Virtual Reality, Pain, Clinical Outcomes, Hydrotherapy, Children, Burn

NCT06160518 | Completed

• 1 other identifier: 0517
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effect of virtual reality on pain and clinical outcomes during hydrotherapy for children with burn.

Conditions

Burn; Hydrotherapy

Keywords

Virtual Reality; Pain; Clinical Outcomes; Hydrotherapy; Children; Burn

Outcome Measures

Primary Outcomes (4)

• Physiological parameters assessment sheet: respiratory rate

  cycle per minure

  • 10 minutes before hydrotherapy session. • 5 minutes after hydrotherapy session started without VR. • 5 minutes after hydrotherapy session started using VR. • Immediately before hydrotherapy session VR. • 10 minutes after the hydrotherapy session.

• Physiological parameters assessment sheet heart rate

  beat per minute

  • 10 minutes before hydrotherapy session. • 5 minutes after hydrotherapy session started without VR. • 5 minutes after hydrotherapy session started using VR. • Immediately before hydrotherapy session VR. • 10 minutes after the hydrotherapy session.

• Physiological parameters assessment sheet:O2 saturation.

  More than 95%

  • 10 minutes before hydrotherapy session. • 5 minutes after hydrotherapy session started without VR. • 5 minutes after hydrotherapy session started using VR. • Immediately before hydrotherapy session VR. • 10 minutes after the hydrotherapy session.

• The clinical data assessment sheet:cause of burn, total body surface area burned, location of the burn, number of wounds, and the number of hydrotherapy sessions already undergoing.

  clinical data

  • 10 minutes before hydrotherapy session. .

Secondary Outcomes (1)

• Pain Assessment Scale

  • 10 minutes before hydrotherapy session. • 5 minutes after hydrotherapy session started without VR. • 5 minutes after hydrotherapy session started using VR. • Immediately before hydrotherapy session VR. • 10 minutes after the hydrotherapy session.

Study Arms (2)

Control

NO INTERVENTION

The children will receive the standard pharmacological treatment of the unit to manage pain and stabilize their physiological parameters throughout the three days of study.

Study group

EXPERIMENTAL

The children will receive virtual reality intervention which will take place using a cell phone coupled with the three-dimensional image glasses. The cell phone will play three-dimensional games which will be downloaded for free. The options for images and games involved which children could choose freely, all games will be suitable for the age group of the study.

Behavioral: Virtual reality

Interventions

Virtual reality BEHAVIORAL

artificial construction of 3D environment via mobile technology. It included a head-mounted device (HMD) with 3D-enabled goggles, sensory input devices and headphones, which together allow a multisensory experience to divert a child's attention.

Study group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged from 3-6 years.
• Children who do not have a burned face.
• Undergoing hydrotherapy procedure for wound care.
• Able to score their own pain, with or without a visual tool.
• Willing to participate in the study.

You may not qualify if:

• Are cognitive or visual impairment.
• Received strong pain killer or sedative medication.

Sponsors & Collaborators

• Matrouh University: lead

Study Sites (1)

Matrouh university

Marsá Maţrūḩ, Egypt

Location

Related Publications (25)

• Ali RR, Selim AO, Abdel Ghafar MA, Abdelraouf OR, Ali OI. Virtual reality as a pain distractor during physical rehabilitation in pediatric burns. Burns. 2022 Mar;48(2):303-308. doi: 10.1016/j.burns.2021.04.031. Epub 2021 May 5.

  PMID: 34154898 BACKGROUND

• Ang SP, Montuori M, Trimba Y, Maldari N, Patel D, Chen QC. Recent Applications of Virtual Reality for the Management of Pain in Burn and Pediatric Patients. Curr Pain Headache Rep. 2021 Jan 14;25(1):4. doi: 10.1007/s11916-020-00917-0.

  PMID: 33443603 BACKGROUND

• Centers for Disease Control and Prevention [CDC], (2019). WISQARS data visualization. Available at: https://wisqars-viz.cdc.gov:8006/lcd/home (Accessed on 1 August 2023)

  BACKGROUND

• D'Alessandro, L.N., Corrales, I.L., Klein, S., Kondo, D., & Stinson, J. (2022). Using virtual reality distraction during wound management: A brief case report in a patient with epidermolysis bullosa. Pediatric Pain Letter,24(1):1-7.

  BACKGROUND

• Dumoulin S, Bouchard S, Ellis J, Lavoie KL, Vezina MP, Charbonneau P, Tardif J, Hajjar A. A Randomized Controlled Trial on the Use of Virtual Reality for Needle-Related Procedures in Children and Adolescents in the Emergency Department. Games Health J. 2019 Aug;8(4):285-293. doi: 10.1089/g4h.2018.0111. Epub 2019 May 24.

  PMID: 31135178 BACKGROUND

• Eijlers R, Utens EMWJ, Staals LM, de Nijs PFA, Berghmans JM, Wijnen RMH, Hillegers MHJ, Dierckx B, Legerstee JS. Systematic Review and Meta-analysis of Virtual Reality in Pediatrics: Effects on Pain and Anxiety. Anesth Analg. 2019 Nov;129(5):1344-1353. doi: 10.1213/ANE.0000000000004165.

  PMID: 31136330 BACKGROUND

• Elrod J, Schiestl CM, Mohr C, Landolt MA. Incidence, severity and pattern of burns in children and adolescents: An epidemiological study among immigrant and Swiss patients in Switzerland. Burns. 2019 Aug;45(5):1231-1241. doi: 10.1016/j.burns.2019.02.009. Epub 2019 May 13.

  PMID: 31097353 BACKGROUND

• Garrido-Ardila EM, Santos-Dominguez M, Rodriguez-Mansilla J, Torres-Piles ST, Rodriguez-Dominguez MT, Gonzalez-Sanchez B, Jimenez-Palomares M. A Systematic Review of the Effectiveness of Virtual Reality-Based Interventions on Pain and Range of Joint Movement Associated with Burn Injuries. J Pers Med. 2022 Jul 31;12(8):1269. doi: 10.3390/jpm12081269.

  PMID: 36013218 BACKGROUND

• Gerceker GO, Bektas M, Aydinok Y, Oren H, Ellidokuz H, Olgun N. The effect of virtual reality on pain, fear, and anxiety during access of a port with huber needle in pediatric hematology-oncology patients: Randomized controlled trial. Eur J Oncol Nurs. 2021 Feb;50:101886. doi: 10.1016/j.ejon.2020.101886. Epub 2020 Dec 1.

  PMID: 33321461 BACKGROUND

• Hansen JK, Voss J, Ganatra H, Langner T, Chalise P, Stokes S, Bhavsar D, Kovac AL. Sedation and Analgesia During Pediatric Burn Dressing Change: A Survey of American Burn Association Centers. J Burn Care Res. 2019 Apr 26;40(3):287-293. doi: 10.1093/jbcr/irz023.

  PMID: 30844056 BACKGROUND

• Hoffman HG, Rodriguez RA, Gonzalez M, Bernardy M, Pena R, Beck W, Patterson DR, Meyer WJ 3rd. Immersive Virtual Reality as an Adjunctive Non-opioid Analgesic for Pre-dominantly Latin American Children With Large Severe Burn Wounds During Burn Wound Cleaning in the Intensive Care Unit: A Pilot Study. Front Hum Neurosci. 2019 Aug 8;13:262. doi: 10.3389/fnhum.2019.00262. eCollection 2019.

  PMID: 31440148 BACKGROUND

• Jeschke MG, van Baar ME, Choudhry MA, Chung KK, Gibran NS, Logsetty S. Burn injury. Nat Rev Dis Primers. 2020 Feb 13;6(1):11. doi: 10.1038/s41572-020-0145-5.

  PMID: 32054846 BACKGROUND

• Khadra C, Ballard A, Dery J, Paquin D, Fortin JS, Perreault I, Labbe DR, Hoffman HG, Bouchard S, LeMay S. Projector-based virtual reality dome environment for procedural pain and anxiety in young children with burn injuries: a pilot study. J Pain Res. 2018 Feb 14;11:343-353. doi: 10.2147/JPR.S151084. eCollection 2018.

  PMID: 29491717 BACKGROUND

• Khadra C, Ballard A, Paquin D, Cotes-Turpin C, Hoffman HG, Perreault I, Fortin JS, Bouchard S, Theroux J, Le May S. Effects of a projector-based hybrid virtual reality on pain in young children with burn injuries during hydrotherapy sessions: A within-subject randomized crossover trial. Burns. 2020 Nov;46(7):1571-1584. doi: 10.1016/j.burns.2020.04.006. Epub 2020 May 7.

  PMID: 32389349 BACKGROUND

• LoBiondo-Wood, G., Haber, J., & Titler, M. G. (2018). Evidence-based practice for nursing and healthcare quality improvement. Elsevier Health Sciences.

  BACKGROUND

• McDonnell N. Immersive Technology and Medical Visualisation: A Users Guide. Adv Exp Med Biol. 2019;1156:123-134. doi: 10.1007/978-3-030-19385-0_9.

  PMID: 31338782 BACKGROUND

• Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available.

  PMID: 5320816 BACKGROUND

• Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.

  PMID: 9220806 BACKGROUND

• Norouzkhani N, Chaghian Arani R, Mehrabi H, Bagheri Toolaroud P, Ghorbani Vajargah P, Mollaei A, Hosseini SJ, Firooz M, Falakdami A, Takasi P, Feizkhah A, Saber H, Ghaffarzade H, Nemalhabib A, Ghaffari A, Osuji J, Mobayen M, Karkhah S. Effect of Virtual Reality-Based Interventions on Pain During Wound Care in Burn Patients; a Systematic Review and Meta-Analysis. Arch Acad Emerg Med. 2022 Oct 24;10(1):e84. doi: 10.22037/aaem.v10i1.1756. eCollection 2022.

  PMID: 36426174 BACKGROUND

• Scapin S, Echevarria-Guanilo ME, Boeira Fuculo Junior PR, Goncalves N, Rocha PK, Coimbra R. Virtual Reality in the treatment of burn patients: A systematic review. Burns. 2018 Sep;44(6):1403-1416. doi: 10.1016/j.burns.2017.11.002. Epub 2018 Feb 1.

  PMID: 29395400 BACKGROUND

• Smith KL, Wang Y, Colloca L. Impact of Virtual Reality Technology on Pain and Anxiety in Pediatric Burn Patients: A Systematic Review and Meta-Analysis. Front Virtual Real. 2022 Jan;2:751735. doi: 10.3389/frvir.2021.751735. Epub 2022 Jan 6.

  PMID: 36247202 BACKGROUND

• Sohn D, Ring D, Toy KA, Julian JA, Arnstein P. Pain Relief and the Opioid Crisis in the United States and Canada. Instr Course Lect. 2019;68:639-646.

  PMID: 32032104 BACKGROUND

• Won AS, Bailey J, Bailenson J, Tataru C, Yoon IA, Golianu B. Immersive Virtual Reality for Pediatric Pain. Children (Basel). 2017 Jun 23;4(7):52. doi: 10.3390/children4070052.

  PMID: 28644422 BACKGROUND

• World Health Organization [WHO], (2018). Burns. Available at: https://www.who.int/en/news-room/fact-sheets/detail/burns (Accessed on 30 July 2023)

  BACKGROUND

• Xiang H, Shen J, Wheeler KK, Patterson J, Lever K, Armstrong M, Shi J, Thakkar RK, Groner JI, Noffsinger D, Giles SA, Fabia RB. Efficacy of Smartphone Active and Passive Virtual Reality Distraction vs Standard Care on Burn Pain Among Pediatric Patients: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jun 1;4(6):e2112082. doi: 10.1001/jamanetworkopen.2021.12082.

  PMID: 34152420 BACKGROUND

MeSH Terms

Conditions

Burns; Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of pediatric nursing

Model Details: virtual reality intervention which will take place using a cell phone coupled with the three-dimensional image glasses. The cell phone will play three-dimensional games which will be downloaded for free. The options for images and games involved which children could choose freely, all games will be suitable for the age group of the study. • The intervention will be applied for three days when hydrotherapy session done

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: December 7, 2023
• Study Start: July 27, 2023
• Primary Completion: December 25, 2023
• Study Completion: December 30, 2023
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)