Multicenter Trial Assessing an Innovative VAS of Pain Among Deaf People (EVA_SOURD)

July 22, 2013 updated by: University Hospital, Grenoble

Assessment of an Innovative Visual Analogue Scale of Pain (Pictorial VAS) Versus the Usual VAS (VAS) Among Deaf People

The purpose of this study is to assess an innovative Visual Analogue Scale of pain (pictorial VAS) versus the usual VAS (VAS) among Deaf People.

The assumption of this study is that pictorial VAS is more suited to Deaf people than usual VAS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Indeed French literature showed that 80% of Deaf people are illiterate. Moreover, lip-reading only allows to recognize one third of words.

Pictorial VAS includes elements which promote understanding of Deaf people: colours and 6 detailed expressive faces.

Study Type

Interventional

Enrollment (Actual)

289

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France
        • University Hospital
      • Marseille, France
        • University Hospital
      • Paris, France
        • La Pitié-Salpétrière
      • Strasbourg, France
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • people aged over 18 years old
  • Deaf people
  • affiliation to the french social security system or equivalent
  • people who signed the consent form

Exclusion Criteria:

  • hearing people
  • people who became deaf
  • pregnant or breastfeeding women
  • people deprived of freedom
  • people hospitalized without consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: pictorial VAS
VAS with colours and 6 expressive faces
Device: pictorial VAS
Pictorial VAS includes elements which promote understanding of Deaf people: colours and 6 detailed expressive faces.
Sham Comparator: usual VAS
VAS
Device: usual VAS
usual visual analog scale (VAS) of pain (line from 0: no pain to 10:worst pain)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Innovative Visual Analogue Scale of Pain (Pictorial VAS) Versus the Usual VAS (VAS) Among Deaf People
Time Frame: one hour
an innovative visual analogue scale of pain (pictorial vas) versus the usual vas (vas) among deaf people, at hospital, in terms of good understanding of pain
one hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average scores of pain between the both groups: pictorial VAS versus usual VAS
Time Frame: one hour
pain score
one hour
Analgesic treatment between the both groups : pictorial VAS versus usual VAS
Time Frame: one hour
analgesic treatment
one hour
Pain score and analgesic treatment before and after French Sign Language (FSL) explanations
Time Frame: one hour
pain score and analgesic treatment
one hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Benoit Mongourdin, PH, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Dagron J. [Deafness and recourse to help, starting the dialog]. Soins. 2001 Dec;(661):37-9. No abstract available. French.
  • Dagron J .Les silencieux. Chroniques de vingt ans de médecine avec les Sourds. Editions : Presse Pluriel, Paris. 2008 ; 287 p.
  • Delaporte Y. Chapitre 1 : Qui sont les Sourds, histoire d'un mot. In : Les Sourds, c'est comme ça. Editions de la Maison des sciences de l'homme, Paris 2002 ; 398 p.
  • Gillot Dominique. Le Droit des Sourds. Juin 1998. (mis en ligne le date : http://www.sante.gouv.fr/).
  • Loi n°2005-102 du 11 février 2005. Pour l'égalité des droits et des chances, la participation et la citoyenneté des personnes handicapées.
  • Circulaire ministérielle n°DHOS/E1/DGS/SD1B/SD1C/SD4A/2006/90 du 2 mars 2006. La Charte de la personne hospitalisée.
  • Circulaire N°99-84 du 11.02.1999. (Relative à la mise en place de protocole de prise en charge de la douleur).

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

July 22, 2011

First Submitted That Met QC Criteria

August 24, 2011

First Posted (Estimate)

August 25, 2011

Study Record Updates

Last Update Posted (Estimate)

July 23, 2013

Last Update Submitted That Met QC Criteria

July 22, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVA SOURD study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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