ClinicalTrials.gov
ClinicalTrials.gov Menu

Biopsy Size and Pain Perception During Colposcopic Biopsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03279666
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

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

Condition or disease Intervention/treatment Phase
Pain Uterus Tenaculum Other: Tenaculum replacement Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: A Randomized Controlled Study: Patients' With or Without Tenaculum Placement and Intracervical Blockage/or Not During Colposcopic Biopsy
Actual Study Start Date : June 15, 2017
Estimated Primary Completion Date : November 30, 2017
Estimated Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Patients' Biopsy Sizes [ Time Frame: 6 months ]
    Are patients' biopsy sizes associate with tenaculum. Milimeter will be used for biopsy size.

  2. Patients' Biopsy Sizes [ Time Frame: 6 months ]
    Are patients' biopsy sizes associate with analgesic. Milimeter will be used for biopsy size.


Secondary Outcome Measures :
  1. 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.

  2. Patients' pain perceptions [ Time Frame: 6 months ]
    Are patients' pain perceptions associate with teanaculum. Linear Visual Analog Scale will be used for pain perception.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279666


Contacts
Contact: Cihan Comba +905054735363 comba.cihan@yahoo.com.tr

Locations
Turkey
Cihan Comba Recruiting
İstanbul, Turkey, 34000
Contact: Cihan Comba       comba.cihan@yahoo.com.tr   
Sponsors and Collaborators
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Responsible Party: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
ClinicalTrials.gov Identifier: NCT03279666     History of Changes
Other Study ID Numbers: 2017/47
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No