Status:
TERMINATED
Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Pediatric Patients for Pain Control
Lead Sponsor:
Montefiore Medical Center
Collaborating Sponsors:
American Academy of Physical Medicine and Rehabilitation
Conditions:
Pain
Eligibility:
All Genders
5-18 years
Phase:
NA
Brief Summary
To evaluate the efficacy of virtual reality analgesia (VRA) for pediatric patients undergoing Botulinum toxin injections (BTI) for spasticity management. Patients will be assigned to one of three grou...
Detailed Description
Group 1: Oculus Rift This group will receive BTI's per conventional protocols. They will wear the Oculus Rift VRHMD (Figure 1\) powered by the laptop pc (Figure 2) during the procedure viewing a VR 3...
Eligibility Criteria
Inclusion
- Children with spasticity requiring BTI
- Children ages 5 - 18
- Children who have contraindications for sedation for BTI
- Children with intact vision who can attend VR intervention
Exclusion
- Children who have uncontrolled seizures \> than 4 per year
- Children who are not attentive to VR secondary to poor concentration, poor cognition to external stimuli
- Children on different treatments for spasticity such as baclofen pump, phenol block. For patients who receive phenol block, phenol block will be held during the visits with VR intervention to avoid confounding results
- Children with poor bleeding control
- Children who request general anesthesia/IV sedation.
Key Trial Info
Start Date :
July 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2023
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT03480724
Start Date
July 6 2017
End Date
October 27 2023
Last Update
January 5 2024
Active Locations (1)
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1
E-MMC - Rehabilitation Medicine, The Arthur S. Abramson Department of
The Bronx, New York, United States, 10467