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

NCT ID: NCT03193762

Last Updated: 2019-03-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 406 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-07
• Study Completion Date: 2018-09-01

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.

Conditions

Pain; Anxiety

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Painful hospitalized patient

The anxiety of those patients will be measured with an Anxiety VAS

Anxiety VAS

Intervention Type: OTHER

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

Interventions

Anxiety VAS

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier de Roubaix

OTHER

Sponsor Role: collaborator

Tourcoing Hospital

OTHER

Sponsor Role: collaborator

Wattrelos hospital

UNKNOWN

Sponsor Role: collaborator

Lille Catholic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Ducoulombier, MD

Role: PRINCIPAL_INVESTIGATOR

Lille Catholic University

Locations

Lille Catholic Hospitals

Lille, Nord, France

Roubaix Hospital

Roubaix, , France

Tourcoing hospital

Tourcoing, , France

Wattrelos hospital

Wattrelos, , France

Countries

France

Other Identifiers

2017-A00482-51

Identifier Type: OTHER

Identifier Source: secondary_id

OBS-0024

Identifier Type: -

Identifier Source: org_study_id