Skip to content

VR for Pain & Sleep in Burn Patients: A RCT

Abadan University of Medical Sciences

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07306442
Enrollment
60
Registered
2025-12-29
Start date
2025-01-01
Completion date
2025-06-01
Last updated
2025-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns, Pain, Sleep Disturbances

Keywords

Virtual reality, Non-pharmacological intervention, Wound dressing, Tbsa

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALVirtual Reality Distraction

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.

OTHERStandard Care

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.

Sponsors

Abadan University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Masking description

Blinding was not feasible due to the visible nature of the VR headset and the need for participants and care providers to be aware of group assignment during the intervention. However, data collection and analysis were performed by blinded personnel.

Intervention model description

This is a two-arm, parallel-group, randomized controlled trial comparing virtual reality intervention with standard care in burn patients.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Change in Pittsburgh Sleep Quality Index (PSQI) Total Score24 hours post-interventionThe 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.
Change in Visual Analog Scale (VAS) Pain ScoreImmediately before and after the dressing change procedureThe 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

MeasureTime frameDescription
Change in individual components of the Pittsburgh Sleep Quality Index (PSQI)24 hours post-interventionSecondary 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.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026