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Mira Prism VR for Pain
N/A
Waitlist Available
Led By Jeffrey I Gold, PhD
Research Sponsored by Children's Hospital Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 5 minutes to one hour before procedure
Awards & highlights
Study Summary
This trial will test whether virtual reality can help reduce pain and anxiety in children during medical procedures.
Eligible Conditions
- Pain
- Mask Induction
- Outpatient Surgery
- Anxiety
- Virtual Reality
- Augmented Reality
- Intravenous (IV) Stick
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 5 minutes to one hour before procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 5 minutes to one hour before procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
6-item self-report measure of healthcare provider's perceptions about the child's cooperation, distress, and anxiety
Anxiety
CAMPIS-R
+9 moreSecondary outcome measures
Analgesic Requirements
Behavior Assessment System for Children (BASC-2)
Blood pressure and heart rate (BP/ HR)
+5 moreOther outcome measures
Demographic Survey
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: VR RandomizationExperimental Treatment2 Interventions
When a child is assigned to the VR condition s/he will have the added component of VR distraction during pre-surgical preparation. Children in the VR condition will interact with an immersive 3D virtual environment presented via a HMD (head-mounted display), a helmet with computer screens for each eye. This study will use two HMDs at two possible time points: (1) Prior to and during IV placement, participants will play using the Oculus Go; (2) Prior to and during anesthesia induction, participants will play using the Mira Prism.
Group II: Standard of Care (No VR) RandomizationActive Control1 Intervention
In the standard of care treatment condition, participants will receive the standard CHLA treatment protocol for IV placement and induction of anesthesia. Current standard of care practices at CHLA for outpatient surgery induction will include the following steps. Children may receive midazolam, parental presence during induction and any other intervention or medication chosen by the HCP. The research team will have no input to the decision regarding the use of any therapy.
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Who is running the clinical trial?
Children's Hospital Los AngelesLead Sponsor
231 Previous Clinical Trials
5,076,178 Total Patients Enrolled
4 Trials studying Pain
1,840 Patients Enrolled for Pain
AppliedVR Inc.Industry Sponsor
10 Previous Clinical Trials
2,621 Total Patients Enrolled
1 Trials studying Pain
700 Patients Enrolled for Pain
Jeffrey I Gold, PhDPrincipal InvestigatorChildren's Hospital Los Angeles
3 Previous Clinical Trials
828 Total Patients Enrolled
1 Trials studying Pain
700 Patients Enrolled for Pain
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