PainEVANXNCT03193762
Usefulness of a Visual Analogue Scale to Evaluate Anxiety in the Painful Hospitalized Patient
An observational study of Pain and Anxiety, run by Lille Catholic University at 4 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Anxiety VAS
- How many people
- 406 participants
- Where
- 4 sitesFrance
- Study dates
- 7 Aug 2017to 1 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Painful hospitalized patient
Who may be able to join
- Aged ≥ 18 years old
- Patient hospitalized in a medical or chirurgical service.
- Patient presenting a moderate to acute pain (Pain VAS ≥4)
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
Lille Catholic Hospitals
Lille, Nord, 59462
Roubaix Hospital
Roubaix, 59100
Tourcoing hospital
Tourcoing, 59200
Wattrelos hospital
Wattrelos, 59150
About this study
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.
Read the 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.
- Being tested
- Anxiety VAS
- Keywords
- pain, pain management, anxiety
- Medical subject headings
- Pain, Anxiety Disorders, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anxiety VASOther
Anxiety will be measure with a 10-points visual analogic scale (VAS)
| Study group | Role | What they receive |
|---|---|---|
| Painful hospitalized patient | The anxiety of those patients will be measured with an Anxiety VAS Receives: Other: Anxiety VAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Anxiety VAS and STAI-Ya and HAD-7A scores
Correlation between Anxiety-VAS and STAI-Ya, HAD-7A scores.
Measured: at inclusion
Secondary outcomes (3)
Number of patients presenting anxiety.
Number of patients presenting significant anxiety according to the different scales used.
Measured: 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
Measured: at inclusion
Concordance between STAI-Ya and HAD-7A scales.
Correlation between STAI-Ya and HAD-7A scores.
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start7 Aug 2017
- Primary completion1 Jun 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier de Roubaix, Tourcoing Hospital, Wattrelos hospital
- Responsible party
- Sponsor
- Investigators
- Vincent Ducoulombier, MD, Principal investigator, Lille Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193762
- Sponsor's protocol ID
- OBS-0024
- Other IDs
- 2017-A00482-51
- Acronym
- EVANX
- Status last verified
- Mar 2019
- First submitted
- 19 Jun 2017
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of a Visual Analogue Scale to Evaluate Anxiety in the Painful Hospitalized Patient
- ClinicalTrials.gov ID
- NCT03193762
- Acronym / sponsor ID
- EVANX / OBS-0024
- Keywords
- pain, pain management, anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Collaborators
- Centre Hospitalier de Roubaix, Tourcoing Hospital, Wattrelos hospital
- Study start
- 7 Aug 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 21 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Painful hospitalized patient | – | Other: Anxiety VASThe anxiety of those patients will be measured with an Anxiety VAS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Painful hospitalized patient
Key inclusion criteria (3 listed)
- Aged ≥ 18 years old
- Patient hospitalized in a medical or chirurgical service.
- Patient presenting a moderate to acute pain (Pain VAS ≥4)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anxiety VASAnxiety will be measure with a 10-points visual analogic scale (VAS) | Other | Painful hospitalized patient |
Primary outcome
Correlation between Anxiety VAS and STAI-Ya and HAD-7A scores
Time frame: at inclusion
Correlation between Anxiety-VAS and STAI-Ya, HAD-7A scores.
3 secondary outcomes
Number of patients presenting anxiety.
Time frame: at inclusion
Link between anxiety scores and several factors
Time frame: at inclusion
Concordance between STAI-Ya and HAD-7A scales.
Time frame: at inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Ducoulombier, MD principal investigator
Lille Catholic University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Anxiety, run by Lille Catholic University at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between Anxiety VAS and STAI-Ya and HAD-7A scores (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2019.