DeafnessPhase 2/3EVA_SOURDNCT01423409
Multicenter Trial Assessing an Innovative VAS of Pain Among Deaf People
A Phase 2/3 study testing pictorial VAS and usual VAS in people with Deafness and Visual Analog Pain Scale, run by University Hospital, Grenoble at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deafness, Visual Analog Pain Scale
- What is being tested?
- pictorial VAS and usual VAS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 289 participants
- Where
- 4 sitesFrance
- Study dates
- Jun 2011to Jun 2013
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- people aged over 18 years old
- Deaf people
- affiliation to the french social security system or equivalent
- people who signed the consent form
Who cannot join
- hearing people
- people who became deaf
- pregnant or breastfeeding women
- people deprived of freedom
- people hospitalized without consent
Trial locations and contacts
4 sites in 1 country.
France4 sites
University Hospital
Grenoble
University Hospital
Marseille
La Pitié-Salpêtrière
Paris
University Hospital
Strasbourg
About this study
Official title: Assessment of an Innovative Visual Analogue Scale of Pain (Pictorial VAS) Versus the Usual VAS (VAS) 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.
Read the 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.
- Conditions
- Deafness, Visual Analog Pain Scale
- Being tested
- pictorial VAS, usual VAS
- Keywords
- visual analog pain scale, Deaf persons, clinical trial, multicentric
- Medical subject headings
- Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pictorial VASDevice
Pictorial VAS includes elements which promote understanding of Deaf people: colours and 6 detailed expressive faces.
usual VASDevice
usual visual analog scale (VAS) of pain (line from 0: no pain to 10:worst pain)
| Study group | Role | What they receive |
|---|---|---|
| pictorial VAS | Active comparator | VAS with colours and 6 expressive faces Receives: Device: pictorial VAS |
| usual VAS | Sham comparator | VAS Receives: Device: usual VAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one hour
Secondary outcomes (3)
Average scores of pain between the both groups: pictorial VAS versus usual VAS
pain score
Measured: one hour
Analgesic treatment between the both groups : pictorial VAS versus usual VAS
analgesic treatment
Measured: one hour
Pain score and analgesic treatment before and after French Sign Language (FSL) explanations
pain score and analgesic treatment
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DeafnessStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoit Mongourdin, PH, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423409
- Sponsor's protocol ID
- EVA SOURD study
- Acronym
- EVA_SOURD
- Status last verified
- Apr 2013
- First submitted
- 22 Jul 2011
- Last updated
- 23 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dagron J. [Deafness and recourse to help, starting the dialog]. Soins. 2001 Dec;(661):37-9. No abstract available. French.
PubMed 12012932Dagron J .Les silencieux. Chroniques de vingt ans de médecine avec les Sourds. Editions : Presse Pluriel, Paris. 2008 ; 287 p.
Delaporte Y. Chapitre 1 : Qui sont les Sourds, histoire d'un mot. In : Les Sourds, c'est comme ça. Editions de la Maison des sciences de l'homme, Paris 2002 ; 398 p.
Gillot Dominique. Le Droit des Sourds. Juin 1998. (mis en ligne le date : http://www.sante.gouv.fr/).
Loi n°2005-102 du 11 février 2005. Pour l'égalité des droits et des chances, la participation et la citoyenneté des personnes handicapées.
Circulaire ministérielle n°DHOS/E1/DGS/SD1B/SD1C/SD4A/2006/90 du 2 mars 2006. La Charte de la personne hospitalisée.
Circulaire N°99-84 du 11.02.1999. (Relative à la mise en place de protocole de prise en charge de la douleur).
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of an Innovative Visual Analogue Scale of Pain (Pictorial VAS) Versus the Usual VAS (VAS) Among Deaf People
- ClinicalTrials.gov ID
- NCT01423409
- Acronym / sponsor ID
- EVA_SOURD / EVA SOURD study
- Conditions
- Deafness, Visual Analog Pain Scale
- Keywords
- visual analog pain scale, Deaf persons, clinical trial, multicentric
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 25 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pictorial VAS | Active comparator | Device: pictorial VASVAS with colours and 6 expressive faces |
| usual VAS | Sham comparator | Device: usual VASVAS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- people aged over 18 years old
- Deaf people
- affiliation to the french social security system or equivalent
- people who signed the consent form
Key exclusion criteria (5 listed)
- hearing people
- people who became deaf
- pregnant or breastfeeding women
- people deprived of freedom
- people hospitalized without consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pictorial VASPictorial VAS includes elements which promote understanding of Deaf people: colours and 6 detailed expressive faces. | Device | pictorial VAS |
| usual VASusual visual analog scale (VAS) of pain (line from 0: no pain to 10:worst pain) | Device | usual VAS |
Primary outcome
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
3 secondary outcomes
Average scores of pain between the both groups: pictorial VAS versus usual VAS
Time frame: one hour
Analgesic treatment between the both groups : pictorial VAS versus usual VAS
Time frame: one hour
Pain score and analgesic treatment before and after French Sign Language (FSL) explanations
Time frame: one hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2013.
- Background: PubMed 12012932Dagron J. [Deafness and recourse to help, starting the dialog]. Soins. 2001 Dec;(661):37-9. No abstract available. French.
- BackgroundDagron J .Les silencieux. Chroniques de vingt ans de médecine avec les Sourds. Editions : Presse Pluriel, Paris. 2008 ; 287 p.
- BackgroundDelaporte Y. Chapitre 1 : Qui sont les Sourds, histoire d'un mot. In : Les Sourds, c'est comme ça. Editions de la Maison des sciences de l'homme, Paris 2002 ; 398 p.
- BackgroundGillot Dominique. Le Droit des Sourds. Juin 1998. (mis en ligne le date : http://www.sante.gouv.fr/).
- BackgroundLoi n°2005-102 du 11 février 2005. Pour l'égalité des droits et des chances, la participation et la citoyenneté des personnes handicapées.
- BackgroundCirculaire ministérielle n°DHOS/E1/DGS/SD1B/SD1C/SD4A/2006/90 du 2 mars 2006. La Charte de la personne hospitalisée.
- BackgroundCirculaire N°99-84 du 11.02.1999. (Relative à la mise en place de protocole de prise en charge de la douleur).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benoit Mongourdin, PH principal investigator
University Hospital, Grenoble
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing pictorial VAS and usual VAS in people with Deafness and Visual Analog Pain Scale, run by University Hospital, Grenoble at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Innovative Visual Analogue Scale of Pain (Pictorial VAS) Versus the Usual VAS (VAS) Among Deaf People (time frame: one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01423409, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2013.