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NCT03619135 · ClinicalTrials.gov registry record · NA
Effectiveness of External Vibration for Pain Relief During Intravenous Access in Adult Patients
A NA study of Anxiety and Pain Management, sponsored by Kyle Stein.
- Completed
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT03619135: Completed NA study of Anxiety and Pain Management, sponsored by Kyle Stein.
NCT03619135 is a NA study of Anxiety and Pain Management that has completed, run by Kyle Stein. The registered enrollment target is 100 participants, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03619135, a NA study of Anxiety and Pain Management, has completed, sponsored by Kyle Stein.
- COMPLETED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Placebo
- DEVICE Buzzy
Study Locations (1)
Iowa
- University of Iowa College of Dentistry - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2016-10-17 |
| Est. Completion | 2017-08-24 |
| Phase | NA |
What the finished NCT03619135 record still lists
NCT03619135 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (77% lower).
The record links to 2 conditions, with Anxiety appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03619135 reports a single indexed study location in Iowa.
Frequently Asked Questions
What is clinical trial NCT03619135 about?
NCT03619135 is a clinical study titled "Effectiveness of External Vibration for Pain Relief During Intravenous Access in Adult Patients". 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 ...
What is the current status of trial NCT03619135?
This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2016-10-17. Estimated completion is 2017-08-24.
What conditions does trial NCT03619135 study?
This clinical trial studies the following conditions: Anxiety, Pain Management.
What interventions are being tested in trial NCT03619135?
The interventions under investigation include: Placebo (OTHER), Buzzy (DEVICE).
Who is sponsoring clinical trial NCT03619135?
This trial is sponsored by Kyle Stein, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03619135 being conducted?
This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03619135's enrollment target sits among peer trials
100 162nd of 364 higher than 188 of 364 other Anxiety trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anxiety trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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