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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Use of Buzzy Device | Experimental | The Buzzy device was used for IV access for this arm. |
|
| Control | Placebo Comparator | No Buzzy device was used - standard IV access for this arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyle M Stein, DDS, FACS | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa College of Dentistry | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24912740 | Background | 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. | |
| 22895207 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control | No Buzzy device was used - standard IV access for this arm. Placebo: No use of the Buzzy (standard IV access techniques) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and after IV access |
|
The entirety of the study for each patient. This was approximately 5 minutes for the IV access (portion involving the research) and approximately 60 minutes for the total surgical procedure.
No adverse events were encountered.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kyle Stein | University of Iowa College of Dentistry | 319-384-5105 | kyle-stein@uiowa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 23, 2018 | Jan 17, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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|
| Placebo | Other | No use of the Buzzy (standard IV access techniques) |
|
| 22134226 | 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. |
| BG001 | Control | No Buzzy device was used - standard IV access for this arm. Placebo: No use of the Buzzy (standard IV access techniques) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Control |
No Buzzy device was used - standard IV access for this arm. Placebo: No use of the Buzzy (standard IV access techniques) |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and after IV access |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Control | No Buzzy device was used - standard IV access for this arm. Placebo: No use of the Buzzy (standard IV access techniques) | 0 | 50 | 0 | 50 | 0 | 50 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |