跳至主要内容
临床试验/NCT03193762
NCT03193762已完成不适用

Usefulness of a Visual Analogue Scale to Evaluate Anxiety in the Painful Hospitalized Patient

Lille Catholic University4 个研究点 分布在 1 个国家目标入组 406 人开始时间: 2017年8月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
406
试验地点
4
主要终点
Correlation between Anxiety VAS and STAI-Ya and HAD-7A scores

研究概览

简要总结

Today, there is no simple tool for measuring patient anxiety. The primary purpose of this study is to evaluate the ability of the Visual Analogue Scale (VAS) to measure anxiety in painful hospitalized patients, and to correlate it to STAI-Ya and HAD-7A auto questionnaires.

详细描述

Pain is one of the major signs, if not the first, which encourages patient to call caregivers. It is a complex and multidimensional sensorial experience. An optimal pain management should consider these different dimensions. If not, the risk is to misidentify pain causes, resulting in therapeutic failures.

Anxiety is one of these dimensions. It's an emotional factor particularly frequent in hospitalized patient.

Pain and hospitalization are both sources of anxiety. Anxiety causes discomfort, hyper vigilance reactions and pain focusing; it can cause avoidance behavior and non-compliance with prescribed medical treatments. Specific care of anxiety can result in a positive impact on hospitalized patient's pains and comfort.

Screening tools for anxiety exist. The STAI-Y is the actual reference scale to measure anxiety. The "Ya" version measures anxiety linked with the reactional state. It's composed of 20 questions and scores of 45 and higher define a significant anxiety (at least moderate). Another tool, the HAD scale, measures anxiety and depression. It has been validated on a population of hospitalized patients. It's composed of 14 questions including 7 about anxiety (HAD-7A). An 11 and higher score defines a significant anxiety (at least moderate). But these tools, theoretically accessible to caregivers, are not often used, especially in hospitalization. The principal reason is their inadequacy to the real conditions in services. Their utilization is too restrictive to hope for an exhaustive diagnosis in routine clinical practice (e.g. the need to have a specific support at disposal or the time to fill in the auto-questionnaires). It would be particularly pertinent to have a faster and easier tool at disposal.

Studies suggest the usefulness of the Visual Analog Scale (VAS) to measure anxiety in pre-operatory or pre-interventional context. This study aims at evaluating VAS' interest in a very frequent situation, the one of painful hospitalized patient. If the VAS demonstrates its capacity to detect and measure anxiety as the validated scales, its utilization could be proposed at the same time as VAS for pain. When pain is assessed by VAS, it'd be easy and simple to evaluate anxiety with the anxiety-VAS, with the same tool, systematically or in anxiety identified situations. Anxious patients who could have specific treatments for anxiety would be better detected and cared for in a general way in accordance with good practice recommendations.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Aged ≥ 18 years old
  • Patient hospitalized in a medical or chirurgical service.
  • Patient presenting a moderate to acute pain (Pain VAS ≥4)

排除标准

  • Patient unable to fill in the auto questionnaire
  • Refusal, unwillingness of the patient to participate to the study
  • Patients under guardianship, trusteeship and judicial protection

结局指标

主要结局

Correlation between Anxiety VAS and STAI-Ya and HAD-7A scores

时间窗: at inclusion

Correlation between Anxiety-VAS and STAI-Ya, HAD-7A scores.

次要结局

  • Link between anxiety scores and several factors(at inclusion)
  • Number of patients presenting anxiety.(at inclusion)
  • Concordance between STAI-Ya and HAD-7A scales.(at inclusion)

研究者

发起方
Lille Catholic University
申办方类型
Other
责任方
Sponsor

研究点 (4)

Loading locations...

相似试验