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Despite efforts no additional participants were able to be enrolled since March 2020.
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| Name | Class |
|---|---|
| American Academy of Physical Medicine and Rehabilitation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Google Cardboard VRA | Active Comparator | This group of subjects will receive VRA intervention using Google Cardboard Virtual reality head- mounted display powered by a iPod touch. |
|
| Oculus Rift VRA | Active Comparator | This group of subjects will receive VRA with Oculus Rift |
|
| Control | No Intervention | This group of subjects will receive no intervention beyond standard sedation, anesthetic, and/or restraint-this group will serve as the control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Google Cardboard VRA | Other | Intervention was randomized and shuffled. |
| |
| 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. |
| 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuxi Chen, MD | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| E-MMC - Rehabilitation Medicine, The Arthur S. Abramson Department of | The Bronx | New York | 10467 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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3 groups of patients One group with no VR One group with Oculus rift VR One group with google cardboard box VR
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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.
| Oculus Rift VRA |
| Other |
Intervention was randomized and shuffled. |
|
| About 20 minutes per patient |