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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 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.

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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.

Conditions Studied

Anxiety Pain Management

Interventions

  • OTHER Placebo
  • DEVICE Buzzy

Study Locations (1)

Iowa

  • University of Iowa College of Dentistry - Iowa City

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2016-10-17
Est. Completion 2017-08-24
Phase NA

Sponsor

Kyle Stein

1 total trials

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What the Registry Record Tells You About NCT03619135

The ClinicalTrials.gov registry entry for NCT03619135 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (77% lower). The listed sponsor is Kyle Stein, which has 1 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.