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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
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 5, 2016
Last Updated
November 29, 2018
Sponsor
University Hospital, Toulouse
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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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