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

Not Applicable

Recruiting

• Conditions: Burns; Burn Wound; Procedural Pain; Anxiety Acute

• Registration Number: NCT06913270
• Lead Sponsor: Al Hayah University In Cairo

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).

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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-30
• Study First Submitted QC: 2025-03-30
• Last Update Submitted: 2025-03-30
• Study First Posted: 2025-04-06
• Last Update Posted: 2025-04-06
• Study Start: 2025-04-12
• Primary Completion: 2026-05-25
• Study Completion: 2026-05-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.	The SF-36 Health Survey is a comprehensive, validated instrument designed to measure quality of life across eight domains, including physical functioning, bodily pain, general health perceptions, vitality, social functioning, role limitations due to physical and emotional problems, and mental health. This will provide insight into the broader impact of burn injuries and recovery over time.
Range of Motion (ROM) Measurements	Measurements will be recorded at baseline and at follow-up visits at 3, 6, and 12 months.	Range of motion (ROM) in the affected areas will be assessed using standardized goniometry. This measurement quantifies physical mobility and joint function, providing objective data on the physical recovery and potential functional limitations post-burn injury.
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.	The Hospital Anxiety and Depression Scale (HADS) is a validated self-report questionnaire used to assess anxiety and depressive symptoms. Improving psychological well-being is a key aspect of overall recovery for burn survivors.

Trial Locations

Locations (1)

Faculty of Physical Therapy, Al Hayah University; 🇪🇬 Cairo, Egypt