NCT02690597

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 5, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 3, 2018

Status Verified

November 1, 2018

Enrollment Period

1.8 years

First QC Date

February 5, 2016

Last Update Submit

November 29, 2018

Conditions

AnxietyPain

Keywords

Anxiety analogic visual scalePainState Trait Inventory anxiety scaleAnxiety

Outcome Measures

Primary Outcomes (4)

  • 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

    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

    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

    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

    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

    Baseline

  • Evaluation of pain consultation impact on anxiety part of pain as assessed by anxiety levels obtained with anxiety analogic visual scale score

    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

    Baseline

  • Evaluation of clinical utility of anxiety analogic visual scale in nursing care as assessed by anxiety levels anxiety analogic visual scale score

    Baseline

Study Arms (1)

Patient

OTHER

State-trait anxiety inventory Y-A form (STAI Y-A form) Anxiety visual analog scale evaluation(A-AVS).

Other: Anxiety visual analog scale

Interventions

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

Patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Inability of patient to understand the study procedures and thus inability to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Rangueil

Toulouse, France

Location

MeSH Terms

Conditions

Anxiety DisordersPain

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jean-Christophe FOISSAC, Nurse

    CHU Rangueil

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2016

First Posted

February 24, 2016

Study Start

February 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 3, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)