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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
DOI 10.1186/ISRCTN71172551
ClinicalTrials.gov identifier
EudraCT number
Public title 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
Scientific title
Acronym Bulb syringe study
Serial number at source N/A
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Ear wax
Participants - inclusion criteria Adults presenting at participating surgeries with symptoms of ear wax and having wax occluding one or both ear drums.
Participants - exclusion criteria 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.
Anticipated start date 01/02/2004
Anticipated end date 31/01/2007
Status of trial Completed
Patient information material
Target number of participants 236
Interventions Self-treatment using a bulb syringe compared with the standard treatment of syringing by a practice nurse or GP.
Primary outcome measure(s) 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
Secondary outcome measure(s) Rates of consultation with GP and practice nurse for ear care at one and two years.
Sources of funding Royal College of General Practitioners Scientific Foundation Board, SFB/2003/32 (UK)
Trial website
Publications 1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18186996
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21403136
Contact name Dr  Richard  Coppin
  Address Overton Surgery
Station Road
  City/town Overton
  Zip/Postcode RG25 3DZ
  Country United Kingdom
  Tel +44 (0)1256 770600
  Fax +44 (0)1256 771581
  Email overtonsurgery@dial.pipex.com
Sponsor University of Southampton (UK)
  Address Research Support Office
Building 37
Room 4033
University of Southampton
  City/town Southampton
  Zip/Postcode SO17 1BJ
  Country United Kingdom
  Sponsor website: http://www.soton.ac.uk
Date applied 07/09/2005
Last edited 18/07/2011
Date ISRCTN assigned 29/09/2005
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