VR for Pain & Sleep in Burn Patients: A RCT

NCT07306442 | Completed

• 1 other identifier: 2004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns; Pain; Sleep Disturbances

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

  24 hours post-intervention

Study Arms (2)

Virtual Reality Intervention Group

EXPERIMENTAL

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

Standard Care Group

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: VR Therapy

Virtual Reality Intervention Group

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.

Also known as: Routine Burn Care

Standard Care Group; Virtual Reality Intervention Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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).

Sponsors & Collaborators

• Abadan University of Medical Sciences: lead

Study Sites (1)

Taleghani Burn and Trauma Hospital

Ahvāz, Khuzestan, Iran

Location

Related Publications (2)

• 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.

  PMID: 21264690 BACKGROUND

• 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.

  PMID: 2748771 BACKGROUND

MeSH Terms

Conditions

Burns; Pain; Parasomnias

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student in Health Sciences, Faculty Member, Abadan University of Medical Sciences

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

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 29, 2025
• Study Start: January 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Within 6 months after publication
• Access Criteria: Request must include a detailed research proposal and be approved by the Ethics Committee of Abadan University of Medical Sciences

Locations

IR (1)