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NCT03480724 · ClinicalTrials.gov registry record · NA
Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Pediatric Patients for Pain Control
A NA study, sponsored by Montefiore Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 55
- Enrollment target
NCT03480724: Clinical Trial NA study, sponsored by Montefiore Medical Center.
NCT03480724 is a NA study that was terminated before completion, run by Montefiore Medical Center. The registered enrollment target is 55 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03480724, a NA study, was terminated before completion, sponsored by Montefiore Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 55 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- OTHER Google Cardboard VRA
- OTHER Oculus Rift VRA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2017-07-06 |
| Est. Completion | 2023-10-27 |
| Phase | NA |
Why NCT03480724 stopped before completion
NCT03480724 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Google Cardboard VRA is the first listed.
NCT03480724 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03480724 about?
NCT03480724 is a clinical study titled "Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Pediatric Patients for Pain Control". 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 Virtu...
What is the current status of trial NCT03480724?
This trial is currently terminated. It is a NA study. The enrollment target is 55 participants. The study started on 2017-07-06. Estimated completion is 2023-10-27.
What interventions are being tested in trial NCT03480724?
The interventions under investigation include: Google Cardboard VRA (OTHER), Oculus Rift VRA (OTHER).
Who is sponsoring clinical trial NCT03480724?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03480724's enrollment target sits among peer trials
55 1264th of 2000 higher than 733 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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