N/A
N=100
Effectiveness of External Vibration for Pain Relief During Intravenous Access in Adult Patients
Pain Management · Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT03619135 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Change in Pain — 1.55; 1.76 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Buzzy (Device); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kyle Stein
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain |
1.55; 1.76 | — |
| PRIMARY Change in Anxiety |
1.70; 1.84 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Ages 18 and 40.
- Eligible for third molar removal with sedation.
Exclusion Criteria
- Not eligible for surgery.
- Not eligible for sedation.
Data sourced from ClinicalTrials.gov (NCT03619135). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.