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NCT Number: NCT07520851

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

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.

Recruiting

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Key information

Conditions

Elbow Fractures Arm Injuries Elbow Injuries Fractures, Bone Wounds and Injuries

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OU Health, Oklahoma City, Oklahoma, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flash Cards

Other

1 Flash cards for distraction

Buzzy Ice pack

Device

1 Buzzy system with Flash Cards

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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:

    • 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

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher McCormick, BA

CONTACT

[email protected]

405-271-3480 ext. 34260

Kathy Edge, CRC

CONTACT

[email protected]

405-271-4426 ext. 47988

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 9, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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