This report covers a nonpharmacological approach using a ShotBlocker device to reduce pain and fear during breast cancer hormone injections, based on an Inonu University study.
Publication date context February 15, 2026. The study describes a device based intervention intended to accompany gluteal injections for hormone therapy. The protocol combines a ShotBlocker device with rhythmic gentle tapping around the injection site to address injection related discomfort and anxiety. The record notes this is a description of an intervention and does not claim efficacy.
- What is the ShotBlocker approach?
- What regulatory and sponsorship details exist?
- What are the patient implications?
What is the ShotBlocker approach and the tapping technique?
The study from Inonu University centers on a device described as ShotBlocker used during gluteal injections for hormone therapy in breast cancer patients. The intervention is defined as rhythmic, gentle tapping with the fingertips on the skin surrounding the injection site. This nonpharmacologic technique is described as an adjunct to standard injection practice and is not presented as a stand alone therapy in the record. Clinicians should note the description does not provide results or efficacy data in the record.
Proponents suggest that tapping can influence peripheral sensation and attention, potentially reducing perceived pain and anxiety. However the description does not specify device parameters, duration, or patient selection criteria. The lack of results means no practice change can be recommended yet.
What regulatory and sponsorship details exist for this device and trial?
The entry lists Inonu University as the sponsor. The trial status is described as not yet recruiting on ClinicalTrials.gov under identifier NCT07406165. The source text confirms the focus on conditions including breast cancer and pain management and emphasizes an intervention involving a medical device and procedure. No device clearance status, performance data, or safety outcomes are stated in the record. Under MDR style expectations a defined intended use and safety assessment would be required to support market entry, but these elements are not provided here.
The sponsor and status reflect early stage research rather than an immediate path to market clearance. This context helps regulators and clinicians gauge the maturity of the device concept and the reliability of its claims.
What are the patient implications and potential impact?
If validated by results, the approach could offer a nonpharmacologic option to lessen injection related pain and fear for patients undergoing hormone therapy for breast cancer. Benefits could include improved comfort, better willingness to continue treatment, and reduced procedural distress. Until results are published, clinicians should treat this as an exploratory description and await formal study outcomes and regulatory clearance before clinical adoption. The presence of a defined sponsor and a not yet recruiting status suggests this is early stage research rather than an immediately market ready solution.
- Q1. What is being studied? A nonpharmacologic approach using a ShotBlocker device with tapping around the injection site during hormone injections for breast cancer.
- Q2. Who sponsors the study? Inonu University.
- Q3. What is the recruitment status? Not yet recruiting, according to ClinicalTrials.gov entry NCT07406165.
Conclusion
The study describes a nonpharmacologic method to potentially reduce pain and fear during injections, but no outcomes are reported. Observers should await trial results and regulatory clearance before altering practice.
Disclaimer
This article is intended for medical professionals and regulatory teams. It is not legal advice and does not substitute for regulatory consultation. Always refer to official MDR documentation for device clearance and postmarket obligations.
Announcement line
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07406165?term=medical+device