RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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)

Quick Facts

Study Start:2025-08-04
Study Completion:2025-08-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06987201

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥ 18 years
  2. 2. BMI 18.5-29.9 kg/m2 (normal)
  3. 3. Self-reported fear/dislike of needles
  1. 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.)
  2. * Note: NSAIDs used as needed are not excluded as long as they are not used within 3 days of study screening and enrollment
  3. 2. Chronic (daily) use of analgesics (i.e. acetaminophen, NSAIDs \[ie. ibuprofen, naproxen\], opioids \[ie. morphine, oxycodone, fentanyl\], lidocaine, cannabinoids \[ie. CBD, THC\],)
  4. * Note: analgesics used as needed are not excluded as long as they are not used within 3 days of study screening and enrollment
  5. 3. Any condition in the opinion of the study investigator that would potentially confound the results of this study

Contacts and Locations

Study Contact

Rebecca F Goldfaden, PharmD, CCRP
CONTACT
(305) 677-9267
rg@roviaclinical.com

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: East Coast Institute for Research

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-04
Study Completion Date2025-08-30

Study Record Updates

Study Start Date2025-08-04
Study Completion Date2025-08-30

Terms related to this study

Keywords Provided by Researchers

  • DigiVibe
  • Vibration Anesthesia

Additional Relevant MeSH Terms

  • Healthy