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Virtual Reality During Pediatric Cast Removal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03903510
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Andrew G. Geoergiadis, Gillette Children's Specialty Healthcare

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

Condition or disease Intervention/treatment Phase
Fractures, Bone Device: Virtual Reality (VR) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomized Control Trial of Virtual Reality to Reduce Anxiety During Pediatric Cast Removal
Actual Study Start Date : May 21, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Fractures

Arm Intervention/treatment
Experimental: Virtual Reality
Participants will experience Virtual Reality during their cast removal
Device: Virtual Reality (VR)
Participants in the experimental group will receive an AppliedVR virtual reality headset during their cast removal.
Other Name: AppliedVR

No Intervention: Standard of care
Participants will receive their usual standard of care treatment during cast removal



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903510


Contacts
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Contact: Andrew G Georgiadis, MD 651-602-3262 andrewgeorgiadis@gillettechildrens.com
Contact: Trever M Koester, BS 651-229-1763 trevermkoester@gillettechildrens.com

Locations
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United States, Minnesota
Gillette Children's Specialty Healthcare Recruiting
Saint Paul, Minnesota, United States, 55101
Contact: Andrew G Georgiadis, MD    651-602-3262    andrewgeorgiadis@gillettechildrens.com   
Contact: Trever M Koester, BS    651-229-1763    trevermkoester@gillettechildrens.com   
Principal Investigator: Andrew G Georgiadis, MD         
Sponsors and Collaborators
Gillette Children's Specialty Healthcare
Investigators
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Principal Investigator: Andrew G Georgiadis, MD Pediatric Orthopedic Surgeon
Publications:

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Responsible Party: Andrew G. Geoergiadis, Pediatric Orthopedic Surgeon, Gillette Children's Specialty Healthcare
ClinicalTrials.gov Identifier: NCT03903510    
Other Study ID Numbers: STUDY00005315
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Andrew G. Geoergiadis, Gillette Children's Specialty Healthcare:
Virtual Reality
Cast removal
Fracture
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries