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Buzzy and TickleFlex in Reducing Insulin Injection Pain and Fear
Sponsor: Hakkari Universitesi
Summary
This interventional randomized controlled clinical trial aims to evaluate the effectiveness of two nonpharmacological devices, Buzzy and TickleFlex, in reducing pain and fear associated with insulin injections among children with Type 1 Diabetes Mellitus (T1DM). A total of 90 participants aged 6 to 12 years will be randomly assigned to one of three groups: Buzzy, TickleFlex, or control. The Buzzy device provides combined cold and vibration stimulation near the injection site to decrease pain perception based on the gate control theory, while the TickleFlex device is a soft, flexible attachment for insulin pens designed to minimize needle pressure and discomfort during injection. Pain and fear will be assessed immediately before and after a single insulin injection using validated instruments, including the Wong-Baker FACES Pain Rating Scale and the Children's Fear Scale (CFS), rated independently by the child, parent, and researcher. It is hypothesized that both Buzzy and TickleFlex applications will significantly reduce pain and fear compared to standard insulin injection without intervention. The study is expected to provide evidence supporting the use of nonpharmacological methods in pediatric diabetes care to improve children's comfort and treatment adherence.
Official title: Effectiveness of Buzzy and TickleFlex Applications in Reducing Pain and Fear Associated With Insulin Injections in Children With Type 1 Diabetes
Key Details
Gender
All
Age Range
6 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2025-06-06
Completion Date
2025-12-15
Last Updated
2025-11-20
Healthy Volunteers
Yes
Conditions
Interventions
Buzzy
The Buzzy device is a non-invasive, bee-shaped device that combines cold and vibration to reduce pain perception during needle procedures. It was applied for 30 seconds before and during insulin administration to reduce pain and fear according to the gate control theory.
TickleFlex
The TickleFlex device is a soft, flexible insulin-pen attachment that gently stretches the skin and diffuses needle pressure, reducing injection pain and anxiety in children with Type 1 Diabetes Mellitus.
None (Routine Care)
Standard subcutaneous insulin injection performed following pediatric diabetes nursing protocols.
Locations (1)
Hakkari University
Hakkâri, Centre, Turkey (Türkiye)