Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Pediatric Patients for Pain Control (PEDSPAINVR)
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ClinicalTrials.gov Identifier: NCT03480724 |
Recruitment Status :
Recruiting
First Posted : March 29, 2018
Last Update Posted : December 17, 2019
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Condition or disease | Intervention/treatment | Phase |
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Pain | Other: Google Cardboard VRA Other: Oculus Rift VRA | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 90 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention 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 (Outcomes Assessor) |
Masking Description: | 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. |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | July 6, 2017 |
Estimated Primary Completion Date : | June 2021 |
Estimated Study Completion Date : | December 2021 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Google Cardboard VRA
This group of subjects will receive VRA intervention using Google Cardboard Virtual reality head- mounted display powered by a iPod touch.
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Other: Google Cardboard VRA
Intervention was randomized and shuffled. |
Active Comparator: Oculus Rift VRA
This group of subjects will receive VRA with Oculus Rift
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Other: Oculus Rift VRA
Intervention was randomized and shuffled. |
No Intervention: Control
This 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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- Severity of Pain Measurement [ Time Frame: About 20 minutes per patient. ]
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.
- Measurement of severity of anxiety [ Time Frame: About 20 minutes per patient ]
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

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Ages Eligible for Study: | 5 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480724
United States, New York | |
E-MMC - Rehabilitation Medicine, The Arthur S. Abramson Department of | Recruiting |
Bronx, New York, United States, 10467 | |
Contact: Yuxi Chen, M.D 718-920-2283 yuchen@montefiore.org | |
Contact: Matthew Bartels, M.D,MPH (718) 920-2751 mbartels@montefiore.org | |
Principal Investigator: Yuxi Chen, M.D | |
Sub-Investigator: Erosa Stephen | |
Sub-Investigator: Jared Ruben Levin, MD |
Responsible Party: | Yuxi Chen, Assistant Professor, Montefiore Medical Center |
ClinicalTrials.gov Identifier: | NCT03480724 |
Other Study ID Numbers: |
2016-6501 |
First Posted: | March 29, 2018 Key Record Dates |
Last Update Posted: | December 17, 2019 |
Last Verified: | December 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |