Plain English Summary
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
Effect of local anesthesia on pain sensation during colposcopy: a randomized trial
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.
Helsinki University Institutional Review Board, 2.10.2012, ref: (292/13/03/03/2012)
Randomized controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet (in Finnish only)
Colposcopy: pain during punch biopsies
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.
Primary outcome measure
Pain, measured using the Visual Analogue Scale (VAS) score (0 = no pain, 10 = unbearable pain) after punch biopsies.
Secondary outcome measures
1. Abnormal bleeding after colposcopy
2. Beck's anxiety inventory score
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
All eligible women who have been referred to diagnostic colposcopy for any cytological abnormality
Target number of participants
Participant exclusion criteria
1. Allergy to local anesthesia (prilocain + felypressin)
3. Suspicion of cancer
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Helsinki University Hospital
Helsinki University Hospital (Finland)
Helsinki University Research Foundation (Finland)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)