Efficacy of the Buzzy System on Pain and Fear Reduction in Elbow Fracture Pin Removal
1 other identifier
interventional
75
1 country
2
Brief Summary
The goal of this study is to determine if the Buzzy System, a vibrating ice pack shaped like a bee reduces pain in removal of elbow fracture pin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedFirst Posted
Study publicly available on registry
April 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
April 17, 2026
April 1, 2026
1 year
March 27, 2026
April 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Wong Baker Faces
Faces with different emotions ranging from no pain to most pain. Faces are scored from 0 to 10 with higher scores indicating higher levels of pain.
within 10 minutes after procedure
Children's Fear Scale
Faces with different emotions from no anxiety to most anxiety. Faces are scored from 0 to 4 with higher scores indicating higher levels of anxiety.
within 10 minutes after procedure
Secondary Outcomes (1)
Parental Satisfaction Survey
within 10 minutes after procedure
Study Arms (2)
1Buzzy System with Flash Cards
ACTIVE COMPARATOR1 Will use Buzzy System buzzing ice pack and flash cards
2 Flash Cards only
ACTIVE COMPARATOR2 Parental distraction with Flash Cards only
Interventions
Eligibility Criteria
You may qualify if:
- between 3 to 10 years old
- undergoes percutaneous pinning of an elbow fracture
You may not qualify if:
- under age 3 or over age 10
- unable to quantify or express their pain
- Lack of parental consent
- Absence of caregiver during procedure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
OU Health Children's
Oklahoma City, Oklahoma, 73104, United States
OU Health
Oklahoma City, Oklahoma, 73104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kacy Richburg, MD
University of Oklahoma
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Blind Randomization
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2026
First Posted
April 9, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share