Clinical trial NCT03903510: 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
Overall status: RECRUITING
Phase: NA
Conditions: Fractures, Bone
Keywords: Virtual Reality
Cast removal
Fracture
Lead sponsor: Gillette Children's Specialty Healthcare
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 184
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change from baseline heart rate during cast removal procedure
timeFrame: 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 outcomes:
measure: Change in Parent Reported Wong-Baker FACES Pain Scale Rating
timeFrame: 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.
measure: Change in Patient Reported Wong-Baker FACES Pain Scale Rating
timeFrame: 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.
measure: Visual Analog Scale (VAS): Parental anxiety during cast removal
timeFrame: 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.
measure: Visual Analog Scale (VAS): Patient anxiety during cast removal
timeFrame: 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.
measure: Visual Analog Scale (VAS): Parental Satisfaction
timeFrame: 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.
measure: Visual Analog Scale (VAS): Parental Assessment of Pleasantness
timeFrame: 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.
measure: Visual Analog Scale (VAS): Parent Reported Worst Pain During Treatment
timeFrame: 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.
measure: Visual Analog Scale (VAS): Patient Reported Worst Pain During Treatment
timeFrame: 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.
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Gillette Children's Specialty Healthcare
state: Minnesota
Study officials:
affiliation: Pediatric Orthopedic Surgeon
name: Andrew G Georgiadis, MD
role: PRINCIPAL_INVESTIGATOR
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