跳至主要内容
临床试验/NCT03619135
NCT03619135已完成不适用

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

Kyle Stein2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年10月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Change in Pain

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Use of Buzzy Device

Experimental

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

干预措施: Buzzy (Device)

Control

Placebo Comparator

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

干预措施: Placebo (Other)

结局指标

主要结局

Change in Pain

时间窗: 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.

Change in Anxiety

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Kyle Stein
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kyle Stein

Principal Investigator

University of Iowa

研究点 (2)

Loading locations...

相似试验