Multicenter Trial Assessing an Innovative VAS of Pain Among Deaf People (EVA_SOURD)
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|ClinicalTrials.gov Identifier: NCT01423409|
Recruitment Status : Completed
First Posted : August 25, 2011
Last Update Posted : July 23, 2013
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 or disease||Intervention/treatment||Phase|
|Deafness Visual Analog Pain Scale||Device: pictorial VAS Device: usual VAS||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||289 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of an Innovative Visual Analogue Scale of Pain (Pictorial VAS) Versus the Usual VAS (VAS) Among Deaf People|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
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
Device: usual VAS
usual visual analog scale (VAS) of pain (line from 0: no pain to 10:worst pain)
- Innovative Visual Analogue Scale of Pain (Pictorial VAS) Versus the Usual VAS (VAS) Among Deaf People [ Time Frame: one hour ]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
- Average scores of pain between the both groups: pictorial VAS versus usual VAS [ Time Frame: one hour ]pain score
- Analgesic treatment between the both groups : pictorial VAS versus usual VAS [ Time Frame: one hour ]analgesic treatment
- Pain score and analgesic treatment before and after French Sign Language (FSL) explanations [ Time Frame: one hour ]pain score and analgesic treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01423409
|Principal Investigator:||Benoit Mongourdin, PH||University Hospital, Grenoble|