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Virtual Reality During Pediatric Cast Removal

Primary Purpose

Fractures, Bone

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality (VR)
Sponsored by
Gillette Children's Specialty Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fractures, Bone focused on measuring Virtual Reality, Cast removal, Fracture

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gillette Children's Specialty HealthcareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Reality

Standard of care

Arm Description

Participants will experience Virtual Reality during their cast removal

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 27, 2019
Last Updated
February 10, 2021
Sponsor
Gillette Children's Specialty Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT03903510
Brief Title
Virtual Reality During Pediatric Cast Removal
Official Title
A Randomized Control Trial of Virtual Reality to Reduce Anxiety During Pediatric Cast Removal
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 21, 2019 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gillette Children's Specialty Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures, Bone
Keywords
Virtual Reality, Cast removal, Fracture

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
184 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality
Arm Type
Experimental
Arm Description
Participants will experience Virtual Reality during their cast removal
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Participants will receive their usual standard of care treatment during cast removal
Intervention Type
Device
Intervention Name(s)
Virtual Reality (VR)
Other Intervention Name(s)
AppliedVR
Intervention Description
Participants in the experimental group will receive an AppliedVR virtual reality headset during their cast removal.
Primary Outcome Measure Information:
Title
Change from baseline heart rate during cast removal procedure
Description
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.
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.
Secondary Outcome Measure Information:
Title
Change in Parent Reported Wong-Baker FACES Pain Scale Rating
Description
Parent reported pain scale that is rated from 0 (minimum) to 10 (maximum), where a higher number indicates increased pain.
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.
Title
Change in Patient Reported Wong-Baker FACES Pain Scale Rating
Description
Patient reported pain scale that is rated on a scale of 0 (minimum) to 10 (maximum), where a higher number indicates increased pain.
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.
Title
Visual Analog Scale (VAS): Parental anxiety during cast removal
Description
Parental anxiety will be self reported using a 0 (minimum) to 100 (maximum) scale, where a higher number indicates increased anxiety.
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.
Title
Visual Analog Scale (VAS): Patient anxiety during cast removal
Description
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.
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.
Title
Visual Analog Scale (VAS): Parental Satisfaction
Description
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.
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.
Title
Visual Analog Scale (VAS): Parental Assessment of Pleasantness
Description
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.
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.
Title
Visual Analog Scale (VAS): Parent Reported Worst Pain During Treatment
Description
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.
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.
Title
Visual Analog Scale (VAS): Patient Reported Worst Pain During Treatment
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew G Georgiadis, MD
Phone
651-602-3262
Email
andrewgeorgiadis@gillettechildrens.com
First Name & Middle Initial & Last Name or Official Title & Degree
Christine K Santa Ana, BS
Phone
651-229-1763
Email
ChristineKSantaAna@gillettechildrens.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew G Georgiadis, MD
Organizational Affiliation
Pediatric Orthopedic Surgeon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gillette Children's Specialty Healthcare
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew G Georgiadis, MD
Phone
651-602-3262
Email
andrewgeorgiadis@gillettechildrens.com
First Name & Middle Initial & Last Name & Degree
Christine K Santa Ana, BS
Phone
651-229-1763
Email
ChristineKSantaAna@gillettechildrens.com
First Name & Middle Initial & Last Name & Degree
Andrew G Georgiadis, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26177059
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.
Results Reference
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PubMed Identifier
8673584
Citation
Wiggins CE, Brown KD. Hearing protection and cast saw noise. J South Orthop Assoc. 1996 Spring;5(1):1-4.
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PubMed Identifier
11341425
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. doi: 10.1302/0301-620x.83b3.10487.
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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.
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Virtual Reality During Pediatric Cast Removal

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