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Completed

NCT Number: NCT07306442

VR for Pain & Sleep in Burn Patients: A RCT

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.

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Key information

Conditions

Burns Mental Disorders Nervous System Diseases Neurologic Manifestations Pain Parasomnias Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disturbances Sleep Wake Disorders Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taleghani Burn and Trauma Hospital

Ahvāz, Khuzestan, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - Adult patients aged 18 to 60 years.
  • Deep partial-thickness or full-thickness burns covering 25% to 60% of total body surface area (TBSA).
  • Hemodynamic stability (systolic BP ≥90 mmHg, HR 60-100 bpm, no vasopressor use).
  • Ability to understand and comprehend Persian language.
  • Scheduled for at least one standardized, non-sedated wound dressing change procedure.

Exclusion criteria

  • - Diagnosed psychiatric or neurological disorder (e.g., schizophrenia, epilepsy).
  • Severe visual impairment (best-corrected visual acuity <20/200) or auditory impairment.
  • History of motion sickness or VR intolerance.
  • Contraindications to VR use (e.g., active vertigo, uncontrolled hypertension).

Treatment and study plan

Virtual Reality Distraction

Behavioral

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.

Other names: VR Therapy

Standard care

Other

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.

Other names: Routine Burn Care

Primary outcomes

  1. Change in Pittsburgh Sleep Quality Index (PSQI) Total Score

    Time frame: 24 hours post-intervention

    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.

  2. Change in Visual Analog Scale (VAS) Pain Score

    Time frame: Immediately before and after the dressing change procedure

    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.

Secondary outcomes

  1. Change in individual components of the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 24 hours post-intervention

    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.

Sponsors and collaborators

Lead sponsor

Abadan University of Medical Sciences

Other

Registry information

Official study title

Abadan University of Medical Sciences

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 29, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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