Effectiveness of External Vibration for Pain Relief During Intravenous Access in Adult Patients
NCT ID: NCT03619135
Last Updated: 2019-02-05
Study Results
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View full resultsBasic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2016-10-17
2017-08-24
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Use of Buzzy Device
The Buzzy device was used for IV access for this arm.
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.
Control
No Buzzy device was used - standard IV access for this arm.
Placebo
No use of the Buzzy (standard IV access techniques)
Interventions
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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
No use of the Buzzy (standard IV access techniques)
Eligibility Criteria
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Inclusion Criteria
* Eligible for third molar removal with sedation.
Exclusion Criteria
* Not eligible for sedation.
18 Years
40 Years
ALL
Yes
Sponsors
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Kyle Stein
OTHER
Responsible Party
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Kyle Stein
Principal Investigator
Principal Investigators
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Kyle M Stein, DDS, FACS
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Locations
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University of Iowa College of Dentistry
Iowa City, Iowa, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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201601806
Identifier Type: -
Identifier Source: org_study_id
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