Clinical trial NCT03193762: Usefulness of a Visual Analogue Scale to Evaluate Anxiety in the Painful Hospitalized Patient
Official title: Usefulness of a Visual Analogue Scale to Evaluate Anxiety in the Painful Hospitalized Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Anxiety
Keywords: pain
pain management
anxiety
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier de Roubaix
name: Tourcoing Hospital
name: Wattrelos hospital
First posted: 2017-06-21
Enrollment: 406
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Painful hospitalized patient

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.

Eligibility 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

Primary outcomes:
measure: Correlation between Anxiety VAS and STAI-Ya and HAD-7A scores
timeFrame: at inclusion
Secondary outcomes:
measure: Number of patients presenting anxiety.
timeFrame: at inclusion
measure: Link between anxiety scores and several factors
timeFrame: at inclusion
measure: Concordance between STAI-Ya and HAD-7A scales.
timeFrame: at inclusion
Other outcomes:
Locations:
city: Lille
country: France
facility: Lille Catholic Hospitals
state: Nord
city: Roubaix
country: France
facility: Roubaix Hospital
city: Tourcoing
country: France
facility: Tourcoing hospital
city: Wattrelos
country: France
facility: Wattrelos hospital
Study officials:
affiliation: Lille Catholic University
name: Vincent Ducoulombier, MD
role: PRINCIPAL_INVESTIGATOR
References: