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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-06

Study Completion Date

2023-10-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

3 groups of patients One group with no VR One group with Oculus rift VR One group with google cardboard box VR

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Google Cardboard VRA

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

Group Type ACTIVE_COMPARATOR

Google Cardboard VRA

Intervention Type OTHER

Intervention was randomized and shuffled.

Oculus Rift VRA

This group of subjects will receive VRA with Oculus Rift

Group Type ACTIVE_COMPARATOR

Oculus Rift VRA

Intervention Type OTHER

Intervention was randomized and shuffled.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Google Cardboard VRA

Intervention was randomized and shuffled.

Intervention Type OTHER

Oculus Rift VRA

Intervention was randomized and shuffled.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No