NCT01876225

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable pain

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 20, 2014

Status Verified

June 1, 2013

Enrollment Period

2 years

First QC Date

June 9, 2013

Last Update Submit

May 18, 2014

Conditions

PainAnxiety

Keywords

cervical biopsyforced coughpainVAS scale

Outcome Measures

Primary Outcomes (1)

  • The pain associated with cervical biopsy

    Evaluating pain during cervical punch biopsy using VAS 0-10 scale.

    10 minutes

Secondary Outcomes (1)

  • Length of cervical punch biopsy with and without cough intervention

    10 minutes

Other Outcomes (1)

  • Number of biopsies taken in a single session

    12 minutes

Study Arms (2)

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

Forced coughing during cervical punch biopsyBEHAVIORAL
coughing

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Women undergoing cervical punch biopsy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Carmel Medical Center

Haifa, 3436212, Israel

RECRUITING

Lin Medical Center

Haifa, 3515209, Israel

RECRUITING

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Efraim Siegler, MD

    Carmel Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Efraim siegler, MD

CONTACT

972-4-8568486hfefraimsi@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Cervical Clinic

Study Record Dates

First Submitted

June 9, 2013

First Posted

June 12, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2016

Last Updated

May 20, 2014

Record last verified: 2013-06

Locations

IL(2)