Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Pediatric Patients for Pain Control
Purpose
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.
Condition
- Pain
Eligibility
- Eligible Ages
- Between 5 Years and 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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 Criteria
- 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- 3 groups of patients One group with no VR One group with Oculus rift VR One group with google cardboard box VR
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
- Masking Description
- The outcome accessor will have no patient contact and will not have access to the information on the type of intervention study patients were given.
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Active Comparator Google Cardboard VRA |
This group of subjects will receive VRA intervention using Google Cardboard Virtual reality head- mounted display powered by a iPod touch. |
|
Active Comparator Oculus Rift VRA |
This group of subjects will receive VRA with Oculus Rift |
|
No Intervention Control |
This group of subjects will receive no intervention beyond standard sedation, anesthetic, and/or restraint-this group will serve as the control group |
|
More Details
- Status
- Terminated
- Sponsor
- Montefiore Medical Center
Study Contact
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.