Efficacy of the Buzzy System on Pain and Fear Reduction in Elbow Fracture Pin Removal

April 13, 2026 updated by: University of Oklahoma
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • OU Health
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • OU Health Children's

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • between 3 to 10 years old
  • undergoes percutaneous pinning of an elbow fracture

Exclusion Criteria:

  • under age 3 or over age 10
  • unable to quantify or express their pain
  • Lack of parental consent
  • Absence of caregiver during procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1Buzzy System with Flash Cards
1 Will use Buzzy System buzzing ice pack and flash cards
Other: Flash Cards
1 Flash cards for distraction
Device: Buzzy Ice pack
1 Buzzy system with Flash Cards
Active Comparator: 2 Flash Cards only
2 Parental distraction with Flash Cards only
Other: Flash Cards
1 Flash cards for distraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within 10 minutes after procedure
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.
within 10 minutes after procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental Satisfaction Survey
Time Frame: within 10 minutes after procedure

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:

  1. My child was comforted by the use of the Distraction Cards and Buzzy system during the procedure
  2. It was a positive Experience
  3. I think the Buzzy System is easy to use
  4. I would like to use the Buzzy System in the future for invasive procedure for my son/daughter

Control Arm:

  1. My child was comforted by the use of the Distraction Cards during the procedure
  2. It was a positive experience
  3. I would like the option to use additional distraction methods like the Buzzy System in the future for invasive procedure for my son/daughter
within 10 minutes after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Investigators

  • Principal Investigator: Kacy Richburg, MD, University of Oklahoma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

March 27, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18347

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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