Virtual Reality During Pediatric Cast Removal

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

Detailed Description
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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.

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

Conditions
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Fractures, Bone

Intervention / Treatment
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* Device: Virtual Reality (VR)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality<br>Participants will experience Virtual Reality during their cast removal | Device: Virtual Reality (VR)<br>* Participants in the experimental group will receive an AppliedVR virtual reality headset during their cast removal.<br>* Other names: AppliedVR;|
| No Intervention: Standard of care<br>Participants will receive their usual standard of care treatment during cast removal | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Cast removal, Fracture