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

• 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: Kyle Stein
• Information provided by (Responsible Party): Kyle Stein, University of Iowa

Study Description

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).

Study Design

• 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

Arms and Interventions

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)

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, Iowa

University of Iowa College of Dentistry

Iowa City, Iowa, United States, 52242

Sponsors and Collaborators

Kyle Stein

Investigators

• Principal Investigator: Kyle M Stein, DDS, FACS; University of Iowa

  Study Documents (Full-Text)

Documents provided by Kyle Stein, University of Iowa:

Study Protocol and Statistical Analysis Plan  [PDF] August 23, 2018

More Information

Publications:

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.

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.

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.

• Responsible Party: Kyle Stein, Principal Investigator, University of Iowa
• ClinicalTrials.gov Identifier: NCT03619135
• Other Study ID Numbers: 201601806
• First Posted: August 7, 2018
• 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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Kyle Stein, University of Iowa:

Pain; Anxiety; intravenous access