Biopsy Size and Pain Perception During Colposcopic Biopsy

June 7, 2018 updated by: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

A Randomized Controlled Study: Patients' With or Without Tenaculum Placement and Intracervical Blockage/or Not During Colposcopic Biopsy

The investigators will investigate patients pain and biopsy size during colposcopic biopsy. The investigators will use tenaculum randomized patient with or without intracervical blockage.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was designed four arms. The investigators will perform colposcopy because of various causes. The first arm is used tenaculum and performed intracervical blockage. The second arm is not used tenaculum and performed intracervical blockage. The third arm is used tenaculum and not performed intracervical blockage. The fourth arm is not used tenaculum and not performed intracervical blockage and then we will study patients pain and biopsy size during colposcopic biopsy. Pain reduce and biopsy size are very important for patient and diagnose of the cervix cancer.

Study Type

Interventional

Enrollment (Actual)

236

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

  • Turkey
      • İstanbul, Turkey, 34000
        • Cihan Comba

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 18-80 year-old women who had colposcopic biopsy

Exclusion Criteria:

  • Had orthopedical problems
  • Analgesic allergy
  • Have previous cone biopsy
  • Analgesic use until six hours before colposcopy
  • Advanced cervicovaginal atrophy
  • Linear Visual Analog Score for pain is used

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: tenaculum with intracervical blockage
Other: Tenaculum replacement
Tenaculum replacement during colposcopic biopsy
No Intervention: No tenaculum with intracercical blockage
Active Comparator: Tenaculum without intracervical blockage
Other: Tenaculum replacement
Tenaculum replacement during colposcopic biopsy
No Intervention: No Tenaculum without intracervical blockage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients' Biopsy Sizes
Time Frame: 6 months
Are patients' biopsy sizes associate with tenaculum. Milimeter will be used for biopsy size.
6 months
Patients' Biopsy Sizes
Time Frame: 6 months
Are patients' biopsy sizes associate with analgesic. Milimeter will be used for biopsy size.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients' pain perceptions
Time Frame: 6 months analgesic
Are patients' pain perceptions associate with analgesic. Linear Visual Analog Scale will be used for pain perception.
6 months analgesic
Patients' pain perceptions
Time Frame: 6 months
Are patients' pain perceptions associate with teanaculum. Linear Visual Analog Scale will be used for pain perception.
6 months

Collaborators and Investigators

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

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

June 15, 2017

Primary Completion (Actual)

November 30, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

August 16, 2017

First Submitted That Met QC Criteria

September 11, 2017

First Posted (Actual)

September 12, 2017

Study Record Updates

Last Update Posted (Actual)

June 8, 2018

Last Update Submitted That Met QC Criteria

June 7, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 2017/47

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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