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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01423409
First received: July 22, 2011
Last updated: July 22, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Deafness
Visual Analog Pain Scale
Device: pictorial VAS
Device: usual VAS
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Innovative Visual Analogue Scale of Pain (Pictorial VAS) Versus the Usual VAS (VAS) Among Deaf People [ Time Frame: one hour ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: one hour ] [ Designated as safety issue: Yes ]
    pain score

  • Analgesic treatment between the both groups : pictorial VAS versus usual VAS [ Time Frame: one hour ] [ Designated as safety issue: Yes ]
    analgesic treatment

  • Pain score and analgesic treatment before and after French Sign Language (FSL) explanations [ Time Frame: one hour ] [ Designated as safety issue: Yes ]
    pain score and analgesic treatment


Enrollment: 289
Study Start Date: June 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01423409

Locations
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
Principal Investigator: Benoit Mongourdin, PH University Hospital, Grenoble
  More Information

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

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01423409     History of Changes
Other Study ID Numbers: EVA SOURD study
Study First Received: July 22, 2011
Last Updated: July 22, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
visual analog pain scale
Deaf persons
clinical trial
multicentric

Additional relevant MeSH terms:
Deafness
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014