Clinical trial NCT01423409: Multicenter Trial Assessing an Innovative VAS of Pain Among Deaf People
Official title: Assessment of an Innovative Visual Analogue Scale of Pain (Pictorial VAS) Versus the Usual VAS (VAS) Among Deaf People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Deafness
Visual Analog Pain Scale
Keywords: visual analog pain scale
Deaf persons
clinical trial
multicentric
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2011-08-25
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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

Primary outcomes:
measure: Innovative Visual Analogue Scale of Pain (Pictorial VAS) Versus the Usual VAS (VAS) Among Deaf People
timeFrame: one hour
Secondary outcomes:
measure: Average scores of pain between the both groups: pictorial VAS versus usual VAS
timeFrame: one hour
measure: Analgesic treatment between the both groups : pictorial VAS versus usual VAS
timeFrame: one hour
measure: Pain score and analgesic treatment before and after French Sign Language (FSL) explanations
timeFrame: one hour
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital
city: Marseille
country: France
facility: University Hospital
city: Paris
country: France
facility: La Pitié-Salpêtrière
city: Strasbourg
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Grenoble
name: Benoit Mongourdin, PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dagron J. [Deafness and recourse to help, starting the dialog]. Soins. 2001 Dec;(661):37-9. No abstract available. French.
citation: Dagron J .Les silencieux. Chroniques de vingt ans de médecine avec les Sourds. Editions : Presse Pluriel, Paris. 2008 ; 287 p.
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.
citation: Gillot Dominique. Le Droit des Sourds. Juin 1998. (mis en ligne le date : http://www.sante.gouv.fr/).
citation: Loi n°2005-102 du 11 février 2005. Pour l'égalité des droits et des chances, la participation et la citoyenneté des personnes handicapées.
citation: Circulaire ministérielle n°DHOS/E1/DGS/SD1B/SD1C/SD4A/2006/90 du 2 mars 2006. La Charte de la personne hospitalisée.
citation: Circulaire N°99-84 du 11.02.1999. (Relative à la mise en place de protocole de prise en charge de la douleur).