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Completed

NCT Number: NCT01423409

Multicenter Trial Assessing an Innovative VAS of Pain Among Deaf People

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.

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Key information

Conditions

Deafness Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Visual Analog Pain Scale

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University Hospital, Grenoble, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pictorial VAS

Device

Pictorial VAS includes elements which promote understanding of Deaf people: colours and 6 detailed expressive faces.

usual VAS

Device

usual visual analog scale (VAS) of pain (line from 0: no pain to 10:worst pain)

Primary outcomes

  1. 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

Secondary outcomes

  1. Average scores of pain between the both groups: pictorial VAS versus usual VAS

    Time frame: one hour

    pain score

  2. Analgesic treatment between the both groups : pictorial VAS versus usual VAS

    Time frame: one hour

    analgesic treatment

  3. Pain score and analgesic treatment before and after French Sign Language (FSL) explanations

    Time frame: one hour

    pain score and analgesic treatment

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: EVA_SOURD

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 25, 2011
Registry last updated
Jul 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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