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Evaluating Pain and Discomfort Associated With Cervical Punch Biopsy

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ClinicalTrials.gov Identifier: NCT01876225
Recruitment Status : Unknown
Verified June 2013 by Efraim Siegler, Carmel Medical Center.
Recruitment status was:  Recruiting
First Posted : June 12, 2013
Last Update Posted : May 20, 2014
Sponsor:
Collaborator:
THERE ARE NO FUNDING SOURCES TO THE STUDY.
Information provided by (Responsible Party):
Efraim Siegler, Carmel Medical Center

Brief Summary:
The use of forced coughing during cervical punch biopsy may reduce pain & discomfort associated with the procedure.

Condition or disease Intervention/treatment Phase
Pain Anxiety Behavioral: Forced coughing during cervical punch biopsy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluating Pain and Discomfort Associated With Cervical Punch Biopsy
Study Start Date : June 2013
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Cough

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



Primary Outcome Measures :
  1. The pain associated with cervical biopsy [ Time Frame: 10 minutes ]
    Evaluating pain during cervical punch biopsy using VAS 0-10 scale.


Secondary Outcome Measures :
  1. Length of cervical punch biopsy with and without cough intervention [ Time Frame: 10 minutes ]
    Measurement of procedure length in minutes


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01876225


Contacts
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Contact: Efraim siegler, MD 972-4-8568486 hfefraimsi@clalit.org.il

Locations
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Israel
Carmel Medical Center Recruiting
Haifa, Israel, 3436212
Contact: Efraim Siegler, MD    972-4-8568486    hfefraimsi@clalit.org.il   
Principal Investigator: Efraim . Siegler, MD         
Lin Medical Center Recruiting
Haifa, Israel, 3515209
Contact: Efraim Siegler, MD    972-4-8568486    hfefraimsi@clalit.org.il   
Principal Investigator: Efraim . Siegler, MD         
Sponsors and Collaborators
Carmel Medical Center
THERE ARE NO FUNDING SOURCES TO THE STUDY.
Investigators
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Principal Investigator: Efraim Siegler, MD Carmel Medical Center

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Responsible Party: Efraim Siegler, Head of Cervical Clinic, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01876225     History of Changes
Other Study ID Numbers: CMC-13-0033-CTIL
First Posted: June 12, 2013    Key Record Dates
Last Update Posted: May 20, 2014
Last Verified: June 2013

Keywords provided by Efraim Siegler, Carmel Medical Center:
cervical biopsy
forced cough
pain
VAS scale