Evaluating Pain and Discomfort Associated With Cervical P... | NCT01876225

Studies
Evaluating Pain and Discomfort Associated With Cervical Punch Biopsy

NCT01876225

Sponsor

Carmel Medical Center

Status

Unknown status

Last Update Posted

May 20, 2014Estimated

Enrollment

90Estimated

Phase

Not Applicable

Conditions

Pain
Anxiety

Interventions

Forced coughing during cervical punch biopsy

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Jun 2015Estimated

Completion Date

Jun 2016Estimated

First Submitted Date

Jun 9, 2013

First Submission Date that Met QC Criteria

Jun 10, 2013

First Posted Date

Jun 12, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2014

Last Update Posted Date

May 20, 2014Estimated

Name	Class
THERE ARE NO FUNDING SOURCES TO THE STUDY.	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No coughing	No Intervention	Cervical punch biopsy without forced coughing intervention
coughing	Experimental	Forced coughing during cervical punch biopsy	Behavioral: Forced coughing during cervical punch biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Forced coughing during cervical punch biopsy	Behavioral		coughing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The pain associated with cervical biopsy	Evaluating pain during cervical punch biopsy using VAS 0-10 scale.	10 minutes

Secondary Outcomes

Measure	Description	Time Frame
Length of cervical punch biopsy with and without cough intervention	Measurement of procedure length in minutes	10 minutes

Other Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Efraim siegler, MD	Contact	972-4-8568486		hfefraimsi@clalit.org.il

Overall Officials

Name	Affiliation	Role
Efraim Siegler, MD	Carmel Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Carmel Medical Center	Recruiting	Haifa		3436212	Israel

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D001008	Anxiety Disorders

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided