RECRUITING

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

Description

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.

Conditions

Healthy
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Related Conditions:

Healthy

Study Overview

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Study Details

Study overview

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.

Prospective, Crossover, Open Label Study to Evaluate the Effects of Vibration Anesthesia With DigiVibe on Pain in Subjects Undergoing Intramuscular Injections, Subcutaneous Injections, and Fingersticks (VIB-DIGI)

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

Condition
Healthy
Intervention / Treatment

-

Contacts and Locations

Doral

Universal Axon Clinical Research, LLC, Doral, Florida, United States, 33166

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

East Coast Institute for Research,

Study Record Dates

2025-08-30