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

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Visual Analog Pain Scale; Deafness

Treatments: Device: usual VAS; Device: pictorial VAS

Study type: Interventional

Funder types: Other

Identifiers

NCT01423409

EVA SOURD study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 289 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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289 participants in 2 patient groups

pictorial VAS

Active Comparator group

Description:

VAS with colours and 6 expressive faces

Treatment:

Device: pictorial VAS

usual VAS

Sham Comparator group

Description:

VAS

Treatment:

Device: usual VAS