Google Maps

NCT07740980

Overview

NCT ID: NCT07740980
Lead Sponsor: Mansoura UniversityOTHER
Official Title: Does Virtual Reality Reduce Pain, Fear, and Behavioral Distress in Children During Burn Dressing Changes? A Randomized Controlled Trial
Brief Summary: Burn injuries are very painful for children, especially during dressing changes when the wound is cleaned and re-bandaged. This procedure, while necessary, can cause pain, fear, and distress that may make children afraid of future treatments. Virtual reality (VR) is a technology that uses a headset to show an immersive, interactive 3D world. It can distract children from painful medical procedures.

This study aims to find out if using VR during burn dressing changes can reduce pain, fear, and behavioral distress in children aged 6 to 12 years. Half of the children will receive standard burn care plus VR distraction during their dressing change. The other half will receive standard care only.

The study will take place at the Burns and Plastic Surgery Center, Mansoura University, Egypt. Children will be recruited from both inpatient wards and outpatient clinics. Pain will be measured using a number scale, fear using a faces scale, and distress will be observed throughout the procedure.

It is expected that children who use VR will report less pain, show less fear, and display less distress during their dressing changes compared to children who receive standard care alone.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 3, 2026Actual
Start Date: Aug 1, 2026Estimated
Primary Completion Date: Oct 30, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Children aged 6 to 12 years

Acute burn injury requiring a routine dressing change, either during inpatient hospitalization or during a scheduled outpatient clinic visit

Able to communicate verbally and follow simple instructions

Medically stable as determined by attending physician (no acute respiratory distress, hemodynamic instability, or active sepsis)

Written informed consent from parent/guardian

Verbal child assent (for children aged 7 years and older)

Exclusion Criteria:

Burns involving the face, head, or ears that prevent safe VR headset placement

Cognitive, motor, visual, or hearing impairments interfering with study participation

History of motion sickness, seizure disorder, or migraines triggered by visual stimuli

Inability to maintain sitting or semi-upright position during the procedure

Burns greater than 60% Total Body Surface Area (TBSA) or requiring intensive care admission

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 80Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: Ahmed Hashem El-Monshed, PHDContact
ahmed_elmonshed@mans.edu.eg+201009976771

Similar Studies

Participant Group/Arms

VR Intervention GroupExperimental

Children in this arm will receive virtual reality (VR) distraction in addition to routine burn dressing care. The VR intervention will be initiated 2-3 minutes before the dressing change begins and will continue throughout the entire procedure. Children will wear a standalone VR headset with built-in speakers and a 3D display, viewing age-appropriate, interactive 3D content (e.g., games, underwater exploration, space adventures, or calming nature scenes). Children will be offered a choice of 2-3 VR experiences based on their preferences. The VR session may be paused if the child requests a break or experiences any adverse effects (nausea, dizziness, headache, or device discomfort). The researcher will remain present throughout the procedure to monitor the child's response and ensure safety.

Device: Virtual Reality (VR) Distraction

Other: Standard Burn Dressing Care

Standard Care Control GroupOther

Children in this arm will receive routine burn dressing care according to standard institutional protocol. This includes pre-procedural analgesic administration (according to hospital protocol), psychological preparation by nursing staff, standard wound care procedures (wound cleansing, debridement, and dressing application), and pharmacological pain management as clinically indicated. No structured distraction or non-pharmacological interventions beyond standard nursing care will be provided to this group.

Other: Standard Burn Dressing Care