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

Completed

• Conditions: Pain; Anxiety
• Interventions: Other: Anxiety VAS

• Registration Number: NCT03193762
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-06-19
• Study First Submitted QC: 2017-06-20
• Study First Posted: 2017-06-21
• Study Start: 2017-08-07
• Primary Completion: 2018-06-01
• Study Completion: 2018-09-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-21
• Last Update Posted: 2019-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 406

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Painful hospitalized patient	Anxiety VAS	The anxiety of those patients will be measured with an Anxiety VAS

Primary Outcome Measures

Name	Time	Method
Correlation between Anxiety VAS and STAI-Ya and HAD-7A scores	at inclusion	Correlation between Anxiety-VAS and STAI-Ya, HAD-7A scores.

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Roubaix Hospital; 🇫🇷 Roubaix, France

Tourcoing hospital; 🇫🇷 Tourcoing, France

Wattrelos hospital; 🇫🇷 Wattrelos, France

Lille Catholic Hospitals; 🇫🇷 Lille, Nord, France