Efficacy of the Buzzy System on Pain and Fear Reduction in Elbow Fracture Pin Removal
ConditionElbow Fractures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-10
SponsorUniversity of Oklahoma
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
between 3 to 10 years old
undergoes percutaneous pinning of an elbow fracture
Disqualifiers
under age 3 or over age 10
unable to quantify or express their pain
Lack of parental consent
Absence of caregiver during procedure
Trial design
Design model
Parallel
Treatments tested in this trial
Flash Cards
Other intervention1 Flash cards for distraction
Buzzy Ice pack
Device1 Buzzy system with Flash Cards
Treatment groups
75 Participants
are divided into 2 treatment groupsGroup A: 1Buzzy System with Flash CardsActive comparator 2 interventions
Group B: 2 Flash Cards onlyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
within 10 minutes after procedure2
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.
Time frame
within 10 minutes after procedureSecondary 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: 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
Time frame
within 10 minutes after procedureSponsors and contacts
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Source ClinicalTrials.gov