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

NCT06913270 | Recruiting

• 1 other identifier: VRBURN2025-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Burns; Burn Wound; Procedural Pain; Anxiety Acute

Outcome Measures

Primary Outcomes (2)

• Functional Status via Burn Specific Health Scale - Brief (BSHS-B)

  The Burn Specific Health Scale - Brief (BSHS-B) is a validated questionnaire designed to assess physical, psychosocial, and functional outcomes in burn survivors. It evaluates domains such as physical functioning, pain, emotional health, and social reintegration. Changes in functional status over time will help determine the impact of the burn injury and the effect of the intervention on recovery.

  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

  This outcome measure evaluates the proportion of participants who have successfully returned to work at 12 months post-discharge. Return-to-work status will be verified by self-report and cross-referenced with available medical and employment records, serving as an indicator of long-term functional recovery and social reintegration.

  Assessed at 12 months post-discharge.

Secondary Outcomes (3)

• Quality of Life (QoL) via SF-36 Health Survey

  Evaluations will occur at baseline (within 2 weeks post-discharge) and at 3, 6, and 12 months follow-up.

• Range of Motion (ROM) Measurements

  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)

  HADS assessments will be administered at baseline (within 2 weeks post-discharge) and then at 3, 6, and 12 months follow-up.

Study Arms (2)

VR Distraction

EXPERIMENTAL

Participants in this arm will receive standard analgesic care according to institutional protocols plus an immersive virtual reality (VR) distraction intervention. During each burn dressing change, participants will wear a head-mounted display delivering an interactive, engaging virtual environment specifically designed for distraction. This arm aims to assess the efficacy of VR in reducing procedural pain intensity and anxiety compared to the control condition.

Behavioral: Immersive Virtual Reality Distraction (IVRD)

Nature Video Distraction

ACTIVE COMPARATOR

Participants in this arm will receive the same standard analgesic care as the experimental group and will be provided with a non-VR distraction intervention. They will watch a nature video displayed on a tablet device during each burn dressing change session. This comparator is designed to control for the effects of distraction, allowing assessment of whether immersive VR provides additional benefit beyond conventional video distraction.

Behavioral: Nature Video Distraction (NVD)

Interventions

Immersive Virtual Reality Distraction (IVRD) BEHAVIORAL

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 change (approximately 10-15 minutes) and will be administered during every session. The VR system is calibrated to provide high levels of sensory immersion to effectively divert attention from painful stimuli.

VR Distraction

Nature Video Distraction (NVD) BEHAVIORAL

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 whether immersive VR provides additional benefit in reducing procedural pain and anxiety over a standard video distraction.

Nature Video Distraction

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al Hayah University In Cairo: lead

Study Sites (1)

Faculty of Physical Therapy, Al Hayah University

Cairo, 12111, Egypt

RECRUITING

MeSH Terms

Conditions

Burns; Pain, Procedural

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ibrahim Zoheiry, Ph.D

CONTACT

1277774949; ibrahim.alzoheiry@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to the participants' group assignments. Participants, care providers, and investigators will be aware of the intervention received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to one of two parallel arms evaluating two distraction strategies during burn dressing changes.

Study Record Dates

• First Submitted: March 30, 2025
• First Posted: April 6, 2025
• Study Start: April 12, 2025
• Primary Completion (Estimated): May 25, 2026
• Study Completion (Estimated): May 25, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)