term functional recovery and social reintegration.
Time frame
Assessed at 12 months post-discharge.Secondary outcomes
1
Quality of Life (QoL) via SF-36 Health Survey
The SF-36 Health Survey is a comprehensive, validated instrument designed to measure quality of life across eight domains, including physical functioning, bodily pain, general health perceptions, vitality, social functioning, role limitations due to physical and emotional problems, and mental health. This will provide insight into the broader impact of burn injuries and recovery over time.
Time frame
Evaluations will occur at baseline (within 2 weeks post-discharge) and at 3, 6, and 12 months follow-up.2
Range of Motion (ROM) Measurements
Range of motion (ROM) in the affected areas will be assessed using standardized goniometry. This measurement quantifies physical mobility and joint function, providing objective data on the physical recovery and potential functional limitations post-burn injury.
Time frame
Measurements will be recorded at baseline and at follow-up visits at 3, 6, and 12 months.3
Psychological Well-Being via Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) is a validated self-report questionnaire used to assess anxiety and depressive symptoms. Improving psychological well-being is a key aspect of overall recovery for burn survivors.
Time frame
HADS assessments will be administered at baseline (within 2 weeks post-discharge) and then at 3, 6, and 12 months follow-up.Sponsors and contacts
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Source ClinicalTrials.gov