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

Pain Clinical Trial

— EVANX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03193762
• Other study ID #: OBS-0024
• Secondary ID: 2017-A00482-51
• Status: Completed
• Start date: August 7, 2017
• Est. completion date: September 1, 2018

Study information

• Verified date: March 2019
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 406
• Est. completion date: September 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain

Intervention

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

Locations

Country	Name	City	State
France	Lille Catholic Hospitals	Lille	Nord
France	Roubaix Hospital	Roubaix
France	Tourcoing hospital	Tourcoing
France	Wattrelos hospital	Wattrelos

Sponsors (4)

Lead Sponsor	Collaborator
Lille Catholic University	Roubaix hospital, Tourcoing Hospital, Wattrelos hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between Anxiety VAS and STAI-Ya and HAD-7A scores	Correlation between Anxiety-VAS and STAI-Ya, HAD-7A scores.	at inclusion
Secondary	Number of patients presenting anxiety.	Number of patients presenting significant anxiety according to the different scales used.	at inclusion
Secondary	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
Secondary	Concordance between STAI-Ya and HAD-7A scales.	Correlation between STAI-Ya and HAD-7A scores.	at inclusion