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

Primary Purpose

Deafness, Visual Analog Pain Scale

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
pictorial VAS
usual VAS
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Deafness focused on measuring visual analog pain scale, Deaf persons, clinical trial, multicentric

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital
  • University Hospital
  • La Pitié-Salpêtrière
  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

pictorial VAS

usual VAS

Arm Description

VAS with colours and 6 expressive faces

VAS

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 22, 2011
Last Updated
July 22, 2013
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT01423409
Brief Title
Multicenter Trial Assessing an Innovative VAS of Pain Among Deaf People
Acronym
EVA_SOURD
Official Title
Assessment of an Innovative Visual Analogue Scale of Pain (Pictorial VAS) Versus the Usual VAS (VAS) Among Deaf People
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deafness, Visual Analog Pain Scale
Keywords
visual analog pain scale, Deaf persons, clinical trial, multicentric

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
289 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pictorial VAS
Arm Type
Active Comparator
Arm Description
VAS with colours and 6 expressive faces
Arm Title
usual VAS
Arm Type
Sham Comparator
Arm Description
VAS
Intervention Type
Device
Intervention Name(s)
pictorial VAS
Intervention Description
Pictorial VAS includes elements which promote understanding of Deaf people: colours and 6 detailed expressive faces.
Intervention Type
Device
Intervention Name(s)
usual VAS
Intervention Description
usual visual analog scale (VAS) of pain (line from 0: no pain to 10:worst pain)
Primary Outcome Measure Information:
Title
Innovative Visual Analogue Scale of Pain (Pictorial VAS) Versus the Usual VAS (VAS) Among Deaf People
Description
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
Time Frame
one hour
Secondary Outcome Measure Information:
Title
Average scores of pain between the both groups: pictorial VAS versus usual VAS
Description
pain score
Time Frame
one hour
Title
Analgesic treatment between the both groups : pictorial VAS versus usual VAS
Description
analgesic treatment
Time Frame
one hour
Title
Pain score and analgesic treatment before and after French Sign Language (FSL) explanations
Description
pain score and analgesic treatment
Time Frame
one hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benoit Mongourdin, PH
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Grenoble
Country
France
Facility Name
University Hospital
City
Marseille
Country
France
Facility Name
La Pitié-Salpêtrière
City
Paris
Country
France
Facility Name
University Hospital
City
Strasbourg
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
12012932
Citation
Dagron J. [Deafness and recourse to help, starting the dialog]. Soins. 2001 Dec;(661):37-9. No abstract available. French.
Results Reference
background
Citation
Dagron J .Les silencieux. Chroniques de vingt ans de médecine avec les Sourds. Editions : Presse Pluriel, Paris. 2008 ; 287 p.
Results Reference
background
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.
Results Reference
background
Citation
Gillot Dominique. Le Droit des Sourds. Juin 1998. (mis en ligne le date : http://www.sante.gouv.fr/).
Results Reference
background
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.
Results Reference
background
Citation
Circulaire ministérielle n°DHOS/E1/DGS/SD1B/SD1C/SD4A/2006/90 du 2 mars 2006. La Charte de la personne hospitalisée.
Results Reference
background
Citation
Circulaire N°99-84 du 11.02.1999. (Relative à la mise en place de protocole de prise en charge de la douleur).
Results Reference
background

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Multicenter Trial Assessing an Innovative VAS of Pain Among Deaf People

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