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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Overton Surgery
Station Road
Overton
RG25 3DZ
United Kingdom
| Phone | +44 (0)1256 770600 |
|---|---|
| overtonsurgery@dial.pipex.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 measures | Rates of consultation with GP and practice nurse for ear care at one and two years. |
| Overall study start date | 01/02/2004 |
| Completion date | 31/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Overton Surgery
Overton
RG25 3DZ
United Kingdom
RG25 3DZ
United Kingdom
Sponsor information
University of Southampton (UK)
University/education
University/education
Research Support Office
Building 37
Room 4033
University of Southampton
Southampton
SO17 1BJ
England
United Kingdom
| Website | http://www.soton.ac.uk |
|---|---|
"ROR" |
https://ror.org/01ryk1543 |
Funders
Funder type
University/education
Royal College of General Practitioners Scientific Foundation Board, SFB/2003/32 (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
