The main objective of this study is to determine a pointprevalence of otitis externa. Further, we want to determine the presence of risk factors and to obtain information about how otitis externa is presented by people with an intellectual…
ID
Source
Brief title
Condition
- Aural disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameters are the point prevalence of otitis externa and the
presence of risk factors.
Secondary outcome
Secundary outcome are the presented symptoms of otitis externa.
Background summary
Otitis externa is a diffuse inflammation of the skin of external auditory
canal. It can cause symptoms like pain, itching and discharge and sometimes
(conductive) hearing loss. Otitis externa is an acute condition, but can also
be a chronic problem, when the duration exceeds minimum four weeks or when more
than four episodes occur in one year.
A break in the normal protective barrier of the external ear canal can lead to
a disruption of local flora giving other micro-organisms a chance to invade and
grow causing an infection.
Factors like excessive presence of cerumen leading to obstruction of the ear
canal or trauma to the external ear canal, can lead to a break in the
protective barrier of the external ear canal . A narrow external ear canal is
prone to obstruction and therefore also a risk factor to develop otitis externa.
People with an intellectual disability appear to have a higher prevalence of
ear problems, amongst others otitis externa. Also, these people are not always
capable to report earproblems. A search in literature databases Medline and
Embase does not lead to any article reporting about otitis externa in people
with intellectual disabilities. Therefore, we want to investigate the point
prevalence of otitis externa in people with intellectual disabilities. Further,
we want to investigate which risk factors are present and if carers recognised
this condition among their clients.
Study objective
The main objective of this study is to determine a pointprevalence of otitis
externa. Further, we want to determine the presence of risk factors and to
obtain information about how otitis externa is presented by people with an
intellectual disability. Therefore, we formulated the following study questions:
1. What is the (point)prevalence of otitis externa in adults with an
intellectual disability, who are living within an organization for people with
intellectual disabilities?
2. Which risk factors are most common?
2a. Are these factors correlated?
3. Did carers of the participants recognise symptoms, when they appear to
have an otitis externa at the moment of otoscopic investigation?
3a. What are these symptoms?
Study design
This study is observational and descriptive.
Study burden and risks
This study has to be performed among people with an intellectual disability in
order to be able to determine a pointprevalence and risk factors of otitis
externa in this population. This information can enhance consciousness of this
problem in doctors and guardians and therefore lead to a better management of
recurrent infections of the external ear canal
The nature and extent of the burden of this study for the participants is
minimal because many of them already receive an otoscopic examination
regularly. The risks of the otoscopic examination, like damaging the skin of
the external ear canal, are very rare.
When a participant shows physical or verbal resistance to the otoscopic
examination or says that he or she doesn*t want to participate anymore, this
will be respected.
The study will be performed in observation of the Dutch law of medical research
with people, the consensus guideline considering ethics in medical research
among people with an intellectual disability of the NVAVG, and the privacy
legislation. Data will be anonymously reported.
Molenstraat 71
6116 CC Roosteren
NL
Molenstraat 71
6116 CC Roosteren
NL
Listed location countries
Age
Inclusion criteria
older than 18 years, having an intellctual disability, living within an organization for people with intellectual disabilities
Exclusion criteria
atresia of the external ear canal
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL31375.078.10 |