Buzzy and TickleFlex in Reducing Insulin Injection Pain and Fear (NCT07239700) | Clinical Trial Compass
By InvitationNot Applicable
Buzzy and TickleFlex in Reducing Insulin Injection Pain and Fear
Turkey (Türkiye)90 participantsStarted 2025-06-06
Plain-language 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.
Who can participate
Age range
6 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain Intensity During Insulin Injection
Timeframe: Immediately before and after a single insulin injection.