Effects of DigiVibe on Pain in Subjects Undergoing Intramuscular Injections, Subcutaneous Injections, and Fingersticks

Launched by EAST COAST INSTITUTE FOR RESEARCH · May 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a device called DigiVibe to see if it can help reduce pain for people who are afraid of needles during common procedures like injections and fingersticks. The trial will include 20 healthy adults, both men and women, who are at least 18 years old and have a fear or dislike of needles. To qualify, participants must have a body mass index (BMI) between 18.5 and 29.9, which is considered normal weight.

During the study, each participant will receive two types of injections in their arm and abdomen, as well as two fingersticks in their finger. For each procedure, one will be done using standard methods without any help, while the other will use the DigiVibe device. This means that participants will experience both the usual way and the new way of doing these procedures. The trial is not currently recruiting participants, but it's important for those who are considering joining to know that certain medications and health conditions may prevent them from participating.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years
• • 2. BMI 18.5-29.9 kg/m2 (normal)
• • 3. Self-reported fear/dislike of needles
• Exclusion Criteria:
• • 1. Chronic (daily) use of nonsteroidal anti-inflammatory drugs (NSAIDs) (i.e. ibuprofen, aspirin, naproxen, etc.), antiplatelet medications (i.e. clopidogrel, prasugrel, ticagrelor, cangrelor, cilostazol, etc), or anticoagulant medications (i.e. warfarin, dabigatran, rivaroxaban, apixaban, edoxaban, heparin, enoxaparin, fondaparinux, etc.)
• • Note: NSAIDs used as needed are not excluded as long as they are not used within 3 days of study screening and enrollment
• • 2. Chronic (daily) use of analgesics (i.e. acetaminophen, NSAIDs \[ie. ibuprofen, naproxen\], opioids \[ie. morphine, oxycodone, fentanyl\], lidocaine, cannabinoids \[ie. CBD, THC\],)
• • Note: analgesics used as needed are not excluded as long as they are not used within 3 days of study screening and enrollment
• • 3. Any condition in the opinion of the study investigator that would potentially confound the results of this study