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Effectiveness of External Vibration for Pain Relief During Intravenous Access in Adult Patients

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ClinicalTrials.gov Identifier: NCT03619135
Recruitment Status : Completed
First Posted : August 7, 2018
Results First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Kyle Stein, University of Iowa

Brief 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.


Condition or disease Intervention/treatment Phase
Pain Management Anxiety Device: Buzzy Other: Placebo Not Applicable

Detailed Description:

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of External Vibration for Pain Relief During Peripheral Intravenous Cannulation in Adult Patients
Actual Study Start Date : October 17, 2016
Actual Primary Completion Date : August 24, 2017
Actual Study Completion Date : August 24, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Use of Buzzy Device
The Buzzy device was used for IV access for this arm.
Device: Buzzy
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.

Placebo Comparator: Control
No Buzzy device was used - standard IV access for this arm.
Other: Placebo
No use of the Buzzy (standard IV access techniques)




Primary Outcome Measures :
  1. Change in Pain [ Time Frame: Baseline and after IV access ]
    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.

  2. Change in Anxiety [ Time Frame: Baseline and after IV access ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ages 18 and 40.
  • Eligible for third molar removal with sedation.

Exclusion Criteria:

  • Not eligible for surgery.
  • Not eligible for sedation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03619135


Locations
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United States, Iowa
University of Iowa College of Dentistry
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Kyle Stein
Investigators
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Principal Investigator: Kyle M Stein, DDS, FACS University of Iowa
  Study Documents (Full-Text)

Documents provided by Kyle Stein, University of Iowa:

Publications:
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Responsible Party: Kyle Stein, Principal Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT03619135     History of Changes
Other Study ID Numbers: 201601806
First Posted: August 7, 2018    Key Record Dates
Results First Posted: February 5, 2019
Last Update Posted: February 5, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Kyle Stein, University of Iowa:
Pain
Anxiety
intravenous access