DigiVibe for Pain During Injections and Fingersticks

(VIB-DIGI Trial)

Overseen By Rebecca F Goldfaden, PharmD, CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: East Coast Institute for Research

Must not be taking: NSAIDs, Antiplatelets, Anticoagulants, Analgesics

Disqualifiers: Chronic pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the DigiVibe device can reduce pain during injections and fingersticks. DigiVibe uses vibration to numb the area, and researchers aim to determine if it makes the experience more comfortable compared to no intervention. The trial includes various types of injections and fingersticks, both with and without the DigiVibe. It seeks participants over 18 who report a fear or dislike of needles. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance comfort during medical procedures.

Will I have to stop taking my current medications?

If you take certain medications daily, like NSAIDs, antiplatelet, anticoagulant, or analgesic drugs, you may not be eligible for the trial. However, if you use these medications occasionally, you should not take them within 3 days before the study starts.

What prior data suggests that the DigiVibe device is safe for reducing pain during injections and fingersticks?

Research has shown that the DigiVibe device can reduce injection pain. Some studies have found that vibration devices like DigiVibe lessen pain during injections. For instance, one study found that people experienced less pain when using a vibration device during injections. Another study showed that these devices also increased satisfaction with the injection experience.

So far, no reports of serious side effects have emerged from using DigiVibe. Since it provides only gentle vibrations, most people tolerate it well. The main goal is to reduce pain, a positive result demonstrated in past research.

Overall, evidence suggests that DigiVibe is safe and may make injections more comfortable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about DigiVibe Vibration Anesthesia because it offers a unique approach to reducing pain during injections and fingersticks. Unlike traditional methods that might use numbing creams or ice packs, DigiVibe uses vibration therapy to distract the nervous system, potentially reducing the sensation of pain. This method is non-invasive and could provide immediate relief without the need for additional medications, making it a promising alternative for those who experience anxiety or discomfort during these common medical procedures.

What evidence suggests that the DigiVibe device is effective for reducing pain during injections and fingersticks?

Studies have shown that vibratory anesthesia, such as the DigiVibe device, can reduce pain during injections. In this trial, some participants will use the DigiVibe device, which research indicates can lessen pain during shots or fingersticks. Initial findings suggest that this method, using vibrations to distract the nervous system, can make needle procedures more comfortable. For those afraid of needles, this could make a significant difference. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for healthy adults over 18 who dislike or fear needles. Participants will receive injections and fingersticks to test if DigiVibe, a vibration anesthesia device, can reduce pain. Those with conditions affecting pain perception or on medications that influence pain sensitivity cannot join.

Inclusion Criteria

BMI 18.5-29.9 kg/m2 (normal)

I am afraid of or dislike needles.

Exclusion Criteria

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

I use pain relief medication every day.

I use NSAIDs, antiplatelet, or anticoagulant medications daily.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo two intramuscular injections, two subcutaneous injections, and two fingersticks, with and without the DigiVibe device

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any immediate adverse effects and pain assessment post-injection

1 day

What Are the Treatments Tested in This Trial?

Interventions

• DigiVibe

Trial Overview The study tests the effectiveness of DigiVibe Vibration Anesthesia in reducing pain from needle procedures. It's a small-scale (20 participants), single-center trial where each person experiences standard injections and those using DigiVibe, allowing direct comparison of their experiences.

How Is the Trial Designed?

Group I: DigiVibe Experimental Treatment 1 Intervention

DigiVibe Vibration Anesthesia

Group II: No DigiVibe Active Control 1 Intervention

Standard of Care

Who Is Running the Clinical Trial?

East Coast Institute for Research

Lead Sponsor

Trials

4

Recruited

340+

Suthe Dermal

Collaborator

Universal Axon Clinical Research, LLC

Collaborator

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06987201

Study Details | NCT06987201 | Effects of DigiVibe on Pain ... This information will aid healthcare providers in selecting the best approach to management of pain in patients who must undergo injections that could cause ...

2. withpower.com withpower.com/trial/digivibe-for-pain-during-injections-and-fingersticks-7f466

DigiVibe for Pain During Injections and Fingersticks (VIB- ... Trial Overview The study tests the effectiveness of DigiVibe Vibration Anesthesia in reducing pain from needle procedures. It's a small-scale (20 participants), ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06987201/effects-of-digivibe-on-pain-in-subjects-undergoing-intramuscular-injections-subcutaneous-injections-and-fingersticks

Effects of DigiVibe on Pain in Subjects Undergoing ... This study will determine whether the use of DigiVibe during a procedure requiring injections provides greater reduction in pain than injections ...

4. app.trialscreen.org app.trialscreen.org/trials/effects-digivibe-on-pain-subjects-undergoing-intramuscular-injections-trial-nct06987201

Effects of DigiVibe on Pain in Subjects Undergoing ... DigiVibe Device Study for Pain Reduction. Evaluating the Effectiveness of the DigiVibe Device in Reducing Pain During Injections and Fingersticks. Check your ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10953530/

Vibratory Anesthesia's Effect on Pain Perception in Upper ... We found that both vapocoolant spray and vibratory anesthesia decreased patient-reported injection pain compared with no intervention.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11587978/

Effectiveness of using a vibration device to ease pain during ... Our study proves that using a vibration device during upper extremity injections can effectively reduce postinjection pain and improve patient satisfaction.

7. trial.medpath.com trial.medpath.com/clinical-trial/46d9811fc0e34779/digivibe-vibration-anesthesia-pain-intramuscular-subcutaneous-injections

Effects of DigiVibe on Pain in Subjects Undergoing ... - MedPath This study will determine whether the use of DigiVibe during a procedure requiring injections provides greater reduction in pain than injections with no ...

8. dentalvibe.com dentalvibe.com/wp-content/uploads/2016/08/turkish-study.pdf

The Effects of Vibration on Pain and Anxiety during Local ... We hypothesized that vibration concurrent with local anesthetic injection would decreased pain and anxiety levels. Therefore, this study evaluated the effects ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8388110/

Differential Analgesia From Vibratory Stimulation During ... Vibratory anesthetic device reduces pain during anesthetic injection, primarily for HN treatments and older male subjects.