Condition category
Surgery
Date applied
05/11/2012
Date assigned
05/03/2013
Last edited
05/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
mari.kiviharju@hus.fi

Trial website

Contact information

Type

Scientific

Primary contact

Dr Pekka Nieminen

ORCID ID

Contact details

Helsinki University Hospital
Bo-BOX 140
Helsinki
00029
Finland

Additional identifiers

EudraCT number

2012-005106-21

ClinicalTrials.gov number

Protocol/serial number

2012-005106-21

Study information

Scientific title

Effect of local anesthesia on pain sensation during colposcopy: a randomized trial

Acronym

Study hypothesis

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.

Ethics approval

Helsinki University Institutional Review Board, 2.10.2012, ref: (292/13/03/03/2012)

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet (in Finnish only)

Condition

Colposcopy: pain during punch biopsies

Intervention

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.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

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

12/11/2012

Overall trial end date

30/05/2013

Reason abandoned

Eligibility

Participant inclusion criteria

All eligible women who have been referred to diagnostic colposcopy for any cytological abnormality

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

200

Participant exclusion criteria

1. Allergy to local anesthesia (prilocain + felypressin)
2. Pregnancy
3. Suspicion of cancer

Recruitment start date

12/11/2012

Recruitment end date

30/05/2013

Locations

Countries of recruitment

Finland

Trial participating centre

Helsinki University Hospital
Helsinki
00029
Finland

Sponsor information

Organisation

Helsinki University Hospital (Finland)

Sponsor details

Bo-BOX 140
Helsinki
00029
Finland

Sponsor type

Hospital/treatment centre

Website

http://www.med.helsinki.fi

Funders

Funder type

University/education

Funder name

Helsinki University Research Foundation (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes