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Buzzy and TickleFlex in Reducing Insulin Injection Pain and Fear

NCT07239700 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-11-20

No results posted yet for this 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.

Conditions

  • Diabete Type 1
  • Diabetes in Children

Interventions

DEVICE

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.

DEVICE

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.

OTHER

None (Routine Care)

Standard subcutaneous insulin injection performed following pediatric diabetes nursing protocols.

Sponsors & Collaborators

  • Hakkari Universitesi

    lead OTHER

Principal Investigators

  • Nesrullah AYŞİN, PHD · Hakkari University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-06
Primary Completion
2025-08-06
Completion
2025-12-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07239700 on ClinicalTrials.gov