Clinical trial NCT03619135: Effectiveness of External Vibration for Pain Relief During Intravenous Access in Adult Patients
Official title: Effectiveness of External Vibration for Pain Relief During Peripheral Intravenous Cannulation in Adult Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Management
Anxiety
Keywords: Pain
Anxiety
intravenous access
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2018-08-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Not eligible for surgery.
* Not eligible for sedation.

Primary outcomes:
measure: Change in Pain
timeFrame: Baseline and after IV access
measure: Change in Anxiety
timeFrame: Baseline and after IV access
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa College of Dentistry
state: Iowa
Study officials:
affiliation: University of Iowa
name: Kyle M Stein, DDS, FACS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.