Clinical trial NCT06913270: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Burns
Burn Wound
Procedural Pain
Anxiety Acute
Lead sponsor: Al Hayah University In Cairo
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to one of two parallel arms evaluating two distraction strategies during burn dressing changes.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Functional Status via Burn Specific Health Scale - Brief (BSHS-B)
timeFrame: Assessments will be conducted at baseline (within 2 weeks post-discharge) and at follow-up visits at 3, 6, and 12 months.
measure: Return-to-Work Rate
timeFrame: Assessed at 12 months post-discharge.
Secondary outcomes:
measure: Quality of Life (QoL) via SF-36 Health Survey
timeFrame: Evaluations will occur at baseline (within 2 weeks post-discharge) and at 3, 6, and 12 months follow-up.
measure: Range of Motion (ROM) Measurements
timeFrame: Measurements will be recorded at baseline and at follow-up visits at 3, 6, and 12 months.
measure: Psychological Well-Being via Hospital Anxiety and Depression Scale (HADS)
timeFrame: HADS assessments will be administered at baseline (within 2 weeks post-discharge) and then at 3, 6, and 12 months follow-up.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy, Al Hayah University
Study officials:
References: