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NCT01876225 Clinical Trial

Evaluating Pain and Discomfort Associated With Cervical Punch Biopsy

Pain Clinical Trial

Official title:
Evaluating Pain and Discomfort Associated With Cervical Punch Biopsy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01876225
Other study ID # CMC-13-0033-CTIL
Secondary ID
Status Recruiting
Phase N/A
First received June 9, 2013
Last updated May 18, 2014
Start date June 2013
Est. completion date June 2016

Study information
Verified date June 2013
Source Carmel Medical Center
Contact Efraim siegler, MD
Phone 972-4-8568486
Email hfefraimsi@clalit.org.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 90
Est. completion date June 2016
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Forced coughing during cervical punch biopsy

Locations
Country Name City State
Israel Carmel Medical Center Haifa
Israel Lin Medical Center Haifa

Sponsors (2)
Lead Sponsor Collaborator
Carmel Medical Center THERE ARE NO FUNDING SOURCES TO THE STUDY.

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Other Number of biopsies taken in a single session During the examination, 1 to 3 cervical punch biopsies will be taken, according to colposcopic cervical appearance. 12 minutes No
Primary The pain associated with cervical biopsy Evaluating pain during cervical punch biopsy using VAS 0-10 scale. 10 minutes No
Secondary Length of cervical punch biopsy with and without cough intervention Measurement of procedure length in minutes 10 minutes No
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