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Completed

NCT Number: NCT03193762

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lille Catholic Hospitals, Lille, Nord, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

anxiety VAS

Other

Anxiety will be measure with a 10-points visual analogic scale (VAS)

Primary outcomes

  1. 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.

Secondary outcomes

  1. Number of patients presenting anxiety.

    Time frame: at inclusion

    Number of patients presenting significant anxiety according to the different scales used.

  2. 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

  3. Concordance between STAI-Ya and HAD-7A scales.

    Time frame: at inclusion

    Correlation between STAI-Ya and HAD-7A scores.

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Collaborators

  • Centre Hospitalier de Roubaix
  • Tourcoing Hospital
  • Wattrelos hospital

Registry information

Acronym: EVANX

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 21, 2017
Registry last updated
Mar 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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