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

Montefiore Medicine Academic Health System

Status: Terminated

Conditions: Pain

Treatments: Other: Google Cardboard VRA; Other: Oculus Rift VRA

Study type: Interventional

Funder types: Other

Identifiers

NCT03480724

2016-6501

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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55 participants in 3 patient groups

Google Cardboard VRA

Active Comparator group

Description:

This group of subjects will receive VRA intervention using Google Cardboard Virtual reality head- mounted display powered by a iPod touch.

Treatment:

Other: Google Cardboard VRA

Oculus Rift VRA

Active Comparator group

Description:

This group of subjects will receive VRA with Oculus Rift

Treatment:

Other: Oculus Rift VRA

Control

No Intervention group

Description:

This group of subjects will receive no intervention beyond standard sedation, anesthetic, and/or restraint-this group will serve as the control group