Virtual Reality for Pain and Fear in Children With Burns

NCT07740980 | Not Yet Recruiting

• 1 other identifier: Mans06
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns; Pain, Procedural; Pain, Acute; Fear; Stress, Psychological

Keywords

Virtual Reality; VR; Distraction; Burn Dressing Change; Pediatric Pain; Procedural Pain; Child Fear; Behavioral Distress; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Pain Intensity

  Pain intensity will be measured using the Numeric Rating Scale (NRS), an 11-point self-report scale ranging from 0 ("no pain") to 10 ("the worst pain imaginable"). Children will be asked to select the number that best reflects the intensity of pain they experience during the burn dressing change procedure. The NRS is recommended for use with children aged 6 years and older and has demonstrated strong psychometric properties in pediatric populations. Scores are classified as follows: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain. The primary time point for the group comparison is immediately post-procedure, with baseline scores used as a covariate in the primary analysis.

  Baseline (pre-procedure) and immediately post-procedure

Secondary Outcomes (5)

• Behavioral Distress

  Continuously throughout the dressing change procedure at 15-second intervals

• Pulse Rate

  Baseline (pre-procedure), midway through the procedure, and immediately post-procedure

• Respiratory Rate

  Baseline (pre-procedure), midway through the procedure, and immediately post-procedure

• Oxygen Saturation (SpO₂)

  Baseline (pre-procedure), midway through the procedure, and immediately post-procedure

• Fear Level

  Baseline (pre-procedure) and immediately post-procedure

Study Arms (2)

VR Intervention Group

EXPERIMENTAL

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 Group

OTHER

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

Interventions

Virtual Reality (VR) Distraction DEVICE

A commercially available standalone VR headset with built-in speakers and a 3D display will be used to deliver immersive, interactive, age-appropriate content. The device will be adjusted for each child's head size to ensure comfort and safety. Children will view content selected from a curated library including: interactive games (e.g., age-appropriate puzzles and engaging activities); exploration experiences (e.g., underwater worlds, space adventures); and calming environments (e.g., nature scenes, relaxing landscapes). Children will be offered a choice of 2-3 age-appropriate VR experiences based on their preferences and developmental level to maximize engagement. The VR intervention will be initiated 2-3 minutes before the dressing change begins and will continue throughout the entire procedure

VR Intervention Group

Standard Burn Dressing Care OTHER

Routine burn dressing care provided according to standard institutional protocol at the Burns and Plastic Surgery Center, Mansoura University, Egypt. This includes: pre-procedural analgesic administration according to hospital protocol (e.g., oral or intravenous analgesics); psychological preparation by nursing staff; standard wound care procedures (wound cleansing, debridement, and dressing application); and pharmacological pain management as clinically indicated.

Standard Care Control Group; VR Intervention Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Burns and Plastic Surgery Center, Mansoura University

Al Mansurah, Egypt

Location

Related Publications (7)

• Shiferaw A, Mola S, Gashaw A, Sintayehu A. Evidence-based practical guideline for procedural pain management and sedation for burn pediatrics patients undergoing wound care procedures. Ann Med Surg (Lond). 2022 Sep 27;83:104756. doi: 10.1016/j.amsu.2022.104756. eCollection 2022 Nov.

  PMID: 36389198 BACKGROUND

• McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.

  PMID: 21806301 BACKGROUND

• Coban N, Goktas S, Sahi̇n F, Kose S. The effect of therapeutic storytelling on pain, fear, and anxiety levels in children undergoing burn dressing. Burns. 2025 Dec;51(9):107691. doi: 10.1016/j.burns.2025.107691. Epub 2025 Sep 2.

  PMID: 40934726 BACKGROUND

• Ciornei B, David VL, Popescu D, Boia ES. Pain Management in Pediatric Burns: A Review of the Science behind It. Glob Health Epidemiol Genom. 2023 Sep 15;2023:9950870. doi: 10.1155/2023/9950870. eCollection 2023.

  PMID: 37745034 BACKGROUND

• Cartotto R, Johnson LS, Savetamal A, Greenhalgh D, Kubasiak JC, Pham TN, Rizzo JA, Sen S, Main E. American Burn Association Clinical Practice Guidelines on Burn Shock Resuscitation. J Burn Care Res. 2024 May 6;45(3):565-589. doi: 10.1093/jbcr/irad125.

  PMID: 38051821 BACKGROUND

• Alkaissi, A., Rabou, N. A., Torman, M., Alroub, M. A., Awwad, I., & Said, N. B. (2025). The effect of a 360o educational video in a virtual reality on preoperative fear and postoperative pain in children undergoing tonsillectomy/adenoidectomy: a blind, randomized, controlled study. Egyptian Pediatric Association Gazette 2025 73:1, 73(1), 119-. https://doi.org/10.1186/S43054-025-00460-W

  BACKGROUND

• Alharran AM, AlAyyaf AE, Addar A, Hamdy R, Marwan Y. Virtual reality as a distraction technique in pediatric patients undergoing orthopedic procedures: A systematic review and meta-analysis of randomized controlled trials. J Child Orthop. 2026 Feb 25;20(3):285-293. doi: 10.1177/18632521251414463. eCollection 2026 Jun.

  PMID: 41769155 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Burns; Pain, Procedural; Acute Pain; Stress, Psychological

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ahmed Hashem El-Monshed, PHD

CONTACT

+201009976771; ahmed_elmonshed@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants, parents, and healthcare providers administering the intervention cannot be blinded due to the nature of the VR intervention. However, outcome assessors will be blinded to group allocation. Data analysts will also remain blinded until the final analysis is complete.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatric and Mental Health Nursing

Model Details: Two-arm, parallel-group randomized controlled trial with a 1:1 allocation ratio. Participants in the intervention arm receive VR distraction plus standard burn dressing care. Participants in the control arm receive standard burn dressing care alone.

Study Record Dates

• First Submitted: July 25, 2026
• First Posted: August 3, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)