An interventional study of Virtual Reality (VR) in Fractures, Bone, sponsored by Gillette Children's Specialty Healthcare. Recruiting at 1 site in United States. Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2021-02-11.
Sponsored by Gillette Children's Specialty Healthcare · Not applicable, Interventional, and Supportive care
Among 192 studies in Fractures, Bone with a site in United States — 37 open to participants now, 43 under way, 2 of them phase 3. Fractures, Bone · United States.
Among the 192 studies in Fractures, Bone with a site in United States, this one is the 36th largest by planned enrollment of the 129 interventional ones that give a count, is one of 13 that started in 2019, is one of 64 with no phase, reaches primary completion later than 0 of the 42 other live ones, and was the 122nd registered.
724 studies on the registry are indexed under Fractures, Bone; 114 are open to participants now.
Browse Fractures, Bone studies →37 of the 192 studies in Fractures, Bone with a site in United States are open now. Recruiting first, the newest first:
Columbia University · Sites in United States
Ages 6–17
Amber Implants B.V. · Sites in United States
Ages 21–85
BoneVue Diagnostics · Sites in United States
Ages 30–90
The Cooper Health System · Sites in United States
Ages 65+
Mayo Clinic · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 70 Fractures, Bone studies recruiting now, 35 (50%) set no upper age limit and 21 (30%) stop at 75 or younger; 17 take children under 18; 14 take healthy volunteers.
This study: 4 Years to 12 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
192 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 27 · Phase 3 21 · Phase 4 19
First in 1991; this study’s year is marked. 13 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 184 is above the median of 80 across 458 interventional studies indexed under Fractures, Bone.
Median enrollment 87 across the 129 interventional studies, 100 across the 63 observational. Of the 134 that completed or were terminated, 54 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
48 of 192 have an industry lead sponsor. The 10 most frequent:
Gillette Children's Specialty Healthcare is the lead sponsor of 18 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Gillette Children's Specialty Healthcare has 1 study filed under Fractures, Bone — fewer than ten, so there is no comparison to draw.
15 of the studies in Fractures, Bone with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05699174Phase 3Major Extremity Trauma Research ConsortiumPO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation | 2027-09 |
| NCT06450639Hoffmann-La RocheA Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD) | 2026-11-18 |
| NCT05824676Hartford HospitalDePuy Synthes Variable Angle LCP Patella Plating System Study | 2026-12 |
| NCT07430345The Cooper Health SystemBuprenorphine for Analgesia in Older Adults With Acute Fractures in the Emergency Department | 2026-12 |
| NCT06256458Artoss Inc.Prospective Registry to Evaluate Outcomes of NanoBone® Bone Graft in Acute Trauma | 2026-12-01 |
Add all 15 to your calendar (.ics) → With an account.
Among the 192 studies in Fractures, Bone with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study is a randomized control trial of Virtual Reality during cast removal procedures at a pediatric tertiary care center.
Cast removal is a common outpatient procedure and is a source of pain and anxiety for children. Children are often frightened by the appearance and the noise of the saw. Additionally, the saw blade can become warm, and this can be uncomfortable. Multiple methods have been used and studied to try to make this experience easier for children. These methods include: soft music, therapeutic play, and headphones. Virtual reality (VR) devices are now increasingly affordable and portable. VR could be a way to distract children from the appearance and sound of the procedure. VR has been used in other clinical settings to help patients with the anxiety associated with medical procedures. The investigators propose a randomized trial to assess the responses (e.g. questionnaires and monitors) of children to cast removal with VR versus the standard noise reduction headphones.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants will experience Virtual Reality during their cast removal
Device: Virtual Reality (VR)
Participants will receive their usual standard of care treatment during cast removal
Participants in the experimental group will receive an AppliedVR virtual reality headset during their cast removal.
Also known as: AppliedVR
Change from baseline heart rate during cast removal procedure
The change from baseline heart rate during cast removal procedure obtained by using an electronic monitoring wristband and measuring heart rate 15 seconds prior to and continuously during the cast removal procedure.
Time frame: Heart rate will be measured during the cast removal procedure. As this is a single visit study, heart rate will not be measured at any other time periods throughout the study.
Change in Parent Reported Wong-Baker FACES Pain Scale Rating
Parent reported pain scale that is rated from 0 (minimum) to 10 (maximum), where a higher number indicates increased pain.
Time frame: The Wong-Baker FACES Pain Scale assessment will be collected 1 minute prior to and immediately after cast removal.This is a single visit study and the assessment will not be measured at any other time periods.
Change in Patient Reported Wong-Baker FACES Pain Scale Rating
Patient reported pain scale that is rated on a scale of 0 (minimum) to 10 (maximum), where a higher number indicates increased pain.
Time frame: The Wong-Baker FACES Pain Scale assessment will be collected 1 minute prior to and immediately after cast removal.This is a single visit study and the assessment will not be measured at any other time periods.
Visual Analog Scale (VAS): Parental anxiety during cast removal
Parental anxiety will be self reported using a 0 (minimum) to 100 (maximum) scale, where a higher number indicates increased anxiety.
Time frame: The VAS anxiety assessment will be performed immediately after the cast removal procedure, which is expected to last 5-10 minutes.This is a single visit study and the assessment will not be measured at any other time periods.
Visual Analog Scale (VAS): Patient anxiety during cast removal
Patient anxiety regarding the cast removal will be self reported using a 0 (minimum) to 100 (maximum) scale, where a higher number indicates increased anxiety.
Time frame: The VAS anxiety assessment will be performed immediately after the cast removal procedure, which is expected to last 5-10 minutes.This is a single visit study and the assessment will not be measured at any other time periods.
Visual Analog Scale (VAS): Parental Satisfaction
Parental satisfaction regarding the cast removal will be self reported using a 0 (minimum) to 100 (maximum) scale, where a higher number indicates increased satisfaction.
Time frame: The VAS parental satisfaction assessment will be performed immediately after the cast removal procedure, which is expected to last 5-10 minutes.This is a single visit study and the assessment will not be measured at any other time periods.
Visual Analog Scale (VAS): Parental Assessment of Pleasantness
Parental report of how pleasant the cast removal was. Self reported using a 0 (minimum) to 100 (maximum) scale, where a higher number indicates increased pleasantness.
Time frame: The VAS parental satisfaction assessment will be performed immediately after the cast removal procedure, which is expected to last 5-10 minutes.This is a single visit study and the assessment will not be measured at any other time periods.
Visual Analog Scale (VAS): Parent Reported Worst Pain During Treatment
Parental report of the highest level of pain experienced by the child during the cast removal. Reported using a 0 (minimum) to 100 (maximum) scale, where a higher number indicates increased pain.
Time frame: The VAS parental worst pain assessment will be performed immediately after the cast removal procedure, which is expected to last 5-10 minutes.This is a single visit study and the assessment will not be measured at any other time periods.
Visual Analog Scale (VAS): Patient Reported Worst Pain During Treatment
Patient report of the highest level of pain experienced by the child during the cast removal. Reported using a 0 (minimum) to 100 (maximum) scale, where a higher number indicates increased pain.
Time frame: The VAS patient worst pain assessment will be performed immediately after the cast removal procedure, which is expected to last 5-10 minutes.This is a single visit study and the assessment will not be measured at any other time periods.
Plan to share: No
Started May 2019 (actual). Primary completion is estimated for Sep 2021, 28 months after the start.
Of 148 non-industry interventional studies with no phase under Fractures, Bone, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 57. This study's planned 28 months is close to that.
Counting every sponsor, half of 166 studies reached it within 29 months; a quarter within 12 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
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Gillette Children's Specialty Healthcare