Validation and Pertinence of Anxiety Analogic Visual Scale in Pain Management (ANXYDOL)
Primary Purpose
Anxiety, Pain
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Anxiety visual analog scale
Sponsored by

About this trial
This is an interventional health services research trial for Anxiety focused on measuring Anxiety analogic visual scale, Pain, State Trait Inventory anxiety scale, Anxiety
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Inability of patient to understand the study procedures and thus inability to give informed consent.
Sites / Locations
- CHU Rangueil
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patient
Arm Description
State-trait anxiety inventory Y-A form (STAI Y-A form) Anxiety visual analog scale evaluation(A-AVS).
Outcomes
Primary Outcome Measures
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
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
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
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
Secondary Outcome Measures
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
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
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
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
Full Information
NCT ID
NCT02690597
First Posted
February 5, 2016
Last Updated
November 29, 2018
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT02690597
Brief Title
Validation and Pertinence of Anxiety Analogic Visual Scale in Pain Management
Acronym
ANXYDOL
Official Title
Validation and Pertinence of Anxiety Analogic Visual Scale in Pain Management by Mobile Acute Pain Team
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Pain
Keywords
Anxiety analogic visual scale, Pain, State Trait Inventory anxiety scale, Anxiety
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient
Arm Type
Other
Arm Description
State-trait anxiety inventory Y-A form (STAI Y-A form)
Anxiety visual analog scale evaluation(A-AVS).
Intervention Type
Other
Intervention Name(s)
Anxiety visual analog scale
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Description
The patient's inclusion take place during the only study participation day of the patient
Time Frame
Baseline
Title
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
Description
The patient's inclusion take place during the only study participation day of the patient
Time Frame
Baseline
Title
Evaluation of pertinence of anxiety analogic visual scale in systematic use as assessed by anxiety levels obtained with anxiety analogic visual scale score
Description
The patient's inclusion take place during the only study participation day of the patient
Time Frame
Baseline
Title
Evaluation of validity of anxiety analogic visual scale in systematic use as assessed by anxiety levels obtained with anxiety analogic visual scale score
Description
The patient's inclusion take place during the only study participation day of the patient
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
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
Description
The patient's inclusion take place during the only study participation day of the patient
Time Frame
Baseline
Title
Evaluation of pain consultation impact on anxiety part of pain as assessed by anxiety levels obtained with anxiety analogic visual scale score
Description
The patient's inclusion take place during the only study participation day of the patient
Time Frame
Baseline
Title
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
Description
The patient's inclusion take place during the only study participation day of the patient
Time Frame
Baseline
Title
Evaluation of clinical utility of anxiety analogic visual scale in nursing care as assessed by anxiety levels anxiety analogic visual scale score
Description
The patient's inclusion take place during the only study participation day of the patient
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Inability of patient to understand the study procedures and thus inability to give informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Christophe FOISSAC, Nurse
Organizational Affiliation
CHU Rangueil
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Rangueil
City
Toulouse
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Validation and Pertinence of Anxiety Analogic Visual Scale in Pain Management
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