NCT07239700Enrolling by invitation
Buzzy and TickleFlex in Reducing Insulin Injection Pain and Fear
Effectiveness of Buzzy and TickleFlex Applications in Reducing Pain and Fear Associated With Insulin Injections in Children With Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 20 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 16 Nov 2025
- Start date
- 6 Jun 2025
- Primary completion date
- 6 Aug 2025
- Lead sponsor
- Hakkari Universitesi
- Diseases
- Type 1 diabetes
- NCT number
- NCT07239700
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 6 Jun 2025 to the primary completion date, 6 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of analgesics, sedatives, or anxiolytic medications within 24 hours prior to data collection.
- Concurrent participation in another interventional clinical study.
Other illness
- Presence of neurological, sensory, or cognitive disorders that may affect pain or fear perception.
- 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.
Other
- Peripheral neuropathy or other diabetic complications influencing pain sensation.
- Refusal or inability of the child or parent/guardian to provide written informed consent.
Who the study is looking for
- 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.
Age in the registry: 6 years to 12 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hakkari University Coordinator of this site? Confirm its status | Hakkari | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.