VR for Pain & Sleep in Burn Patients: A RCT

Abadan University of Medical Sciences

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.

Study Overview

• Status: Completed
• Conditions: Pain; Burns; Sleep Disturbances
• Intervention / Treatment: Behavioral: Virtual Reality Distraction; Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran
  • Khuzestan
    • Ahvāz, Khuzestan, Iran
      • Taleghani Burn and Trauma Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Intervention Group; 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; 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; Other: Standard 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.; Other Names: Routine Burn Care
Placebo Comparator: Standard Care Group; 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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Immediately before and after the dressing change procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours post-intervention

Collaborators and Investigators

• Sponsor: Abadan University of Medical Sciences

Publications and helpful links

General Publications

• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
• Hoffman HG, Chambers GT, Meyer WJ 3rd, Arceneaux LL, Russell WJ, Seibel EJ, Richards TL, Sharar SR, Patterson DR. Virtual reality as an adjunctive non-pharmacologic analgesic for acute burn pain during medical procedures. Ann Behav Med. 2011 Apr;41(2):183-91. doi: 10.1007/s12160-010-9248-7.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Actual): June 1, 2025
• Study Completion (Actual): June 1, 2025

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: December 14, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 14, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Virtual reality; Non-pharmacological intervention; Wound dressing; Tbsa
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Wounds and Injuries; Sleep Wake Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Parasomnias; Burns; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 2004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Within 6 months after publication
• IPD Sharing Access Criteria: Request must include a detailed research proposal and be approved by the Ethics Committee of Abadan University of Medical Sciences

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No