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ISRCTN
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ISRCTN20548888
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DOI
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10.1186/ISRCTN20548888
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ClinicalTrials.gov identifier
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EudraCT number
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2012-005106-21
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Public title
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Effect of local anesthesia on pain sensation during colposcopy
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Scientific title
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Effect of local anesthesia on pain sensation during colposcopy: a randomized trial
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Acronym
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N/A
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Serial number at source
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2012-005106-21
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Study hypothesis
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The main objective is to measure pain by using visual analogy scale (VAS) during colposcopy and biopsies. We hypothesize that local anesthesia will reduce pain and discomfort.
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Lay summary
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Background and study aims
Traditionally colposcopy [is a procedure where the surface of the cervix is closely examined using a magnifying instrument called a colposcope] with punch biopsies [a biopsy that is performed by using a punch, an instrument for cutting and removing a disk of tissue] is performed without any local anesthesia in Finland. We have observed that using local anesthesia reduces pain and discomfort during this treatment.
Who can participate?
Any woman who have been referred to diagnostic colposcopy in Helsinki University Hospital. Only if they have allergy to anesthetic agent, if they are pregnant, or if there is a suspicion of cancer they are not asked to participate in this study.
What does the study involve?
Half of the participants will be randomly allocated to receive local anesthesia before punch biopsies. Other half will be treated without local anesthesia. Pain will be measured by visual analogue scale (VAS). Participants from both groups will be asked to fill in a questionnaire, Beck's anxiety inventory before the treatment.
What are the possible benefits and risks of participating?
The possible benefit is probably less pain during the punch biopsies.
The only additional risk for participating in the study is possible allergy to anaesthetic agent that the subject is not aware of. All the subjects would be treated the same way despite of participating in the study or not.
Where is the study run from?
The study takes place in Helsinki University Hospital, Department of Obsterics and Gynaecology.
When is the study starting and how long is it expected to run for?
The study started in November, 2012 and will last until May 2013.
Who is funding the study?
This study has received funding from Helsinki University Research Foundation.
Who is the main contact?
Dr Mari Kiviharju
mari.kiviharju@hus.fi
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Ethics approval
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Helsinki University Institutional Review Board, 2.10.2012, ref: (292/13/03/03/2012)
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Study design
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Randomized controlled trial
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Countries of recruitment
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Finland
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Disease/condition/study domain
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Colposcopy: pain during punch biopsies
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Participants - inclusion criteria
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All eligible women who have been referred to diagnostic colposcopy for any cytological abnormality
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Participants - exclusion criteria
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1. Allergy to local anesthesia (prilocain + felypressin)
2. Pregnancy
3. Suspicion of cancer
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Anticipated start date
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12/11/2012
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Anticipated end date
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30/05/2013
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Status of trial
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Ongoing |
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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 (in Finnish only)
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Target number of participants
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200
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Interventions
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Woman referred to colposcopy will be randomized into two groups
1. Colposcopy with local anesthesia
2. Colposcopy without local anesthesia
Pain will be measured by VAS scale after biopsies. We will also ask Beck's anxiety inventory for both groups before the treatment.
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Primary outcome measure(s)
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Pain, measured using the Visual Analogue Scale (VAS) score (0 = no pain, 10 = unbearable pain) after punch biopsies.
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Secondary outcome measure(s)
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1. Abnormal bleeding after colposcopy
2. Beck's anxiety inventory score
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Sources of funding
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Helsinki University Research Foundation (Finland)
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Trial website
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Publications
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Contact name
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Dr
Pekka
Nieminen
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Address
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Helsinki University Hospital
Bo-BOX 140
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City/town
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Helsinki
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Zip/Postcode
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00029
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Country
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Finland
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Sponsor
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Helsinki University Hospital (Finland)
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Address
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Bo-BOX 140
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City/town
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Helsinki
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Zip/Postcode
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00029
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Country
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Finland
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Sponsor website:
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http://www.med.helsinki.fi
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Date applied
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05/11/2012
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Last edited
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05/03/2013
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Date ISRCTN assigned
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05/03/2013
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