Virtual Reality During Pediatric Cast Removal
ConditionFractures, Bone
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-12
SponsorGillette Children's Specialty Healthcare
About this trial
This study is a randomized control trial of Virtual Reality during cast removal procedures at a pediatric tertiary care center.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients with a history of epilepsy, ventricular shunt, motion sickness
Patients with any history of cognitive, visual or hearing impairment
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual Reality (VR)
DeviceParticipants in the experimental group will receive an AppliedVR virtual reality headset during their cast removal.
Treatment groups
184 Participants
are divided into 2 treatment groupsGroup A: Virtual RealityExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
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 outcomes
1
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.
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.2
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.
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.3
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.
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.4
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.
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.Sponsors and contacts
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Source ClinicalTrials.gov