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ISRCTN
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ISRCTN71172551
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ClinicalTrials.gov identifier
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Public title
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An evaluation of the self-use of bulb syringes for the self-treatment of ear wax and their impact on primary care workload - a randomised controlled trial
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Scientific title
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Acronym
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Bulb syringe study
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Serial number at source
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N/A
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Study hypothesis
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Ear wax is a commonly presenting problem in primary care. It is surprisingly under-researched and as background to this study we have previously undertaken two pilot studies - a questionnaire study and a feasibility study.
Ear wax is commonly treated by syringing the ear and syringing has been shown to improve hearing and symptoms. However, most GPs have increasingly delegated managing ear wax to practice nurses. The annual salary costs of practice nurses undertaking ear syringing in UK general practice have been estimated at about £8 million. Could that time be better spent? Achieving current NHS targets (such as the New GP Contract) has significant workload implications. Patients do not like delays associated with treating ear wax and patients, GPs and practice nurses would like to encourage such self-help. In some countries plastic bulb syringes with which to irrigate the ear are widely available. Such devices could potentially be marketed in the UK. Their availability in the UK and evidence of their effectiveness and safety could both reduce demands on health service resources and satisfy patients' demands for rapid relief of symptoms. Preliminary results of the pilot study suggest bulb syringes are effective, safe and acceptable to patients.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Ear wax
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Participants - inclusion criteria
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Adults presenting at participating surgeries with symptoms of ear wax and having wax occluding one or both ear drums.
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Participants - exclusion criteria
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History of perforated ear drum, other significant ear disease or surgery, signs of perforation or infection in the affected ear, patients with cognitive impairment sufficient to preclude them from following the instructions or completing the questionnaire.
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Anticipated start date
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01/02/2004
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Anticipated end date
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31/01/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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236
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Interventions
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Self-treatment using a bulb syringe compared with the standard treatment of syringing by a practice nurse or GP.
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Primary outcome measure(s)
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1. Objective clearance of wax
2. Relief of symptoms
3. Acceptability of treatment
4. Unwanted effects of treatment
5. Proportion of people requiring further intervention within 6 weeks
6. Costs of prescriptions for subsequent ear care in 6 weeks from randomisation
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Secondary outcome measure(s)
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Rates of consultation with GP and practice nurse for ear care at one and two years.
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Sources of funding
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Royal College of General Practitioners Scientific Foundation Board, SFB/2003/32 (UK)
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Trial website
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Publications
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1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18186996
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21403136
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Contact name
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Dr
Richard
Coppin
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Address
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Overton Surgery
Station Road
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City/town
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Overton
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Zip/Postcode
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RG25 3DZ
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Country
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United Kingdom
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Tel
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+44 (0)1256 770600
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Fax
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+44 (0)1256 771581
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Email
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overtonsurgery@dial.pipex.com
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Sponsor
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University of Southampton (UK)
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Address
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Research Support Office
Building 37
Room 4033
University of Southampton
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City/town
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Southampton
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Zip/Postcode
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SO17 1BJ
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Country
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United Kingdom
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Sponsor website:
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http://www.soton.ac.uk
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Date applied
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07/09/2005
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Last edited
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18/07/2011
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Date ISRCTN assigned
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29/09/2005
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