On October 5, 2025, Sakarya University announced a new clinical trial evaluating two innovative approaches to reduce pain, fear, and anxiety during medical procedures for preschool-aged children. The study, accessible via ClinicalTrials.gov, will investigate the Helfer skin tap technique and the ShotBlocker device. Both methods aim to improve the experience of pediatric patients during injections or other potentially distressing interventions.
In this article
What changed?
The clinical trial, set to be conducted by Sakarya University, is among the latest efforts to explore non-pharmacological methods for managing procedural pain in children. Though the study is not yet recruiting participants, its premise highlights the increasing interest in comfort-focused technologies for pediatric healthcare. This trial focuses on preschool-aged children, an especially vulnerable group during medical procedures, as their developmental stage often amplifies fear and anxiety toward injections.
How does each device work?
Helfer skin tap technique
The Helfer skin tap method involves a rhythmic tapping of the skin near the injection site. Designed to stimulate sensory nerves, this technique aims to distract the brain from perceiving the pain of a needle prick. By engaging other nerve receptors, it may reduce overall discomfort during the procedure.
ShotBlocker device
The ShotBlocker is a plastic device that combines pressure and sensory stimulation through its multiple points applied around the injection site. When positioned properly, the device delivers physical distraction, making the pain from the needle less noticeable. ShotBlocker has gained attention as an affordable and easily deployable tool in clinical settings.
What are the expected outcomes?
The primary objective of the trial is to evaluate whether these methods effectively reduce measurable pain, fear, and anxiety levels in preschool-aged children undergoing medical interventions. Secondary outcomes may include improvements in procedural compliance, as reduced distress could lead to calmer patients.
These non-invasive approaches could provide practitioners with new options to improve patient experiences, increasing trust toward medical professionals and enhancing the overall quality of pediatric care.
Frequently Asked Questions
1. Who sponsors this study?
Sakarya University sponsors the trial.
2. What is ShotBlocker?
ShotBlocker is a plastic medical device used to minimize pain and discomfort during injections.
3. Is recruitment open for participants?
As of the publication date, the study is not yet recruiting participants.
4. How can I learn more?
Visit the ClinicalTrials.gov link at the end of this article.
Conclusion
Sakarya University’s clinical trial represents a forward-looking effort to advance pediatric pain management using novel, device-based methods. Healthcare professionals and researchers can follow progress to assess the broader applicability of Helfer skin tap and ShotBlocker in clinical environments. Stakeholders in regulatory teams may also find the trial relevant for developing guidance on child-friendly medical devices.
Disclaimer
This article is for informational purposes only and does not constitute legal, clinical, or regulatory advice. Readers should consult appropriate professionals for specific guidance.
Announcement link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07190547?term=medical+device