Usefulness of a Visual Analogue Scale to Evaluate Anxiety in the Painful Hospitalized Patient (EVANX)
|ClinicalTrials.gov Identifier: NCT03193762|
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : March 22, 2019
|Condition or disease||Intervention/treatment|
|Pain Anxiety||Other: Anxiety VAS|
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.
|Study Type :||Observational|
|Actual Enrollment :||406 participants|
|Official Title:||Usefulness of a Visual Analogue Scale to Evaluate Anxiety in the Painful Hospitalized Patient|
|Actual Study Start Date :||August 7, 2017|
|Actual Primary Completion Date :||June 1, 2018|
|Actual Study Completion Date :||September 1, 2018|
Painful hospitalized patient
The anxiety of those patients will be measured with an Anxiety VAS
Other: Anxiety VAS
Anxiety will be measure with a 10-points visual analogic scale (VAS)
- Correlation between Anxiety VAS and STAI-Ya and HAD-7A scores [ Time Frame: at inclusion ]Correlation between Anxiety-VAS and STAI-Ya, HAD-7A scores.
- Number of patients presenting anxiety. [ Time Frame: at inclusion ]Number of patients presenting significant anxiety according to the different scales used.
- Link between anxiety scores and several factors [ Time Frame: at inclusion ]The link between the scores at the different anxiety scales and the following factors will be assessed : age, gender, study level, prior hospitalization, antecedent of anxiety-depressive symptoms, treatment, hospitalisation services, reason for hospitalisation, time between hospitalisation and inclusion, painful care, pain origin and pain history
- Concordance between STAI-Ya and HAD-7A scales. [ Time Frame: at inclusion ]Correlation between STAI-Ya and HAD-7A scores.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193762
|Lille Catholic Hospitals|
|Lille, Nord, France, 59462|
|Roubaix, France, 59100|
|Tourcoing, France, 59200|
|Wattrelos, France, 59150|
|Principal Investigator:||Vincent Ducoulombier, MD||Lille Catholic University|