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.
Brief Title
Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Pediatric Patients for Pain Control
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.
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.
Completion Date
Completion Date Type
Actual
Conditions
Pain
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.
* 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.
Inclusion 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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
18 Years
Minimum Age
5 Years
NCT Id
NCT03480724
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2016-6501
Overall Status
Terminated
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
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.
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.
Outcome Measure
Severity of Pain Measurement
Outcome Time Frame
About 20 minutes per patient.
Secondary Outcomes
Outcome Description
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:
1. I feel calm
2. I am tense
3. I feel upset
4. I am relaxed
5. I feel content
6. I am worried
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:
1. I feel calm
2. I am tense
3. I feel upset
4. I am relaxed
5. I feel content
6. I am worried
Outcome Time Frame
About 20 minutes per patient
Outcome Measure
Measurement of severity of anxiety
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Maximum Age Number (converted to Years and rounded down)
18
Minimum Age Number (converted to Years and rounded down)
5
Investigators
Investigator Type
Principal Investigator
Investigator Name
Yuxi Chen
Investigator Email
yuchen@montefiore.org