Evaluation of An Anxiety Reducing Tool During Thyroid Biopsies: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change in anxiety level of greater than 15% based on Visual Analog Score (VAS)
研究概览
简要总结
Patients undergoing thyroid biopsy under local anesthetic will be asked to fill out a questionnaire that evaluates their anxiety level before and after their procedure. Patients will be randomly assigned to either use an anxiety reducing tool (stress balls in each hand) to take their mind off the procedure or will not receive an anxiety reducing tool.
详细描述
This is a prospective, open-label randomized controlled trial. Given the nature of the intervention, it is not possible to blind participants and the health providers to the treatment group that they are randomized to. The investigators have chosen to conduct a randomized controlled trial as stress balls are not currently a standard offering during IR procedures, and implementing the intervention is relatively simple with minimal to no additional risk to participants in the treatment group. Thyroid biopsies biopsies have been selected as the procedures for this study as these are performed on a regular basis and are conducted solely under local anesthetic without the potentially confounding effect of sedation.
If stress balls are shown to be effective in reducing intraprocedural anxiety, it could become a standard offering for patients undergoing procedures exclusively under local anaesthesia. Use of this tool could also potentially reduce the need for sedation in more complex procedures. Use of a stress ball is a low-cost intervention requiring little investment if the benefit of reducing anxiety and improving patient well-being can be confirmed. Positive results may also open the door to further studies to determine its effectiveness in other anxiety-inducing procedures performed in IR.
The study will take place in the Victoria General Hospital Biopsy Room at the Diagnostic Imaging department of the QEII Health Sciences Centre in Halifax, NS. In the 2023 calendar year, 370 thyroid biopsies were performed at the Centre.
-Research Question and Hypothesis-
Research question: will patients undergoing thyroid biopsies report reduced anxiety if provided with a stress ball compared with those who do not receive one?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects undergoing thyroid biopsies under local anesthetic that can provide consent to treatment and for the research study.
排除标准
- •Previous biopsy experience
- •Greater than one (1) thyroid lesion requiring biopsy
- •Known allergy or sensitivity to stress ball material or cleaning solutions.
研究组 & 干预措施
Stress Balls
Patients given a stress ball in each hand.
干预措施: Stress Balls (Other)
No Stress Balls
Patients NOT given a stress ball in each hand.
结局指标
主要结局
Change in anxiety level of greater than 15% based on Visual Analog Score (VAS)
时间窗: 1 year
The VAS is a simple and easy to administer test, and has been validated for the assessment of self-perceived psychological outcomes such as pain and anxiety. The VAS consists of a continuous 100 mm horizontal rating scale, along which subjects indicate with a tick the point that they feel best represents their state at a specified time, from "not at all anxious" at 0 mm to "extremely anxious" at 100 mm. For each response, a number from 0mm - 100mm will be measured, rounded to the nearest millimeter. In this study, subjects receive a pre-procedure questionnaire and post-procedure questionnaire consisting of VAS questions among other entries.
次要结局
- Changes in stress ball efficacy based on anxiety during "routine" medical procedures, using VAS(1 year)
- Changes in stress ball efficacy based on self-perceived anxiety, using VAS(1 year)
- Changes in stress ball efficacy based on age and sex, using questionnaire questions(1 year)
- Subject self-perceived change in anxiety(1 year)
- Subject opinion on helpful anxiety-reducing methods(1 year)
研究者
Robert Abraham
Professor of Radiology
Nova Scotia Health Authority