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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Anxiety
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 406

Contacts and Locations

Study Locations

• France
  • Roubaix, France, 59100
    • Roubaix hospital
  • Tourcoing, France, 59200
    • Tourcoing Hospital
  • Wattrelos, France, 59150
    • Wattrelos hospital
  • Nord
    • Lille, Nord, France, 59462
      • Lille Catholic Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Painful hospitalized patient

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between Anxiety VAS and STAI-Ya and HAD-7A scores	Correlation between Anxiety-VAS and STAI-Ya, HAD-7A scores.	at inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients presenting anxiety.	Number of patients presenting significant anxiety according to the different scales used.	at inclusion
Link between anxiety scores and several factors	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	at inclusion
Concordance between STAI-Ya and HAD-7A scales.	Correlation between STAI-Ya and HAD-7A scores.	at inclusion

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Collaborators: Tourcoing Hospital; Centre Hospitalier de Roubaix; Wattrelos hospital
• Investigators: Principal Investigator: Vincent Ducoulombier, MD, Lille Catholic University

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2017
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: June 19, 2017
• First Submitted That Met QC Criteria: June 20, 2017
• First Posted (Actual): June 21, 2017

Study Record Updates

• Last Update Posted (Actual): March 22, 2019
• Last Update Submitted That Met QC Criteria: March 21, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: pain; anxiety; pain management
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: OBS-0024; 2017-A00482-51 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No