Effects of DigiVibe on Pain in Subjects Undergoing Intramuscular Injections, Subcutaneous Injections, and Fingersticks (VIB-DIGI)

East Coast Institute for Research

Status: Not yet enrolling

Conditions: Healthy

Treatments: Device: DigiVibe Vibration Anesthesia

Study type: Interventional

Funder types: NETWORK; Other

Identifiers

NCT06987201

UACR-DIGI-01

Details and patient eligibility

About

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.

Full description

While the complete mechanisms of pain and pain diversion are not completely understood, DigiVibe locally targets the skin's pain receptors. Therefore, it is proposed that the vibrations from the DigiVibe device will counteract and/or lessen the pain around the injection site. This study will determine whether the use of DigiVibe during a procedure requiring injections provides greater reduction in pain than injections with no intervention (standard of care). This information will aid healthcare providers in selecting the best approach to management of pain in patients who must undergo injections that could cause pain and may benefit from additional pain reduction.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

No DigiVibe

No Intervention group

Description:

Standard of Care

DigiVibe

Experimental group

Description:

DigiVibe Vibration Anesthesia

Treatment:

Device: DigiVibe Vibration Anesthesia