How painful is a urethral swab?
| ISRCTN | ISRCTN50938901 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50938901 |
| Secondary identifying numbers | RD-5103-012-07 |
- Submission date
- 27/11/2009
- Registration date
- 27/01/2010
- Last edited
- 04/07/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Ade Apoola
Scientific
Scientific
Derby Hospitals NHS Foundation Trust
London Road Community Hospital
Genito-Urinary Department
London Road
Derby
DE1 2QY
United Kingdom
Study information
| Study design | Single centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | How painful is a urethral swab? A single centre, randomised controlled trial. |
| Study hypothesis | To investigate the intensity of the discomfort felt during the insertion of the first urethral swab, when different swab types are used. 1. To determine if there is any difference in the discomfort felt during the insertion of the first of three urethral swabs using different types. 2. To investigate the intensity of the discomfort felt during the insertion of the second and the third urethral swab using different types. 3. To determine if there is an association between particular healthcare workers (HCW) and the discomfort experienced during a urethral swab procedure. 4. To assess if previous experience of swab taking in the patient has an effect on the perception of discomfort felt during the procedure. 5. To assess if urethral inflammation affects the discomfort felt during the procedure. |
| Ethics approval(s) | Derbyshire Research Ethics Committee (REC) approved on the 3rd of March 2008 (ref: 07/H0401/158) |
| Condition | Genito-urinary medicine |
| Intervention | Following informed consent, participants will be randomised to receive one of the following types of swab first: 1. To have a gonorrhoea Dacron tipped swab first 2. To have a chlamydia Rayon tipped swab first 3. To have a plastic urethral loop swab first All patients will have the other 2 types of swab taken as routine practice in an order pre-specified by the pre-randomised envelopes. Participants will be given a short questionnaire to complete before the first swab is taken for investigations. Participants will be given a numerical rating scale to measure intensity of discomfort felt after each of the 3 swabs have been taken. All three swabs are routinely taken in clinics in accordance with manufacturers instructions. The duration of the study will be 6 months |
| Intervention type | Other |
| Primary outcome measure | The discomfort felt during urethral swab procedure after the first of 3 different swab types are used, will be assessed using the Visual Analogue Scale (0-100mm) |
| Secondary outcome measures | 1. The discomfort during the procedure using each of the other two types of swab using the Visual Analogue Scale (0-100mm) will be assessed. 2. Data on presence and severity of urethral symptoms prior to swab taking will be collected using the Data Collection form. 3. Data will also be collected on the identity of the HCW taking the swab and the presence of epithelial cells (a marker of an adequately taken swab) and polymorphonuclear cells (a marker of inflammation) in the specimen and voided urine after swabs. |
| Overall study start date | 19/05/2008 |
| Overall study end date | 19/11/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 121 |
| Participant inclusion criteria | All male patients over 16 attending the Genito-Urinary clinic during the study period and having swab tests will be invited to participate in the study. |
| Participant exclusion criteria | 1. Subjects who have passed urine within 2 hours of planned procedure (swab) 2. Subjects who have taken analgesics, anti-depressants or anti-epileptic drugs in the previous 24 hours |
| Recruitment start date | 19/05/2008 |
| Recruitment end date | 19/11/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Derby Hospitals NHS Foundation Trust
Derby
DE1 2QY
United Kingdom
DE1 2QY
United Kingdom
Sponsor information
Derby Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
England
United Kingdom
| Phone | +44 (0)1332 340131 |
|---|---|
| teresa.grieve@derbyhospitals.nhs.uk | |
| Website | http://www.derbyhospitals.nhs.uk/ |
Funders
Funder type
Hospital/treatment centre
Derby Hospitals NHS Foundation Trust (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 | 01/03/2011 | Yes | No |
