An interventional study of Virtual Reality Distraction and Standard Care in Burns, Pain and Sleep Disturbances, sponsored by Abadan University of Medical Sciences. Completed at 1 site in Iran. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-12-29.
Sponsored by Abadan University of Medical Sciences · Not applicable, Interventional, and Supportive care
This study aims to evaluate whether virtual reality (VR) can reduce pain and improve sleep quality during wound dressing changes in burn patients with 25-60% total body surface area (TBSA) burns, compared to standard care.
Background:
Burn injuries are extremely painful, especially during wound dressing changes. They also cause severe sleep problems, which can slow down healing. While medicines help, they often have side effects and don't fully solve these issues. Virtual reality (VR) is a new tool that distracts the brain from pain by immersing patients in a calming digital world. This study was designed to assess if VR could help with both pain and sleep in burn patients.
Methods:
We conducted a randomized controlled trial with 60 adult burn patients who had between 25% and 60% of their body burned. All patients were stable and able to understand instructions. We randomly assigned them into two groups: one group used VR headsets during their dressing changes, and the other group received standard care without VR. Pain was measured before and after the procedure using a simple 0-to-10 scale. Sleep quality was assessed using a standard questionnaire (PSQI) before and 24 hours after the treatment.
719 studies on the registry are indexed under Burns; 145 are open to participants now.
This study's enrollment of 60 is above the median of 40 across 524 interventional studies indexed under Burns.
Browse Burns studies →This is the only study on the registry with Abadan University of Medical Sciences as lead sponsor.
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Exclusion Criteria:
Participants in this group received immersive virtual reality distraction during their wound dressing change procedure. They wore an Oculus Quest 2 headset and were immersed in a calming, interactive virtual environment (e.g., a peaceful beach or forest) for the duration of the dressing change (approximately 30-45 minutes). The audio was enabled to enhance immersion.
Behavioral: Virtual Reality Distraction · Other: Standard Care
Participants in this group received standard care during their wound dressing change, which included verbal reassurance and routine analgesic administration as prescribed, without any additional distraction techniques such as virtual reality.
Other: Standard Care
Participants in the experimental group received immersive virtual reality distraction during their wound dressing change procedure. They wore an Oculus Quest 2 headset and were immersed in a calming, interactive virtual environment (e.g., a peaceful beach or forest) for the duration of the dressing change (approximately 30-45 minutes). The audio was enabled to enhance immersion. This intervention aimed to reduce procedural pain and improve sleep quality through cognitive distraction and relaxation.
Also known as: VR Therapy
Participants in the control group received standard care during their wound dressing change, which included verbal reassurance and routine analgesic administration as prescribed, without any additional distraction techniques such as virtual reality. No specific intervention was administered beyond standard clinical practice.
Also known as: Routine Burn Care
Change in Pittsburgh Sleep Quality Index (PSQI) Total Score
The primary outcome for sleep quality was the change in the total score of the Pittsburgh Sleep Quality Index (PSQI) from baseline to 24 hours post-intervention. The PSQI is a validated self-report questionnaire assessing seven components of sleep quality over the past month. A higher score indicates poorer sleep quality. The change score (post-intervention minus pre-intervention) was calculated, with negative values indicating improvement.
Time frame: 24 hours post-intervention
Change in Visual Analog Scale (VAS) Pain Score
The primary outcome for pain was the change in the Visual Analog Scale (VAS) score from immediately before to immediately after the wound dressing change procedure. The VAS is a 10-cm scale where 0 represents "no pain" and 10 represents "worst pain imaginable." The change score (post-procedure minus pre-procedure) was calculated, with negative values indicating pain reduction.
Time frame: Immediately before and after the dressing change procedure
Change in individual components of the Pittsburgh Sleep Quality Index (PSQI)
Secondary outcomes included changes in each of the seven individual components of the PSQI: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. These were assessed at baseline and 24 hours post-intervention.
Time frame: 24 hours post-intervention
Plan to share: Yes — Yes, but only for specific purposes or under certain conditions Individual participant data (IPD) will be made available upon reasonable request to the corresponding author. Data sharing is subject to approval by the Ethics Committee of Abadan University of Medical Sciences and may require a formal data use agreement. Requests should include a detailed research proposal and must comply with local ethical and legal regulations.
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