AnxietyANXYDOLNCT02690597
Validation and Pertinence of Anxiety Analogic Visual Scale in Pain Management
A study testing Anxiety visual analog scale in people with Anxiety and Pain, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Screening of anxiogenic part of pain is an imperative during a medical pain consultation. The actual tools for evaluation of this specific part are complex and time consuming. To date, it lacked a reliable and reproductive tool to quickly evaluate anxiety of patient in pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Anxiety visual analog scale
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Dec 2016
- Phase
- Interventional
- 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
Who may be able to join
- Signed and dated informed consent
- Male or female aged from ≥ 18 years old
- Perfect patient ability to understand and write French
- Patient with a pain threshold permitting a initial medication free consultation and completion of anxiety surveys.
Who cannot join
- Inability of patient to understand the study procedures and thus inability to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation and Pertinence of Anxiety Analogic Visual Scale in Pain Management by Mobile Acute Pain Team
Screening of anxiogenic part of pain is an imperative during a medical pain consultation. The actual tools for evaluation of this specific part are complex and time consuming.
To date, it lacked a reliable and reproductive tool to quickly evaluate anxiety of patient in pain. The purpose of this study is to demonstrate the pertinence and validity of anxiety analogic visual scale by comparison with the actual reference the self-assessment questionnaire State Trait Inventory Anxiety Y-A form.
- Being tested
- Anxiety visual analog scale
- Keywords
- Anxiety analogic visual scale, Pain, State Trait Inventory anxiety scale, Anxiety
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anxiety visual analog scaleOther
Anxiety visual analog scale is a test of evaluation of anxiety done by the patient, this scale do not include number and the patient have to place a coloured marker at the level indicating his anxiety feeling
| Study group | Role | What they receive |
|---|---|---|
| Patient | Other | State-trait anxiety inventory Y-A form (STAI Y-A form)
Anxiety visual analog scale evaluation(A-AVS). Receives: Other: Anxiety visual analog scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of pertinence of anxiety analogic visual scale in systematic use as assessed by anxiety levels obtained with State Trait of anxiety Y-A form score
The patient's inclusion take place during the only study participation day of the patient
Measured: Baseline
Evaluation of validity of anxiety analogic visual scale in systematic use as assessed by anxiety levels obtained with State Trait of anxiety Y-A form score
The patient's inclusion take place during the only study participation day of the patient
Measured: Baseline
Evaluation of pertinence of anxiety analogic visual scale in systematic use as assessed by anxiety levels obtained with anxiety analogic visual scale score
The patient's inclusion take place during the only study participation day of the patient
Measured: Baseline
Evaluation of validity of anxiety analogic visual scale in systematic use as assessed by anxiety levels obtained with anxiety analogic visual scale score
The patient's inclusion take place during the only study participation day of the patient
Measured: Baseline
Secondary outcomes (4)
Evaluation of pain consultation impact on anxiety part of pain as assessed by anxiety levels obtained with State Trait of anxiety Y-A form score
The patient's inclusion take place during the only study participation day of the patient
Measured: Baseline
Evaluation of pain consultation impact on anxiety part of pain as assessed by anxiety levels obtained with anxiety analogic visual scale score
The patient's inclusion take place during the only study participation day of the patient
Measured: Baseline
Evaluation of clinical utility of anxiety analogic visual scale in nursing care as assessed by anxiety levels obtained with State Trait of anxiety Y-A form score
The patient's inclusion take place during the only study participation day of the patient
Measured: Baseline
Evaluation of clinical utility of anxiety analogic visual scale in nursing care as assessed by anxiety levels anxiety analogic visual scale score
The patient's inclusion take place during the only study participation day of the patient
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startFeb 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Christophe FOISSAC, Nurse, Principal investigator, CHU Rangueil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690597
- Sponsor's protocol ID
- 12 560 07
- Other IDs
- 2013-A00451-44
- Acronym
- ANXYDOL
- Status last verified
- Nov 2018
- First submitted
- 5 Feb 2016
- Last updated
- 3 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Pertinence of Anxiety Analogic Visual Scale in Pain Management by Mobile Acute Pain Team
- ClinicalTrials.gov ID
- NCT02690597
- Acronym / sponsor ID
- ANXYDOL / 12 560 07
- Keywords
- Anxiety analogic visual scale, Pain, State Trait Inventory anxiety scale, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 24 Feb 2016 (estimated)
- 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.
Screening of anxiogenic part of pain is an imperative during a medical pain consultation. The actual tools for evaluation of this specific part are complex and time consuming.
To date, it lacked a reliable and reproductive tool to quickly evaluate anxiety of patient in pain. The purpose of this study is to demonstrate the pertinence and validity of anxiety analogic visual scale by comparison with the actual reference the self-assessment questionnaire State Trait Inventory Anxiety Y-A form.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | Other | Other: Anxiety visual analog scaleState-trait anxiety inventory Y-A form (STAI Y-A form) Anxiety visual analog scale evaluation(A-AVS). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed and dated informed consent
- Male or female aged from ≥ 18 years old
- Perfect patient ability to understand and write French
- Patient with a pain threshold permitting a initial medication free consultation and completion of anxiety surveys.
Key exclusion criteria (1 listed)
- Inability of patient to understand the study procedures and thus inability to give informed consent.
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 visual analog scaleAnxiety visual analog scale is a test of evaluation of anxiety done by the patient, this scale do not include number and the patient have to place a coloured marker at the level indicating his anxiety feeling | Other | Patient |
Primary outcome
Evaluation of pertinence of anxiety analogic visual scale in systematic use as assessed by anxiety levels obtained with State Trait of anxiety Y-A form score
Time frame: Baseline
The patient's inclusion take place during the only study participation day of the patient
Evaluation of validity of anxiety analogic visual scale in systematic use as assessed by anxiety levels obtained with State Trait of anxiety Y-A form score
Time frame: Baseline
The patient's inclusion take place during the only study participation day of the patient
Evaluation of pertinence of anxiety analogic visual scale in systematic use as assessed by anxiety levels obtained with anxiety analogic visual scale score
Time frame: Baseline
The patient's inclusion take place during the only study participation day of the patient
Evaluation of validity of anxiety analogic visual scale in systematic use as assessed by anxiety levels obtained with anxiety analogic visual scale score
Time frame: Baseline
The patient's inclusion take place during the only study participation day of the patient
4 secondary outcomes
Evaluation of pain consultation impact on anxiety part of pain as assessed by anxiety levels obtained with State Trait of anxiety Y-A form score
Time frame: Baseline
Evaluation of pain consultation impact on anxiety part of pain as assessed by anxiety levels obtained with anxiety analogic visual scale score
Time frame: Baseline
Evaluation of clinical utility of anxiety analogic visual scale in nursing care as assessed by anxiety levels obtained with State Trait of anxiety Y-A form score
Time frame: Baseline
Evaluation of clinical utility of anxiety analogic visual scale in nursing care as assessed by anxiety levels anxiety analogic visual scale score
Time frame: Baseline
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 3 Dec 2018.
- 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.
Jean-Christophe FOISSAC, Nurse principal investigator
CHU Rangueil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anxiety visual analog scale in people with Anxiety and Pain, run by University Hospital, Toulouse at 1 site 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 4 inclusion and 1 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 3 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Evaluation of pertinence of anxiety analogic visual scale in systematic use as assessed by anxiety levels obtained with State Trait of anxiety Y-A form score (time frame: Baseline). The study lists 4 primary outcomes in all. 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 3 Dec 2018.