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

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 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.

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

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Other: Google Cardboard VRA
* Other: Oculus Rift VRA


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3 groups of patients One group with no VR One group with Oculus rift VR One group with google cardboard box VR
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Google Cardboard VRA<br>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<br>* Intervention was randomized and shuffled.<br>|
| Active Comparator: Oculus Rift VRA<br>This group of subjects will receive VRA with Oculus Rift | Other: Oculus Rift VRA<br>* Intervention was randomized and shuffled.<br>|
| No Intervention: Control<br>This group of subjects will receive no intervention beyond standard sedation, anesthetic, and/or restraint-this group will serve as the control group | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Pain Measurement | 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. | About 20 minutes per patient. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of severity of anxiety | Measurement of anxiety using Short State-Trait Anxiety Inventory (STAI) Anxiety scale which is a self-evaluation questionnaire completed by the patient's parent or guardian about how they feel and how the child feels at that moment. It consists of 6 questions each having scale 1-4. 1 being Not at all and 4 being Very much. The questions are as follows: I feel calm I am tense I feel upset I am relaxed I feel content I am worried | About 20 minutes per patient |