Multicenter Trial Assessing an Innovative VAS of Pain Among Deaf People

Deafness Clinical Trial

— EVA_SOURD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01423409
• Other study ID #: EVA SOURD study
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 22, 2011
• Last updated: July 22, 2013
• Start date: June 2011
• Est. completion date: June 2013

Study information

• Verified date: April 2013
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 289
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Deafness
• Visual Analog Pain Scale

Intervention

Device:
• pictorial VAS
Pictorial VAS includes elements which promote understanding of Deaf people: colours and 6 detailed expressive faces.
• usual VAS
usual visual analog scale (VAS) of pain (line from 0: no pain to 10:worst pain)

Locations

Country	Name	City	State
France	University Hospital	Grenoble
France	University Hospital	Marseille
France	La Pitié-Salpêtrière	Paris
France	University Hospital	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (7)

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).

Dagron J .Les silencieux. Chroniques de vingt ans de médecine avec les Sourds. Editions : Presse Pluriel, Paris. 2008 ; 287 p.

Dagron J. [Deafness and recourse to help, starting the dialog]. Soins. 2001 Dec;(661):37-9. French. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Innovative Visual Analogue Scale of Pain (Pictorial VAS) Versus the Usual VAS (VAS) Among Deaf People	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	Yes
Secondary	Average scores of pain between the both groups: pictorial VAS versus usual VAS	pain score	one hour	Yes
Secondary	Analgesic treatment between the both groups : pictorial VAS versus usual VAS	analgesic treatment	one hour	Yes
Secondary	Pain score and analgesic treatment before and after French Sign Language (FSL) explanations	pain score and analgesic treatment	one hour	Yes