NCT03193762

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
406

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

4 active sites

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

First Submitted

Initial submission to the registry

June 19, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

August 7, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

March 22, 2019

Status Verified

March 1, 2019

Enrollment Period

10 months

First QC Date

June 19, 2017

Last Update Submit

March 21, 2019

Conditions

PainAnxiety

Keywords

painpain managementanxiety

Outcome Measures

Primary Outcomes (1)

  • Correlation between Anxiety VAS and STAI-Ya and HAD-7A scores

    Correlation between Anxiety-VAS and STAI-Ya, HAD-7A scores.

    at inclusion

Secondary Outcomes (3)

  • Number of patients presenting anxiety.

    at inclusion

  • Link between anxiety scores and several factors

    at inclusion

  • Concordance between STAI-Ya and HAD-7A scales.

    at inclusion

Study Arms (1)

Painful hospitalized patient

The anxiety of those patients will be measured with an Anxiety VAS

Other: Anxiety VAS

Interventions

Anxiety VASOTHER

Anxiety will be measure with a 10-points visual analogic scale (VAS)

Painful hospitalized patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Painful hospitalized patient

You may qualify if:

  • Aged ≥ 18 years old
  • Patient hospitalized in a medical or chirurgical service.
  • Patient presenting a moderate to acute pain (Pain VAS ≥4)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Lille Catholic Hospitals

Lille, Nord, 59462, France

Location

Roubaix Hospital

Roubaix, 59100, France

Location

Tourcoing hospital

Tourcoing, 59200, France

Location

Wattrelos hospital

Wattrelos, 59150, France

Location

MeSH Terms

Conditions

PainAnxiety DisordersAgnosia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Vincent Ducoulombier, MD

    Lille Catholic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2017

First Posted

June 21, 2017

Study Start

August 7, 2017

Primary Completion

June 1, 2018

Study Completion

September 1, 2018

Last Updated

March 22, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)