Virtual Reality During Pediatric Cast Removal

Fractures, Bone Clinical Trial

Official title:

A Randomized Control Trial of Virtual Reality to Reduce Anxiety During Pediatric Cast Removal

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03903510
• Other study ID #: STUDY00005315
• Status: Recruiting
• Phase: N/A
• Start date: May 21, 2019
• Est. completion date: September 2021

Study information

• Verified date: February 2021
• Source: Gillette Children's Specialty Healthcare
• Contact: Andrew G Georgiadis, MD
• Phone: 651-602-3262
• Email: andrewgeorgiadis[@]gillettechildrens.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Cast removal is a common outpatient procedure and is a source of pain and anxiety for children. Children are often frightened by the appearance and the noise of the saw. Additionally, the saw blade can become warm, and this can be uncomfortable. Multiple methods have been used and studied to try to make this experience easier for children. These methods include: soft music, therapeutic play, and headphones. Virtual reality (VR) devices are now increasingly affordable and portable. VR could be a way to distract children from the appearance and sound of the procedure. VR has been used in other clinical settings to help patients with the anxiety associated with medical procedures. The investigators propose a randomized trial to assess the responses (e.g. questionnaires and monitors) of children to cast removal with VR versus the standard noise reduction headphones.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Fractures, Bone

Intervention

Device:
• Virtual Reality (VR)
Participants in the experimental group will receive an AppliedVR virtual reality headset during their cast removal.

Locations

Country	Name	City	State
United States	Gillette Children's Specialty Healthcare	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Gillette Children's Specialty Healthcare

Country where clinical trial is conducted

United States, 

References & Publications (19)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Hoffmann C. COX-2 in brain and spinal cord implications for therapeutic use. Curr Med Chem. 2000 Nov;7(11):1113-20. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Nilsson S, Finnström 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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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

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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Parent Reported Wong-Baker FACES Pain Scale Rating	Parent reported pain scale that is rated from 0 (minimum) to 10 (maximum), where a higher number indicates increased pain.	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.
Secondary	Change in Patient Reported Wong-Baker FACES Pain Scale Rating	Patient reported pain scale that is rated on a scale of 0 (minimum) to 10 (maximum), where a higher number indicates increased pain.	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.
Secondary	Visual Analog Scale (VAS): Parental anxiety during cast removal	Parental anxiety will be self reported using a 0 (minimum) to 100 (maximum) scale, where a higher number indicates increased anxiety.	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.
Secondary	Visual Analog Scale (VAS): Patient anxiety during cast removal	Patient anxiety regarding the cast removal will be self reported using a 0 (minimum) to 100 (maximum) scale, where a higher number indicates increased anxiety.	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.
Secondary	Visual Analog Scale (VAS): Parental Satisfaction	Parental satisfaction regarding the cast removal will be self reported using a 0 (minimum) to 100 (maximum) scale, where a higher number indicates increased 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.
Secondary	Visual Analog Scale (VAS): Parental Assessment of Pleasantness	Parental report of how pleasant the cast removal was. Self reported using a 0 (minimum) to 100 (maximum) scale, where a higher number indicates increased pleasantness.	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.
Secondary	Visual Analog Scale (VAS): Parent Reported Worst Pain During Treatment	Parental report of the highest level of pain experienced by the child during the cast removal. Reported using a 0 (minimum) to 100 (maximum) scale, where a higher number indicates increased pain.	The VAS parental worst pain 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.
Secondary	Visual Analog Scale (VAS): Patient Reported Worst Pain During Treatment	Patient report of the highest level of pain experienced by the child during the cast removal. Reported using a 0 (minimum) to 100 (maximum) scale, where a higher number indicates increased pain.	The VAS patient worst pain 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.