An interventional study of Buzzy and Placebo in Pain Management and Anxiety, sponsored by Kyle Stein. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-05.
Sponsored by Kyle Stein · Not applicable, Interventional, and Treatment
A large number of dentoalveolar (tooth extraction) procedures performed by Oral and Maxillofacial Surgeons utilize intravenous sedation. Procedures commonly performed may include surgical removal of teeth, bone grafting, surgical placement of dental implants, and removal of cysts or tumors from the jaws, among others. Obtaining peripheral intravevenous (IV) cannulation often proves to be a very stressful and anxious event for the patient. The anxiety and stress from the venipuncture alone affects not only the psychological stability of the patient, but also the patient's physiology. The Buzzy vibration external stimulation device has shown to be an effective tool in pediatric venipunture procedures. The aim of this study is to investigate the effects of the Buzzy stimulation device in pain and anxiety reduction during peripheral intravenous cannulation in an adult population.
Enrollees in this study will be patients who will undergo dental surgery with intravenous sedation. The patients who are enrolled will receive an IV either with or without the Buzzy. The Buzzy is a small vibration device which will be placed next to the IV placement site.
The participants will be randomized into two groups, those who use the Buzzy system (experimental), and routine IV start (control). Prior to knowing their group, all patients will answer the "Before Intravenous Catheterization" portion of the form in order to eliminate bias. After this portion is complete, their group (experimental vs control) will be determined from opening a blinded envelope.
A tourniquet will be placed, followed by the Buzzy stimulation device (if in the experimental group). An alcohol swab will be used and then a 22 gauge IV catheter will be inserted, connected to fluids, and secured with tape. The antecubital fossa or the dorsal hand/wrist will be the only sites used in the study. All participants will fill out the post-insertion questions on the form and those patients that used the Buzzy system will then fill out the several specific questions related to the experimental group. This will conclude the patient's involvement in the study. The patient will then continue with treatment as planned. We will plan to exclude cases where the IV is not obtained on the first attempt, if a smaller or larger gauge IV catheter is required, or if an insertion site not listed above is required. The case will be excluded if adjunctive steps are taken to obtain IV access (i.e. Oral sedation, nitrous oxide, heat packs).
This is the only study on the registry with Kyle Stein as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The Buzzy device was used for IV access for this arm.
Device: Buzzy
No Buzzy device was used - standard IV access for this arm.
Other: Placebo
The Buzzy is a reusable device that applies vibration to the skin surface to override the body's gate control pain pathway. It has been used effectively to reduce the discomfort of intravenous cannulation (IV placement) in pediatric patients. Also, it has been utilized to reduce the discomfort of injections in pediatric and adult patients. We are preforming this study to evaluate the effectiveness of the Buzzy in reducing the discomfort associated with intravenous cannluation (IV placement) in adults.
No use of the Buzzy (standard IV access techniques)
Change in Pain
Pain is measured on a 10 point visual analog scale with 0 being no pain and 10 being the worst pain imaginable. A higher score is a worse outcome.
Time frame: Baseline and after IV access
Change in Anxiety
Anxiety is measured on a 10 point visual analog scale with 0 being no anxiety and 10 being the worst anxiety imaginable. A higher score is a worse outcome.
Time frame: Baseline and after IV access
| Milestone | Use of Buzzy Device | Control |
|---|---|---|
| Started | 50 | 50 |
| Completed | 50 | 50 |
| Not completed | 0 | 0 |
Pain is measured on a 10 point visual analog scale with 0 being no pain and 10 being the worst pain imaginable. A higher score is a worse outcome.
| score on a scale | Use of Buzzy Device | Control |
|---|---|---|
| Change in Pain | 1.55 ± 1.119 | 1.76 ± 1.401 |
Anxiety is measured on a 10 point visual analog scale with 0 being no anxiety and 10 being the worst anxiety imaginable. A higher score is a worse outcome.
| score on a scale | Use of Buzzy Device | Control |
|---|---|---|
| Change in Anxiety | 1.70 ± 1.743 | 1.84 ± 1.796 |
Collected over The entirety of the study for each patient. This was approximately 5 minutes for the IV access (portion involving the research) and approximately 60 minutes for the total surgical procedure.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Use of Buzzy Device | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Control | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Age, Categorical(Participants) | Use of Buzzy Device | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 50 | 50 | 100 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Use of Buzzy Device | Control | Total |
|---|---|---|---|
| Female | 29 | 26 | 55 |
| Male | 21 | 24 | 45 |
| Race and Ethnicity Not Collected(Participants) | Use of Buzzy Device | Control | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Use of Buzzy Device | Control | Total |
|---|---|---|---|
| United States | 50 | 50 | 100 |
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Plan to share: No
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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