Virtual Reality Adjunct for Procedural Pain and Anxiety Management in Burn Wound Care

Official title

Efficacy of Virtual Reality as an Adjunct for Procedural Pain and Anxiety Management in Burn Wound Care: A Single-Center, Randomized Controlled Trial

Overview

This randomized controlled trial is designed to evaluate the efficacy of immersive virtual reality (VR) as an adjunct to standard analgesia during dressing changes in adult burn patients. The study compares an intervention group receiving standard care combined with an immersive VR distraction (using a head-mounted display displaying an engaging virtual environment) versus a control group receiving standard care plus non-VR distraction (watching a nature video on a tablet). The primary outcomes include procedural pain intensity measured by the Visual Analog Scale (VAS) and anxiety levels measured by the State-Trait Anxiety Inventory (STAI). Secondary outcomes include patient satisfaction and physiological parameters (heart rate and blood pressure) recorded during the procedure. This trial addresses the critical gap of heterogeneity and small sample sizes noted in previous VR studies for burn care pain management (Dascal et al., 2017).

Detailed description

Procedural pain during dressing changes for burn wound care remains a substantial clinical challenge affecting both patient comfort and treatment compliance. Immersive VR technology has been suggested as an effective distraction technique, potentially reducing pain and associated anxiety by providing a highly engaging alternative sensory input. However, previous studies have been limited by variable protocols and modest sample sizes.

In this single-center RCT, adult burn patients aged 18-65 years with partial-thickness burns scheduled for routine dressing changes will be enrolled. Participants will be randomly assigned in a 1:1 ratio to either:

Intervention Group: Standard care (analgesia as per institutional protocol) plus immersive VR distraction (using a commercially available head-mounted display with interactive virtual environments) Control Group: Standard care plus non-VR distraction, operationalized as watching a nature video on a tablet device.

Randomization will be computer generated.

Outcome assessors will be blinded to treatment assignment. The primary outcome measures are procedural pain intensity (assessed using a 10-cm Visual Analog Scale immediately post-procedure) and anxiety (assessed using the State-Trait Anxiety Inventory immediately post-procedure). Secondary endpoints include patient-reported satisfaction with the distraction modality and objective physiological parameters (heart rate and blood pressure) monitored throughout the procedure.

Data will be collected at each dressing change session over the study period, and repeated measures analysis will be applied to assess between-group differences.

Interventions

• Behavioral Immersive Virtual Reality Distraction (IVRD)
  Intervention Description: Participants assigned to this intervention will receive standard analgesic care per institutional protocol in addition to an immersive virtual reality (VR) distraction intervention. During each burn dressing change, participants will wear a head-mounted display (HMD) that delivers an interactive and engaging virtual environment designed specifically to distract from procedural pain and reduce anxiety. The VR session will last for the entire duration of the dressing cha
• Behavioral Nature Video Distraction (NVD)
  Intervention Description: Participants in this intervention will receive the same standard analgesic care provided to all subjects and, in addition, will watch a nature video on a tablet device during the burn dressing change. The video distraction serves as an active comparator to the immersive VR. The nature video is selected to be calming and engaging, and it will be played continuously during the dressing change session (approximately 10-15 minutes). This intervention allows evaluation of w

Primary outcome measures

• Functional Status via Burn Specific Health Scale - Brief (BSHS-B) [Time frame: Assessments will be conducted at baseline (within 2 weeks post-discharge) and at follow-up visits at 3, 6, and 12 months.]
• Return-to-Work Rate [Time frame: Assessed at 12 months post-discharge.]

Secondary outcome measures (3)

• Quality of Life (QoL) via SF-36 Health Survey [Time frame: Evaluations will occur at baseline (within 2 weeks post-discharge) and at 3, 6, and 12 months follow-up.]
• Range of Motion (ROM) Measurements [Time frame: Measurements will be recorded at baseline and at follow-up visits at 3, 6, and 12 months.]
• Psychological Well-Being via Hospital Anxiety and Depression Scale (HADS) [Time frame: HADS assessments will be administered at baseline (within 2 weeks post-discharge) and then at 3, 6, and 12 months follow-up.]

Eligibility criteria

Inclusion criteria

Adult burn patients (18-65 years) with confirmed partial-thickness burns. Scheduled for routine dressing changes. Able to provide informed consent. Baseline pain score of ≥4/10 during a dressing change session.

Exclusion criteria

Patients with cognitive impairment preventing comprehension of the intervention.

History of severe motion sickness or visual impairments that preclude the use of VR devices.

Patients with contraindications to standard analgesic care.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Faculty of Physical Therapy, Al Hayah University — Cairo

Identifiers

NCT: NCT06913270 · VRBURN2025-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗