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

ISRCTN	ISRCTN71172551
DOI	https://doi.org/10.1186/ISRCTN71172551
Protocol serial number	N/A
Sponsor	University of Southampton (UK)
Funder	Royal College of General Practitioners Scientific Foundation Board, SFB/2003/32 (UK)

Submission date: 07/09/2005
Registration date: 29/09/2005
Last edited: 18/07/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Ear, Nose and Throat

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Richard Coppin
Scientific

Overton Surgery
Station Road
Overton
RG25 3DZ
United Kingdom

Phone	+44 (0)1256 770600
Email	overtonsurgery@dial.pipex.com

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	Bulb syringe study
Study objectives	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.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Ear wax
Intervention	Self-treatment using a bulb syringe compared with the standard treatment of syringing by a practice nurse or GP.
Intervention type	Other
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
Key secondary outcome measure(s)	Rates of consultation with GP and practice nurse for ear care at one and two years.
Completion date	31/01/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	236
Key inclusion criteria	Adults presenting at participating surgeries with symptoms of ear wax and having wax occluding one or both ear drums.
Key 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.
Date of first enrolment	01/02/2004
Date of final enrolment	31/01/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Overton Surgery

Overton
RG25 3DZ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2008		Yes	No
Results article	results	01/03/2011		Yes	No