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ISRCTN
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ISRCTN50938901
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ClinicalTrials.gov identifier
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Public title
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How painful is a urethral swab?
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Scientific title
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How painful is a urethral swab? A single centre, randomised controlled trial.
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Acronym
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N/A
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Serial number at source
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RD-5103-012-07
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Study hypothesis
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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.
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Ethics approval
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Derbyshire Research Ethics Committee (REC) approved on the 3rd of March 2008 (ref: 07/H0401/158)
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Study design
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Single centre 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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Genito-urinary medicine
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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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
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Anticipated start date
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19/05/2008
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Anticipated end date
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19/11/2008
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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121
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Interventions
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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
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Primary outcome measure(s)
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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)
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Secondary outcome measure(s)
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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.
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Sources of funding
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Derby Hospitals NHS Foundation Trust (UK)
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Trial website
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Publications
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Contact name
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Dr
Ade
Apoola
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Address
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Derby Hospitals NHS Foundation Trust
London Road Community Hospital
Genito-Urinary Department
London Road
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City/town
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Derby
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Zip/Postcode
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DE1 2QY
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Country
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United Kingdom
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Sponsor
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Derby Hospitals NHS Foundation Trust (UK)
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Address
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Royal Derby Hospital
Uttoxeter Road
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City/town
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Derby
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Zip/Postcode
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DE22 3NE
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Country
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United Kingdom
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Tel
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+44 (0)1332 340131
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Email
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teresa.grieve@derbyhospitals.nhs.uk
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Sponsor website:
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http://www.derbyhospitals.nhs.uk/
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Date applied
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27/11/2009
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Last edited
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27/01/2010
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Date ISRCTN assigned
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27/01/2010
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