NCT03480724

Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Pediatric Patients for Pain Control

Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Pediatric Patients for Pain Control During Botox Injections for Spasticity Management: A Randomized Control Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

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 groups; one group of subjects will randomly be assigned to VRA intervention using Google Cardboard Virtual reality head- mounted display powered by a iPod touch, a second group of subjects will receive VRA with Oculus Rift, and a third group of subjects will receive no intervention beyond standard sedation, anesthetic, and/or restraint-this group will serve as the control group.

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 360 degree video of their choice. Measurements in pain and anxiety will be taken per the outcome measures listed above. Group 2: Google Cardboard VRHMD This group will receive BTI's per conventional protocols. They will wear the Google cardboard VRHMD (Figure 3) powered by iPod touch/smartphone (Figure 4) during the procedure viewing a VR 360 degree video of their choice. Measurements in pain and anxiety will be taken per the outcome measures listed above. Group 3. Control This group will receive BTI's per conventional protocols without VRA intervention.

Conditions

• Pain

Interventions

Type	Name	Description
OTHER	Google Cardboard VRA	Intervention was randomized and shuffled.
OTHER	Oculus Rift VRA	Intervention was randomized and shuffled.

Timeline

• Start date: 2017-07-06
• Primary completion: 2023-10-27
• Completion: 2023-10-27
• First posted: 2018-03-29
• Last updated: 2024-01-05

Locations

1 site across 1 country: United States