Virtual Reality During Pediatric Cast Removal

Overview

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

Full Title of Study: “A Randomized Control Trial of Virtual Reality to Reduce Anxiety During Pediatric Cast Removal”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2020

Detailed 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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Virtual Reality
    • Participants will experience Virtual Reality during their cast removal
  • No Intervention: Standard of care
    • Participants will receive their usual standard of care treatment during cast removal

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline heart rate during cast removal procedure
    • Time Frame: 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.
    • 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.

Secondary Measures

  • Change in Parent Reported Wong-Baker FACES Pain Scale Rating
    • Time Frame: 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.
    • Parent reported pain scale that is rated from 0 (minimum) to 10 (maximum), where a higher number indicates increased pain.
  • Change in Patient Reported Wong-Baker FACES Pain Scale Rating
    • Time Frame: 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.
    • Patient reported pain scale that is rated on a scale of 0 (minimum) to 10 (maximum), where a higher number indicates increased pain.
  • Visual Analog Scale (VAS): Parental anxiety during cast removal
    • Time Frame: 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.
    • Parental anxiety will be self reported using a 0 (minimum) to 100 (maximum) scale, where a higher number indicates increased anxiety.
  • Visual Analog Scale (VAS): Patient anxiety during cast removal
    • Time Frame: 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.
    • 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.
  • Visual Analog Scale (VAS): Parental Satisfaction
    • Time Frame: 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.
    • 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.
  • Visual Analog Scale (VAS): Parental Assessment of Pleasantness
    • Time Frame: 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.
    • 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.
  • Visual Analog Scale (VAS): Parent Reported Worst Pain During Treatment
    • Time Frame: 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.
    • 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.
  • Visual Analog Scale (VAS): Patient Reported Worst Pain During Treatment
    • Time Frame: 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.
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 4 Years

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Gillette Children’s Specialty Healthcare
  • Provider of Information About this Clinical Study
    • Principal Investigator: Andrew G. Geoergiadis, Pediatric Orthopedic Surgeon – Gillette Children’s Specialty Healthcare
  • Overall Official(s)
    • Andrew G Georgiadis, MD, Principal Investigator, Pediatric Orthopedic Surgeon
  • Overall Contact(s)
    • Andrew G Georgiadis, MD, 651-602-3262, andrewgeorgiadis@gillettechildrens.com

References

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