Multicenter Trial Assessing an Innovative VAS of Pain Among Deaf People

Phase 2

Completed

• Conditions: Deafness; Visual Analog Pain Scale
• Interventions: Device: usual VAS; Device: pictorial VAS

• Registration Number: NCT01423409
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-22
• Study First Submitted QC: 2011-08-24
• Study First Posted: 2011-08-25
• Status Verified: 2013-04
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Last Update Submitted: 2013-07-22
• Last Update Posted: 2013-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 289

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
usual VAS	usual VAS	VAS
pictorial VAS	pictorial VAS	VAS with colours and 6 expressive faces

Primary Outcome Measures

Name	Time	Method
Innovative Visual Analogue Scale of Pain (Pictorial VAS) Versus the Usual VAS (VAS) Among Deaf People	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

Secondary Outcome Measures

Name	Time	Method
Average scores of pain between the both groups: pictorial VAS versus usual VAS	one hour	pain score
Analgesic treatment between the both groups : pictorial VAS versus usual VAS	one hour	analgesic treatment
Pain score and analgesic treatment before and after French Sign Language (FSL) explanations	one hour	pain score and analgesic treatment

Trial Locations

Locations (2)

University Hospital; 🇫🇷 Strasbourg, France

La Pitié-Salpêtrière; 🇫🇷 Paris, France