VR for Lac Repairs in Peds Emergency Department

NCT06516003 | Completed

• 1 other identifier: 29-01-FB-0211
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the clinical trial is to compare virtual reality to standard of care for laceration repairs in the pediatric emergency department. The main question it aims to answer is:

• Does virtual reality decrease pain and anxiety scores compared to standard of care for laceration repairs in the pediatric emergency department? Participants who meet the age and other inclusion criteria will be enrolled by research staff. They will complete a brief paper survey along with their guardians and the provider doing the laceration repair. The surveys will be completed after the laceration repair is finished.

Conditions

Laceration

Keywords

virtual reality; pediatrics; emergency department

Outcome Measures

Primary Outcomes (2)

• Pain Score

  Using Wong Baker Faces Pain Scale

  Assessed immediately after intervention

• Fear Score

  Using Children's Fear Score

  Assessed immediately after intervention

Secondary Outcomes (6)

• Satisfaction of procedure

  Assessed immediately after intervention

• Side Effects

  Assessed immediately after intervention

• Duration of procedure

  Assessed immediately after intervention

• Future Use

  Assessed immediately after intervention

• Physical Holding

  Assessed immediately after intervention

Study Arms (2)

Virtual Reality

EXPERIMENTAL

Patients randomized to receive virtual reality goggles in addition to the standard of care.

Device: Immersive Virtual Reality Goggles

Standard of Care

ACTIVE COMPARATOR

Patients that are randomized to receive the standard of care including other distraction techniques and child life specialist.

Behavioral: Standard of Care

Interventions

Immersive Virtual Reality Goggles DEVICE

Immersive Virtual Reality goggles are a head mounted device placed over a patient's head and eyes that allows them to play in a virtual reality game.

Virtual Reality

Standard of Care BEHAVIORAL

Distraction techniques like tablet, phone, television, parent, child life specialist

Standard of Care

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Simple lacerations that do not require surgical subspecialty repair or moderate or deep sedation
• Hand lacerations
• Laceration that required stitches

You may not qualify if:

• less than 6 years old or greater than 17 years old
• Non english speaking
• Visual or hearing impairment
• Epilepsy
• Lacerations to forehead, nose, or cheeks where goggles cover
• Intellectual disability that precludes participation as determined by guardian

Sponsors & Collaborators

• Eastern Virginia Medical School: lead

Study Sites (1)

Children's Hospital of the King's Daughters

Norfolk, Virginia, 23507, United States

Location

Related Publications (21)

• Martin SR, Heyming TW, Fortier MA, Kain ZN. Paediatric laceration repair in the emergency department: post-discharge pain and maladaptive behavioural changes. Emerg Med J. 2024 Jul 22;41(8):469-474. doi: 10.1136/emermed-2023-213858.

  PMID: 38724104 BACKGROUND

• Ploghaus A, Narain C, Beckmann CF, Clare S, Bantick S, Wise R, Matthews PM, Rawlins JN, Tracey I. Exacerbation of pain by anxiety is associated with activity in a hippocampal network. J Neurosci. 2001 Dec 15;21(24):9896-903. doi: 10.1523/JNEUROSCI.21-24-09896.2001.

  PMID: 11739597 BACKGROUND

• Chan E, Hovenden M, Ramage E, Ling N, Pham JH, Rahim A, Lam C, Liu L, Foster S, Sambell R, Jeyachanthiran K, Crock C, Stock A, Hopper SM, Cohen S, Davidson A, Plummer K, Mills E, Craig SS, Deng G, Leong P. Virtual Reality for Pediatric Needle Procedural Pain: Two Randomized Clinical Trials. J Pediatr. 2019 Jun;209:160-167.e4. doi: 10.1016/j.jpeds.2019.02.034. Epub 2019 Apr 29.

  PMID: 31047650 BACKGROUND

• Kumar K, Ali S, Sabhaney V, Trottier E, Drendel A, Bhatt M, Boisvert L, Poonai N; Pediatric Emergency Research Canada. Anxiolysis for laceration repair in children: a survey of pediatric emergency providers in Canada. CJEM. 2022 Jan;24(1):75-83. doi: 10.1007/s43678-021-00210-y. Epub 2021 Nov 8.

  PMID: 34746980 BACKGROUND

• Ali S, McGrath T, Drendel AL. An Evidence-Based Approach to Minimizing Acute Procedural Pain in the Emergency Department and Beyond. Pediatr Emerg Care. 2016 Jan;32(1):36-42; quiz 43-4. doi: 10.1097/PEC.0000000000000669.

  PMID: 26720064 BACKGROUND

• Arikan A, Esenay FI. Active and Passive Distraction Interventions in a Pediatric Emergency Department to Reduce the Pain and Anxiety During Venous Blood Sampling: A Randomized Clinical Trial. J Emerg Nurs. 2020 Nov;46(6):779-790. doi: 10.1016/j.jen.2020.05.004. Epub 2020 Jul 22.

  PMID: 32711948 BACKGROUND

• Aykanat Girgin B, Gol I. Reducing Pain and Fear in Children During Venipuncture: A Randomized Controlled Study. Pain Manag Nurs. 2020 Jun;21(3):276-282. doi: 10.1016/j.pmn.2019.07.006. Epub 2019 Sep 26.

  PMID: 31501078 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

• 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

• Arane K, Behboudi A, Goldman RD. Virtual reality for pain and anxiety management in children. Can Fam Physician. 2017 Dec;63(12):932-934.

  PMID: 29237632 BACKGROUND

• Piskorz J, Czub M. Effectiveness of a virtual reality intervention to minimize pediatric stress and pain intensity during venipuncture. J Spec Pediatr Nurs. 2018 Jan;23(1). doi: 10.1111/jspn.12201. Epub 2017 Nov 20.

  PMID: 29155488 BACKGROUND

• Thomas JJ, Albietz J, Polaner D. Virtual reality for lumbar puncture in a morbidly obese patient with leukemia. Paediatr Anaesth. 2018 Nov;28(11):1059-1060. doi: 10.1111/pan.13505. Epub 2018 Oct 4.

  PMID: 30284748 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

• Chad R, Emaan S, Jillian O. Effect of virtual reality headset for pediatric fear and pain distraction during immunization. Pain Manag. 2018 May;8(3):175-179. doi: 10.2217/pmt-2017-0040. Epub 2018 May 3.

  PMID: 29722606 BACKGROUND

• Shetty V, Suresh LR, Hegde AM. Effect of Virtual Reality Distraction on Pain and Anxiety During Dental Treatment in 5 to 8 Year Old Children. J Clin Pediatr Dent. 2019;43(2):97-102. doi: 10.17796/1053-4625-43.2.5. Epub 2019 Feb 7.

  PMID: 30730798 BACKGROUND

• Jeffs D, Dorman D, Brown S, Files A, Graves T, Kirk E, Meredith-Neve S, Sanders J, White B, Swearingen CJ. Effect of virtual reality on adolescent pain during burn wound care. J Burn Care Res. 2014 Sep-Oct;35(5):395-408. doi: 10.1097/BCR.0000000000000019.

  PMID: 24823326 BACKGROUND

• Goldman RD, Behboudi A. Pilot Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care During Pediatric Laceration Repair. J Child Adolesc Trauma. 2021 Mar 26;14(2):295-298. doi: 10.1007/s40653-021-00350-4. eCollection 2021 Jun.

  PMID: 33986914 BACKGROUND

• Walther-Larsen S, Petersen T, Friis SM, Aagaard G, Drivenes B, Opstrup P. Immersive Virtual Reality for Pediatric Procedural Pain: A Randomized Clinical Trial. Hosp Pediatr. 2019 Jul;9(7):501-507. doi: 10.1542/hpeds.2018-0249. Epub 2019 Jun 3.

  PMID: 31160472 BACKGROUND

• Bexson C, Oldham G, Wray J. Safety of virtual reality use in children: a systematic review. Eur J Pediatr. 2024 May;183(5):2071-2090. doi: 10.1007/s00431-024-05488-5. Epub 2024 Mar 11.

  PMID: 38466416 BACKGROUND

• Neiman NR, Falkson SR, Rodriguez ST, Wang EY, Hemphill SF, Khoury ME, Kist MN, Jackson CD, Caruso TJ. Quantifying virtual reality pain modulation in healthy volunteers: A randomized, crossover study. J Clin Anesth. 2022 Sep;80:110876. doi: 10.1016/j.jclinane.2022.110876. Epub 2022 May 4.

  PMID: 35525050 BACKGROUND

• McEvoy AO, Vincent OB, Vazifedan T, Chang TP, Clingenpeel JM, Kapoor R. Virtual Reality as Active Distraction in Laceration Repair: A Game Changer? Pediatr Emerg Care. 2025 Mar 1;41(3):208-212. doi: 10.1097/PEC.0000000000003319. Epub 2024 Dec 6.

  PMID: 39641640 DERIVED

MeSH Terms

Conditions

Lacerations; Emergencies

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Wounds and Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 23, 2024
• Study Start: February 1, 2022
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)