Evaluating Pain and Discomfort Associated With Cervical Punch Biopsy

NCT ID: NCT01876225

Last Updated: 2014-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Pain Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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No coughing

Cervical punch biopsy without forced coughing intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

coughing

Forced coughing during cervical punch biopsy

Group Type EXPERIMENTAL

Forced coughing during cervical punch biopsy

Intervention Type BEHAVIORAL

Interventions

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Forced coughing during cervical punch biopsy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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THERE ARE NO FUNDING SOURCES TO THE STUDY.

UNKNOWN

Sponsor Role collaborator

Carmel Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Efraim Siegler

Head of Cervical Clinic

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Efraim Siegler, MD

Role: PRINCIPAL_INVESTIGATOR

Carmel Medical Center

Locations

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Carmel Medical Center

Haifa, , Israel

Site Status RECRUITING

Lin Medical Center

Haifa, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Efraim siegler, MD

Role: CONTACT

972-4-8568486

Facility Contacts

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Efraim Siegler, MD

Role: primary

972-4-8568486

Efraim Siegler, MD

Role: primary

972-4-8568486

Other Identifiers

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CMC-13-0033-CTIL

Identifier Type: -

Identifier Source: org_study_id

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