Multicenter Trial Assessing an Innovative VAS of Pain Among Deaf People

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessment of an Innovative Visual Analogue Scale of Pain (Pictorial VAS) Versus the Usual VAS (VAS) Among Deaf People

Conditions
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Deafness, Visual Analog Pain Scale

Intervention / Treatment
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* Device: pictorial VAS
* Device: usual VAS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pictorial VAS<br>VAS with colours and 6 expressive faces | Device: pictorial VAS<br>* Pictorial VAS includes elements which promote understanding of Deaf people: colours and 6 detailed expressive faces.<br>|
| Sham Comparator: usual VAS<br>VAS | Device: usual VAS<br>* usual visual analog scale (VAS) of pain (line from 0: no pain to 10:worst pain)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average scores of pain between the both groups: pictorial VAS versus usual VAS | pain score | one hour | 
| Analgesic treatment between the both groups : pictorial VAS versus usual VAS | analgesic treatment | one hour | 
| Pain score and analgesic treatment before and after French Sign Language (FSL) explanations | pain score and analgesic treatment | one hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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visual analog pain scale, Deaf persons, clinical trial, multicentric