Virtual Reality Distraction During Outpatient Pediatric Orthopedic Procedures
Public ClinicalTrials.gov record NCT05510232. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Influence of Virtual Reality Distraction on Pain and Satisfaction During Outpatient Pediatric Orthopedic Procedures: A Randomized Controlled Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05510232
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 226 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 4 Years to 14 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 24, 2018
- Primary completion
- May 18, 2022
- Completion
- May 18, 2022
- Last update posted
- Jan 30, 2025
2018 – 2022
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05510232, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 30, 2025 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05510232 live on ClinicalTrials.gov.