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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03193762
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : March 22, 2019
Sponsor:
Collaborators:
Centre Hospitalier de Roubaix
Tourcoing Hospital
Wattrelos hospital
Information provided by (Responsible Party):
Lille Catholic University

Brief Summary:
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.

Condition or disease Intervention/treatment
Pain Anxiety Other: Anxiety VAS

Detailed Description:

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.


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Study Type : Observational
Actual Enrollment : 406 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Group/Cohort Intervention/treatment
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)




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Painful hospitalized patient
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193762


Locations
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France
Lille Catholic Hospitals
Lille, Nord, France, 59462
Roubaix Hospital
Roubaix, France, 59100
Tourcoing hospital
Tourcoing, France, 59200
Wattrelos hospital
Wattrelos, France, 59150
Sponsors and Collaborators
Lille Catholic University
Centre Hospitalier de Roubaix
Tourcoing Hospital
Wattrelos hospital
Investigators
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Principal Investigator: Vincent Ducoulombier, MD Lille Catholic University

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Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT03193762     History of Changes
Other Study ID Numbers: OBS-0024
2017-A00482-51 ( Other Identifier: ANSM )
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lille Catholic University:
pain
pain management
anxiety

Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders