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

Completed · Not applicable

Conditions studied: Healthy

In brief

This is a single-center, unblinded, prospective, cross-over study. The study population will include twenty (n=20) healthy subjects (10 men and 10 women) over the age of 18 with a self-reported fear/dislike of needles. Subjects who qualify for the study based on the study inclusion and exclusion criteria and who consent to participate in the study will undergo two (2) intramuscular (IM) injections in the deltoid muscle, two (2) subcutaneous (SC) injections in the abdomen, and two (2) fingersticks with a lancing device in the middle finger. One injection in each location will be performed using with no intervention (as per standard of care) and the other injection in each location will be performed using the DigiVibe device.

Key facts

Study ID

NCT06987201

Run by

East Coast Institute for Research

People needed

20

Starts

2025-08-04

Expected to finish

2025-08-15

Last updated by the study team

2026-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age ≥ 18 years
• BMI 18.5-29.9 kg/m2 (normal)
• Self-reported fear/dislike of needles

You may not qualify if…

• 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
• 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
• Any condition in the opinion of the study investigator that would potentially confound the results of this study

Where it is running

• Universal Axon Clinical Research, LLC — Doral, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.