Elbow FracturesNCT07520851
Efficacy of the Buzzy System on Pain and Fear Reduction in Elbow Fracture Pin Removal
A study testing Flash Cards and Buzzy Ice pack in people with Elbow Fractures, run by University of Oklahoma at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Elbow Fractures
- What is being tested?
- Flash Cards and Buzzy Ice pack
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- between 3 to 10 years old
- undergoes percutaneous pinning of an elbow fracture
Who cannot join
- under age 3 or over age 10
- unable to quantify or express their pain
- Lack of parental consent
- Absence of caregiver during procedure
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
OU Health Children's
Oklahoma City, Oklahoma, 73104
- Recruiting
OU Health
Oklahoma City, Oklahoma, 73104
About this study
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.
Read the detailed description
Perform a randomized single blind control trial in children ages 3 to 10 to determine if the Buzzy System, a vibrating cold application system reduces pain, measured by the Wong-Baker Faces Pain Rating, and also reduce fear associated with the procedure measured through the Children's Fear Scale by the child and parents and the doctor pulling the pins.
- Conditions
- Elbow Fractures
- Being tested
- Flash Cards, Buzzy Ice pack
- Keywords
- Pin Pulling
- Medical subject headings
- Elbow Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flash CardsOther
1 Flash cards for distraction
Buzzy Ice packDevice
1 Buzzy system with Flash Cards
| Study group | Role | What they receive |
|---|---|---|
| 1Buzzy System with Flash Cards | Active comparator | 1 Will use Buzzy System buzzing ice pack and flash cards Receives: Other: Flash Cards; Device: Buzzy Ice pack |
| 2 Flash Cards only | Active comparator | 2 Parental distraction with Flash Cards only Receives: Other: Flash Cards |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: within 10 minutes after procedure
Secondary outcomes (1)
Parental Satisfaction Survey
Parents are asked to rate the following statements on a 1 to 5 Likert Scale with 1 being "No" and 5 being "Definitely".
Experimental Arm:
- My child was comforted by the use of the Distraction Cards and Buzzy system during the procedure
- It was a positive Experience
- I think the Buzzy System is easy to use
- I would like to use the Buzzy System in the future for invasive procedure for my son/daughter
Control Arm:
- My child was comforted by the use of the Distraction Cards during the procedure
- It was a positive experience
- I would like the option to use additional distraction methods like the Buzzy System in the future for invasive procedure for my son/daughter
Measured: within 10 minutes after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study startSep 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elbow FracturesStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a randomized control trial
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kacy Richburg, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520851
- Sponsor's protocol ID
- 18347P
- Status last verified
- Jul 2026
- First submitted
- 27 Mar 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Buzzy System on Pain and Fear Reduction in Elbow Fracture Pin Removal
- ClinicalTrials.gov ID
- NCT07520851
- Acronym / sponsor ID
- 18347P
- Conditions
- Elbow Fractures
- Keywords
- Pin Pulling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Perform a randomized single blind control trial in children ages 3 to 10 to determine if the Buzzy System, a vibrating cold application system reduces pain, measured by the Wong-Baker Faces Pain Rating, and also reduce fear associated with the procedure measured through the Children's Fear Scale by the child and parents and the doctor pulling the pins.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a randomized control trial
| Arm | Type | Receives |
|---|---|---|
| 1Buzzy System with Flash Cards | Active comparator | Other: Flash Cards, Device: Buzzy Ice pack1 Will use Buzzy System buzzing ice pack and flash cards |
| 2 Flash Cards only | Active comparator | Other: Flash Cards2 Parental distraction with Flash Cards only |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- between 3 to 10 years old
- undergoes percutaneous pinning of an elbow fracture
Key exclusion criteria (4 listed)
- under age 3 or over age 10
- unable to quantify or express their pain
- Lack of parental consent
- Absence of caregiver during procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flash Cards1 Flash cards for distraction | Other | 1Buzzy System with Flash Cards, 2 Flash Cards only |
| Buzzy Ice pack1 Buzzy system with Flash Cards | Device | 1Buzzy System with Flash Cards |
Primary outcome
Wong Baker Faces
Time frame: within 10 minutes after procedure
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.
Children's Fear Scale
Time frame: within 10 minutes after procedure
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.
1 secondary outcome
Parental Satisfaction Survey
Time frame: within 10 minutes after procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kacy Richburg, MD principal investigator
University of Oklahoma
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flash Cards and Buzzy Ice pack in people with Elbow Fractures, run by University of Oklahoma at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathy Edge, CRC (405-271-4426 ext. 47988, Kathy-edge@ou.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wong Baker Faces (time frame: within 10 minutes after procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.