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

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

ArmDescriptionAssigned 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.
  • Other: Google Cardboard VRA
    Intervention was randomized and shuffled.
Active Comparator
Oculus Rift VRA
This group of subjects will receive VRA with Oculus Rift
  • Other: Oculus Rift VRA
    Intervention was randomized and shuffled.
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

Recruiting Locations

E-MMC - Rehabilitation Medicine, The Arthur S. Abramson Department of
Bronx, New York 10467
Contact:
Yuxi Chen, M.D
718-920-2283
yuchen@montefiore.org

More Details

NCT ID
NCT03480724
Status
Recruiting
Sponsor
Montefiore Medical Center

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.