Multicenter Trial Assessing an Innovative VAS of Pain Among Deaf People (EVA_SOURD)
This study is currently recruiting participants.
Verified April 2013 by University Hospital, Grenoble
Sponsor:
University Hospital, Grenoble
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01423409
First received: July 22, 2011
Last updated: April 22, 2013
Last verified: April 2013
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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
| Estimated Enrollment: | 302 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | June 2014 |
| Estimated 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
Contacts
| Contact: Sandra DAVID TCHOUDA, MD PHD | 0033476767186 | SDavidTchouda@chu-grenoble.fr |
| Contact: Sandrine MASSICOT, CRA | 0033476768860 | SMassicot@chu-grenoble.fr |
Locations
| France | |
| University Hospital | Recruiting |
| Grenoble, France | |
| Contact: Benoit Mongourdin, PH 0033476765989 BMongourdin@chu-grenoble.fr | |
| Contact: Isabelle Sériès, Nurse 0033476765989 ISeries@chu-grenoble.fr | |
| Principal Investigator: Benoit Mongourdin, PH | |
| Sub-Investigator: Loic Magnen, PH | |
| Sub-Investigator: Pascale Viel, PH | |
| University Hospital | Recruiting |
| Marseille, France | |
| Contact: Jean Dagron, PH 0033491382862 jean.Dagron@ap-hm.fr | |
| Principal Investigator: Jean Dagron, PH | |
| La Pitié-Salpêtrière | Recruiting |
| Paris, France | |
| Contact: Alexis Karacostas, PH 0033142161470 alexis.karacostas@psl.aphp.fr | |
| Principal Investigator: Alexis Karacostas, PH | |
| Sub-Investigator: Jean-Luc Vourch, PH | |
| Sub-Investigator: Catherine Bruneau, PH | |
| University Hospital | Recruiting |
| Strasbourg, France | |
| Contact: Anne-Françoise Besançon, PH 33369550453 anne-francoise.besancon@chru-strasbourg.fr | |
| Principal Investigator: Anne-Françoise Besançon, PH | |
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: | April 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 May 19, 2013