An interventional study of Immersive Virtual Reality Distraction (IVRD) and Nature Video Distraction (NVD) in Burns, Burn Wound and Procedural Pain, sponsored by Al Hayah University In Cairo. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-06.
Sponsored by Al Hayah University In Cairo · Not applicable, Interventional, and Treatment
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).
Procedural pain during dressing changes for burn wound care remains a substantial clinical challenge affecting both patient comfort and treatment compliance. Immersive VR technology has been suggested as an effective distraction technique, potentially reducing pain and associated anxiety by providing a highly engaging alternative sensory input. However, previous studies have been limited by variable protocols and modest sample sizes.
In this single-center RCT, adult burn patients aged 18-65 years with partial-thickness burns scheduled for routine dressing changes will be enrolled. Participants will be randomly assigned in a 1:1 ratio to either:
Intervention Group: Standard care (analgesia as per institutional protocol) plus immersive VR distraction (using a commercially available head-mounted display with interactive virtual environments) Control Group: Standard care plus non-VR distraction, operationalized as watching a nature video on a tablet device.
Randomization will be computer generated.
Outcome assessors will be blinded to treatment assignment. The primary outcome measures are procedural pain intensity (assessed using a 10-cm Visual Analog Scale immediately post-procedure) and anxiety (assessed using the State-Trait Anxiety Inventory immediately post-procedure). Secondary endpoints include patient-reported satisfaction with the distraction modality and objective physiological parameters (heart rate and blood pressure) monitored throughout the procedure.
Data will be collected at each dressing change session over the study period, and repeated measures analysis will be applied to assess between-group differences.
905 studies on the registry are indexed under Burns; 164 are open to participants now.
This study's planned enrollment of 100 is above the median of 40 across 663 interventional studies indexed under Burns.
Browse Burns studies →Al Hayah University In Cairo is the lead sponsor of 14 studies on the registry; 13 are open to participants now.
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Adult burn patients (18-65 years) with confirmed partial-thickness burns. Scheduled for routine dressing changes. Able to provide . Baseline pain score of ≥4/10 during a dressing change session.
Exclusion Criteria:
Patients with cognitive impairment preventing comprehension of the intervention.
History of severe motion sickness or visual impairments that preclude the use of VR devices.
Patients with to standard analgesic care.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will receive standard analgesic care according to institutional protocols plus an immersive virtual reality (VR) distraction intervention. During each burn dressing change, participants will wear a head-mounted display delivering an interactive, engaging virtual environment specifically designed for distraction. This arm aims to assess the efficacy of VR in reducing procedural pain intensity and anxiety compared to the control condition.
Behavioral: Immersive Virtual Reality Distraction (IVRD)
Participants in this arm will receive the same standard analgesic care as the experimental group and will be provided with a non-VR distraction intervention. They will watch a nature video displayed on a tablet device during each burn dressing change session. This comparator is designed to control for the effects of distraction, allowing assessment of whether immersive VR provides additional benefit beyond conventional video distraction.
Behavioral: Nature Video Distraction (NVD)
Intervention 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.
Intervention 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.
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.
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.
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.
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.
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.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Apr 2025; primary completion for May 2026, 13 months later.
Of 210 non-industry interventional studies with no phase under Burns, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's planned 13 months is below that.
Counting every sponsor, half of 239 studies reached it within 15 months; a quarter within 6 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
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Al Hayah University In Cairo