Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Pediatric Patients for Pain Control During Botox Injections for Spasticity Management: A Randomized Control Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Montefiore Medical Center
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Severity of Pain Measurement
Study Overview
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 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
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- 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.
Eligibility Criteria
- Ages
- 5 Years to 18 Years (Child, Adult)
- Sex
- 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.
Arms & Interventions
Google Cardboard VRA
This group of subjects will receive VRA intervention using Google Cardboard Virtual reality head- mounted display powered by a iPod touch.
Intervention: Google Cardboard VRA (Other)
Oculus Rift VRA
This group of subjects will receive VRA with Oculus Rift
Intervention: Oculus Rift VRA (Other)
Control
This group of subjects will receive no intervention beyond standard sedation, anesthetic, and/or restraint-this group will serve as the control group
Outcomes
Primary Outcomes
Severity of Pain Measurement
Time Frame: About 20 minutes per patient.
Measurement of pain using the Face Legs Activity Cry Consolability scale (FLACC scale) which is a Behavioral Pain Assessment Scale. Each category is scored on the 0-2 scale, that results in total score of 0-10. 0= Relaxed and comfortable , 1-3 = Mild discomfort, 4-6=Moderate pain, 7-10= Severe discomfort or pain or both. Lower score is a good outcome and higher score is a bad outcome. The assessment is for all the subjects in the study.
Secondary Outcomes
- Measurement of severity of anxiety(About 20 minutes per patient)