Evaluating Pain and Discomfort Associated With Cervical Punch Biopsy

May 18, 2014 updated by: Efraim Siegler, Carmel Medical Center
The use of forced coughing during cervical punch biopsy may reduce pain & discomfort associated with the procedure.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Pain and anxiety are associated with many medical procedures performed in ambulatory setting. Colposcopically guided punch biopsies are a standard procedure performed in women with abnormal cervical cytology, as a part of the diagnosis and treatment selection.

Coughing is thought to provide a distraction and to cause a momentarily increase in blood pressure, reducing pain perception.

Therefore, the present study is designed to compare pain associated with cervical punch biopsy and the effect of forced coughing on pain and pain perception.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 3436212
        • Recruiting
        • Carmel Medical Center
        • Contact:
        • Principal Investigator:
          • Efraim . Siegler, MD
      • Haifa, Israel, 3515209
        • Recruiting
        • Lin Medical Center
        • Contact:
        • Principal Investigator:
          • Efraim . Siegler, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

- Women undergoing cervical punch biopsy

Exclusion Criteria:

  • Women under 18 years old
  • Women currently taking prescription pain medications
  • Women who consumed pain medication up to 2 hours prior to the scheduled biopsy.
  • Women who refuse to take part in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No coughing
Cervical punch biopsy without forced coughing intervention
Experimental: coughing
Forced coughing during cervical punch biopsy
Behavioral: Forced coughing during cervical punch biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The pain associated with cervical biopsy
Time Frame: 10 minutes
Evaluating pain during cervical punch biopsy using VAS 0-10 scale.
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of cervical punch biopsy with and without cough intervention
Time Frame: 10 minutes
Measurement of procedure length in minutes
10 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of biopsies taken in a single session
Time Frame: 12 minutes
During the examination, 1 to 3 cervical punch biopsies will be taken, according to colposcopic cervical appearance.
12 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carmel Medical Center

Collaborators

THERE ARE NO FUNDING SOURCES TO THE STUDY.

Investigators

  • Principal Investigator: Efraim Siegler, MD, Carmel Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

June 9, 2013

First Submitted That Met QC Criteria

June 10, 2013

First Posted (Estimate)

June 12, 2013

Study Record Updates

Last Update Posted (Estimate)

May 20, 2014

Last Update Submitted That Met QC Criteria

May 18, 2014

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CMC-13-0033-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Forced coughing during cervical punch biopsy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe