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NCT05510232 · ClinicalTrials.gov registry record · NA

Virtual Reality Distraction During Outpatient Pediatric Orthopedic Procedures

A NA study of Fractures, Bone and Deformity; Bone, sponsored by Hospital for Special Surgery, New York.

Completed
Registry status
NA
Development phase
226
Enrollment target
1
Study location

NCT05510232 is a NA study of Fractures, Bone and Deformity; Bone that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 226 participants, below the 1,927-participant average among 12 other Fractures, Bone trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05510232, a NA study of Fractures, Bone and Deformity; Bone, has completed, sponsored by Hospital for Special Surgery, New York.

COMPLETED
Registry status
NA
Development phase
226 participants
Enrollment target
1
Study location

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.

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

FieldValue
Enrollment Target 226 participants
Start Date 2018-07-25
Est. Completion 2022-05-19
Phase NA

What the Registry Record Tells You About NCT05510232

The ClinicalTrials.gov registry entry for NCT05510232 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 226 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,927-participant average among 12 other Fractures, Bone trials with a reported enrollment target (88% lower). The listed sponsor is Hospital for Special Surgery, New York, which has 194 total studies on file at ClinicalTrials.gov.

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.

NCT05510232 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

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.

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).

Who is sponsoring clinical trial NCT05510232?

This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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