NCT01423409

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
289

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 25, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

July 23, 2013

Status Verified

April 1, 2013

Enrollment Period

2 years

First QC Date

July 22, 2011

Last Update Submit

July 22, 2013

Conditions

DeafnessVisual Analog Pain Scale

Keywords

visual analog pain scaleDeaf personsclinical trialmulticentric

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Average scores of pain between the both groups: pictorial VAS versus usual VAS

    one hour

  • Analgesic treatment between the both groups : pictorial VAS versus usual VAS

    one hour

  • Pain score and analgesic treatment before and after French Sign Language (FSL) explanations

    one hour

Study Arms (2)

pictorial VAS

ACTIVE COMPARATOR

VAS with colours and 6 expressive faces

Device: pictorial VAS

usual VAS

SHAM COMPARATOR

VAS

Device: usual VAS

Interventions

pictorial VASDEVICE

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

pictorial VAS
usual VASDEVICE

usual visual analog scale (VAS) of pain (line from 0: no pain to 10:worst pain)

usual VAS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Hospital

Grenoble, France

Location

University Hospital

Marseille, France

Location

La Pitié-Salpêtrière

Paris, France

Location

University Hospital

Strasbourg, France

Location

Related Publications (7)

  • Dagron J. [Deafness and recourse to help, starting the dialog]. Soins. 2001 Dec;(661):37-9. No abstract available. French.

    PMID: 12012932BACKGROUND

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

    BACKGROUND

  • 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.

    BACKGROUND

  • Gillot Dominique. Le Droit des Sourds. Juin 1998. (mis en ligne le date : http://www.sante.gouv.fr/).

    BACKGROUND

  • Loi n°2005-102 du 11 février 2005. Pour l'égalité des droits et des chances, la participation et la citoyenneté des personnes handicapées.

    BACKGROUND

  • Circulaire ministérielle n°DHOS/E1/DGS/SD1B/SD1C/SD4A/2006/90 du 2 mars 2006. La Charte de la personne hospitalisée.

    BACKGROUND

  • Circulaire N°99-84 du 11.02.1999. (Relative à la mise en place de protocole de prise en charge de la douleur).

    BACKGROUND

MeSH Terms

Conditions

Deafness

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Benoit Mongourdin, PH

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2011

First Posted

August 25, 2011

Study Start

June 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

July 23, 2013

Record last verified: 2013-04

Locations

FR(4)