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Clinical Trials in Turkey / NCT07239700
Enrolling by invitation Not applicable

Buzzy and TickleFlex in Reducing Insulin Injection Pain and Fear

NCT07239700 · tracked via the Priya Life Science Turkey tracker
Sponsor
Hakkari Universitesi
Phase
Not applicable
Started
2025-06-06
Last updated
2025-11-20

Condition(s) studied

Diabete Type 1Diabetes in Children

Investigational drug(s) / intervention(s)

BuzzyTickleFlexNone (Routine Care)

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.

Study 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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
12 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Children aged 6 to 12 years. * Diagnosed with Type 1 Diabetes Mellitus (T1DM) for at least 6 months. * Receiving daily subcutaneous insulin injections as part of routine diabetes management. * Able to understand and communicate pain and fear levels using the Wong-Baker -FACES Pain Rating Scale and the Children's Fear Scale. * Accompanied by a parent or legal guardian who can provide informed consent. * Willingness of both the child and parent to participate in the study. * No visual, auditory, or cognitive impairments that would interfere with data collection. Exclusion Criteria: * Presence of neurological, sensory, or cognitive disorders that may affect pain or fear perception. * Peripheral neuropathy or other diabetic complications influencing pain sensation. * Use of analgesics, sedatives, or anxiolytic medications within 24 hours prior to data collection. * Local skin lesions, infections, or allergies at or near the insulin injection site. * History of needle phobia or severe anxiety disorders diagnosed by a healthcare professional. * Concurrent participation in another interventional clinical study. * Refusal or inability of the child or parent/guardian to provide written informed consent.

Primary outcome measure(s)

  • Pain Intensity During Insulin Injection — Immediately before and after a single insulin injection.
    The primary outcome is the level of pain experienced by children during insulin injection, measured using the Wong-Baker FACES Pain Rating Scale (0-10). Assessments are performed independently by the child, parent, and researcher immediately before and after the injection. Higher scores indicate greater pain intensity.

Trial sites (1)

FacilityCityRegionStatus
Hakkari University Hakkari Centre

Other trials for the same condition

Hemoglobin Levels and Resolution Time of Diabetic Ketoacidosis in Pediatric Patients Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07239700 on ClinicalTrials.gov ↗ ← All trials in Turkey