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Virtual Reality Distraction During Outpatient Pediatric Orthopedic Procedures
NCT05510232 · View on ClinicalTrials.gov ↗
Study Summary
Virtual Reality(VR) has had promising applications in science and medicine, including intervention delivery. The use of VR interventions has been studied in a wide range of medical conditions, including anxiety, phobias, obesity, chronic pain, and eating disorders. VR based simulation in pediatrics has grown rapidly in recent years and is expected to continue to grow. VR technology has become increasingly affordable, flexible, and portable, enabling its use in a broad range of environments including the outpatient clinical setting. Additionally, children are believed to have an inclination toward games of "pretend" or alternate realities further indicating the potential of this technology. While immersed in a game, they often become deeply absorbed and able to ignore aversive stimuli. VR is an engaging intervention that may help to detract from pain and anxiety for children undergoing painful procedures. Heart rate has been used as a means to objectively quantify the physiologic response to pain and anxiety. The purpose of the study is to conduct a randomized controlled study that assess the utility of Virtual Reality simulations compared to non immersive visual distraction in pediatric patients undergoing outpatient procedures including cast removal and surgical suture/pins removal. Primary outcomes will include changes in patient heart rate (an age-validated surrogate for pain and anxiety) and patient-reported changes in anxiety and pain. Secondary outcomes will include patient/parent-reported satisfaction.
Conditions Studied
Interventions
- DEVICE A treatment group that will watch a non-VR video via an iPad
- DEVICE A treatment group that will have headset on and will watch a non-VR video
- DEVICE A treatment group that will be immersed in the VR game (Bear Blast) via the headset.
Study Locations (1)
New York
- Hospital for Special Surgery — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 226 participants |
| Start Date | 2018-07-25 |
| Est. Completion | 2022-05-19 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05510232
The ClinicalTrials.gov registry entry for NCT05510232 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 226 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hospital for Special Surgery, New York, which has 141 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Fractures, Bone appearing as the primary indexed condition, and to 3 interventions — of which A treatment group that will watch a non-VR video via an iPad is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05510232 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05510232 about?
NCT05510232 is a clinical study titled "Virtual Reality Distraction During Outpatient Pediatric Orthopedic Procedures". Virtual Reality(VR) has had promising applications in science and medicine, including intervention delivery. The use of VR interventions has been studied in a wide range of medical conditions, including anxiety, phobias, obesity, chronic pain, and eating disorders. VR based simulation in pediatrics ...
What is the current status of trial NCT05510232?
This trial is currently completed. It is a NA study. The enrollment target is 226 participants. The study started on 2018-07-25. Estimated completion is 2022-05-19.
What conditions does trial NCT05510232 study?
This clinical trial studies the following conditions: Fractures, Bone, Deformity; Bone. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05510232?
The interventions under investigation include: A treatment group that will watch a non-VR video via an iPad (DEVICE), A treatment group that will have headset on and will watch a non-VR video (DEVICE), A treatment group that will be immersed in the VR game (Bear Blast) via the headset. (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05510232?
This trial is sponsored by Hospital for Special Surgery, New York, which has 141 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05510232 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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