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

NCT03619135 | Completed Results FDA Device

• 1 other identifier: 201601806
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Management; Anxiety

Keywords

Pain; Anxiety; intravenous access

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and after IV access

Study Arms (2)

Use of Buzzy Device

EXPERIMENTAL

The Buzzy device was used for IV access for this arm.

Device: Buzzy

Control

PLACEBO COMPARATOR

No Buzzy device was used - standard IV access for this arm.

Other: Placebo

Interventions

Buzzy DEVICE

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.

Use of Buzzy Device

Placebo OTHER

No use of the Buzzy (standard IV access techniques)

Control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kyle Stein: lead

Study Sites (1)

University of Iowa College of Dentistry

Iowa City, Iowa, 52242, United States

Location

Related Publications (3)

• Canbulat N, Ayhan F, Inal S. Effectiveness of external cold and vibration for procedural pain relief during peripheral intravenous cannulation in pediatric patients. Pain Manag Nurs. 2015 Feb;16(1):33-9. doi: 10.1016/j.pmn.2014.03.003. Epub 2014 Jun 7.

  PMID: 24912740 BACKGROUND

• Inal S, Kelleci M. Relief of pain during blood specimen collection in pediatric patients. MCN Am J Matern Child Nurs. 2012 Sep;37(5):339-45. doi: 10.1097/NMC.0b013e31825a8aa5.

  PMID: 22895207 BACKGROUND

• Baxter AL, Cohen LL, McElvery HL, Lawson ML, von Baeyer CL. An integration of vibration and cold relieves venipuncture pain in a pediatric emergency department. Pediatr Emerg Care. 2011 Dec;27(12):1151-6. doi: 10.1097/PEC.0b013e318237ace4.

  PMID: 22134226 BACKGROUND

MeSH Terms

Conditions

Agnosia; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Results Point of Contact

• Title: Dr. Kyle Stein
• Organization: University of Iowa College of Dentistry

kyle-stein@uiowa.edu

319-384-5105

Study Officials

• Kyle M Stein, DDS, FACS

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 7, 2018
• Study Start: October 17, 2016
• Primary Completion: August 24, 2017
• Study Completion: August 24, 2017
• Last Updated: February 5, 2019
• Results First Posted: February 5, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)