Clinical trial NCT03480724: Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Pediatric Patients for Pain Control
Official title: Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Pediatric Patients for Pain Control During Botox Injections for Spasticity Management: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: American Academy of Physical Medicine and Rehabilitation
First posted: 2018-03-29
Enrollment: 55
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Severity of Pain Measurement
timeFrame: About 20 minutes per patient.
Secondary outcomes:
measure: Measurement of severity of anxiety
timeFrame: About 20 minutes per patient
Other outcomes:
Locations:
city: Bronx
country: United States
facility: E-MMC - Rehabilitation Medicine, The Arthur S. Abramson Department of
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Yuxi Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: