Virtual Reality During Pediatric Cast Removal

NCT03903510 | Recruiting FDA Device

• 1 other identifier: STUDY00005315
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized control trial of Virtual Reality during cast removal procedures at a pediatric tertiary care center.

Conditions

Fractures, Bone

Keywords

Virtual Reality; Cast removal; Fracture

Outcome Measures

Primary Outcomes (1)

• Change from baseline heart rate during cast removal procedure

  The change from baseline heart rate during cast removal procedure obtained by using an electronic monitoring wristband and measuring heart rate 15 seconds prior to and continuously during the cast removal procedure.

  Heart rate will be measured during the cast removal procedure. As this is a single visit study, heart rate will not be measured at any other time periods throughout the study.

Secondary Outcomes (8)

• Change in Parent Reported Wong-Baker FACES Pain Scale Rating

  The Wong-Baker FACES Pain Scale assessment will be collected 1 minute prior to and immediately after cast removal.This is a single visit study and the assessment will not be measured at any other time periods.

• Change in Patient Reported Wong-Baker FACES Pain Scale Rating

  The Wong-Baker FACES Pain Scale assessment will be collected 1 minute prior to and immediately after cast removal.This is a single visit study and the assessment will not be measured at any other time periods.

• Visual Analog Scale (VAS): Parental anxiety during cast removal

  The VAS anxiety assessment will be performed immediately after the cast removal procedure, which is expected to last 5-10 minutes.This is a single visit study and the assessment will not be measured at any other time periods.

• Visual Analog Scale (VAS): Patient anxiety during cast removal

  The VAS anxiety assessment will be performed immediately after the cast removal procedure, which is expected to last 5-10 minutes.This is a single visit study and the assessment will not be measured at any other time periods.

• Visual Analog Scale (VAS): Parental Satisfaction

  The VAS parental satisfaction assessment will be performed immediately after the cast removal procedure, which is expected to last 5-10 minutes.This is a single visit study and the assessment will not be measured at any other time periods.

Study Arms (2)

Virtual Reality

EXPERIMENTAL

Participants will experience Virtual Reality during their cast removal

Device: Virtual Reality (VR)

Standard of care

NO INTERVENTION

Participants will receive their usual standard of care treatment during cast removal

Interventions

Virtual Reality (VR) DEVICE

Participants in the experimental group will receive an AppliedVR virtual reality headset during their cast removal.

Also known as: AppliedVR

Virtual Reality

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Sustained a fracture in their arm/leg
• No previous experience with a cast removal
• Must have at least one wrist free of immobilization (for heart rate monitor)
• Parents and patient are English speaking

You may not qualify if:

• Patients with a history of epilepsy, ventricular shunt, motion sickness
• Patients with any history of cognitive, visual or hearing impairment

Sponsors & Collaborators

• Gillette Children's Specialty Healthcare: lead

Study Sites (1)

Gillette Children's Specialty Healthcare

Saint Paul, Minnesota, 55101, United States

RECRUITING

Related Publications (19)

• Naranje SM, Erali RA, Warner WC Jr, Sawyer JR, Kelly DM. Epidemiology of Pediatric Fractures Presenting to Emergency Departments in the United States. J Pediatr Orthop. 2016 Jun;36(4):e45-8. doi: 10.1097/BPO.0000000000000595.

  PMID: 26177059 BACKGROUND

• Wiggins CE, Brown KD. Hearing protection and cast saw noise. J South Orthop Assoc. 1996 Spring;5(1):1-4.

  PMID: 8673584 BACKGROUND

• Katz K, Fogelman R, Attias J, Baron E, Soudry M. Anxiety reaction in children during removal of their plaster cast with a saw. J Bone Joint Surg Br. 2001 Apr;83(3):388-90. doi: 10.1302/0301-620x.83b3.10487.

  PMID: 11341425 BACKGROUND

• Post JM, Switzer KD, Brown DK, Meinzen-Derr J, Dively J, Dunkin BS, Mehlman CT. Cast saw noise does not reach occupational hazard levels. J Pediatr Orthop. 2013 Jul-Aug;33(5):580-4. doi: 10.1097/BPO.0b013e318288b5e4.

  PMID: 23752160 BACKGROUND

• Liu RW, Mehta P, Fortuna S, Armstrong DG, Cooperman DR, Thompson GH, Gilmore A. A randomized prospective study of music therapy for reducing anxiety during cast room procedures. J Pediatr Orthop. 2007 Oct-Nov;27(7):831-3. doi: 10.1097/BPO.0b013e3181558a4e.

  PMID: 17878794 BACKGROUND

• Wong CL, Ip WY, Kwok BMC, Choi KC, Ng BKW, Chan CWH. Effects of therapeutic play on children undergoing cast-removal procedures: a randomised controlled trial. BMJ Open. 2018 Jul 5;8(7):e021071. doi: 10.1136/bmjopen-2017-021071.

  PMID: 29980545 BACKGROUND

• Carmichael KD, Westmoreland J. Effectiveness of ear protection in reducing anxiety during cast removal in children. Am J Orthop (Belle Mead NJ). 2005 Jan;34(1):43-6.

  PMID: 15707139 BACKGROUND

• Mahan ST, Harris MS, Lierhaus AM, Miller PE, DiFazio RL. Noise Reduction to Reduce Patient Anxiety During Cast Removal: Can We Decrease Patient Anxiety With Cast Removal by Wearing Noise Reduction Headphones During Cast Saw Use? Orthop Nurs. 2017 Jul/Aug;36(4):271-278. doi: 10.1097/NOR.0000000000000365.

  PMID: 28737634 BACKGROUND

• Hoffmann C. COX-2 in brain and spinal cord implications for therapeutic use. Curr Med Chem. 2000 Nov;7(11):1113-20. doi: 10.2174/0929867003374282.

  PMID: 11032961 BACKGROUND

• Gold JI, Kim SH, Kant AJ, Joseph MH, Rizzo AS. Effectiveness of virtual reality for pediatric pain distraction during i.v. placement. Cyberpsychol Behav. 2006 Apr;9(2):207-12. doi: 10.1089/cpb.2006.9.207.

  PMID: 16640481 BACKGROUND

• Asl Aminabadi N, Erfanparast L, Sohrabi A, Ghertasi Oskouei S, Naghili A. The Impact of Virtual Reality Distraction on Pain and Anxiety during Dental Treatment in 4-6 Year-Old Children: a Randomized Controlled Clinical Trial. J Dent Res Dent Clin Dent Prospects. 2012 Fall;6(4):117-24. doi: 10.5681/joddd.2012.025. Epub 2012 Nov 12.

  PMID: 23277857 BACKGROUND

• Nilsson S, Finnstrom B, Kokinsky E. The FLACC behavioral scale for procedural pain assessment in children aged 5-16 years. Paediatr Anaesth. 2008 Aug;18(8):767-74. doi: 10.1111/j.1460-9592.2008.02655.x.

  PMID: 18613934 BACKGROUND

• Steele E, Grimmer K, Thomas B, Mulley B, Fulton I, Hoffman H. Virtual reality as a pediatric pain modulation technique: a case study. Cyberpsychol Behav. 2003 Dec;6(6):633-8. doi: 10.1089/109493103322725405.

  PMID: 14756928 BACKGROUND

• Hoffman HG, Doctor JN, Patterson DR, Carrougher GJ, Furness TA 3rd. Virtual reality as an adjunctive pain control during burn wound care in adolescent patients. Pain. 2000 Mar;85(1-2):305-9. doi: 10.1016/s0304-3959(99)00275-4.

  PMID: 10692634 BACKGROUND

• Hoffman HG, Patterson DR, Carrougher GJ. Use of virtual reality for adjunctive treatment of adult burn pain during physical therapy: a controlled study. Clin J Pain. 2000 Sep;16(3):244-50. doi: 10.1097/00002508-200009000-00010.

  PMID: 11014398 BACKGROUND

• Sharar SR, Miller W, Teeley A, Soltani M, Hoffman HG, Jensen MP, Patterson DR. Applications of virtual reality for pain management in burn-injured patients. Expert Rev Neurother. 2008 Nov;8(11):1667-74. doi: 10.1586/14737175.8.11.1667.

  PMID: 18986237 BACKGROUND

• Hoffman HG, Seibel EJ, Richards TL, Furness TA, Patterson DR, Sharar SR. Virtual reality helmet display quality influences the magnitude of virtual reality analgesia. J Pain. 2006 Nov;7(11):843-50. doi: 10.1016/j.jpain.2006.04.006.

  PMID: 17074626 BACKGROUND

• Schmitt YS, Hoffman HG, Blough DK, Patterson DR, Jensen MP, Soltani M, Carrougher GJ, Nakamura D, Sharar SR. A randomized, controlled trial of immersive virtual reality analgesia, during physical therapy for pediatric burns. Burns. 2011 Feb;37(1):61-8. doi: 10.1016/j.burns.2010.07.007. Epub 2010 Aug 7.

  PMID: 20692769 BACKGROUND

• Hoffman HG, Sharar SR, Coda B, Everett JJ, Ciol M, Richards T, Patterson DR. Manipulating presence influences the magnitude of virtual reality analgesia. Pain. 2004 Sep;111(1-2):162-8. doi: 10.1016/j.pain.2004.06.013.

  PMID: 15327820 BACKGROUND

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Andrew G Georgiadis, MD

  Pediatric Orthopedic Surgeon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew G Georgiadis, MD

CONTACT

651-602-3262; andrewgeorgiadis@gillettechildrens.com

Christine K Santa Ana, BS

CONTACT

651-229-1763; ChristineKSantaAna@gillettechildrens.com

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: Pediatric Orthopedic Surgeon

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: April 4, 2019
• Study Start: May 21, 2019
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: February 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)