Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01423409
Recruitment Status : Completed
First Posted : August 25, 2011
Last Update Posted : July 23, 2013
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Deafness Visual Analog Pain Scale Device: pictorial VAS Device: usual VAS Phase 2 Phase 3

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 289 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of an Innovative Visual Analogue Scale of Pain (Pictorial VAS) Versus the Usual VAS (VAS) Among Deaf People
Study Start Date : June 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Average scores of pain between the both groups: pictorial VAS versus usual VAS [ Time Frame: one hour ]
    pain score

  2. Analgesic treatment between the both groups : pictorial VAS versus usual VAS [ Time Frame: one hour ]
    analgesic treatment

  3. Pain score and analgesic treatment before and after French Sign Language (FSL) explanations [ Time Frame: one hour ]
    pain score and analgesic treatment


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01423409


Locations
Layout table for location information
France
University Hospital
Grenoble, France
University Hospital
Marseille, France
La Pitié-Salpêtrière
Paris, France
University Hospital
Strasbourg, France
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Layout table for investigator information
Principal Investigator: Benoit Mongourdin, PH University Hospital, Grenoble
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:
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).

Layout table for additonal information
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01423409    
Other Study ID Numbers: EVA SOURD study
First Posted: August 25, 2011    Key Record Dates
Last Update Posted: July 23, 2013
Last Verified: April 2013
Keywords provided by University Hospital, Grenoble:
visual analog pain scale
Deaf persons
clinical trial
multicentric
Additional relevant MeSH terms:
Layout table for MeSH terms
Deafness
Hearing Loss
Hearing Disorders
Ear Diseases
 Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases