NCT03279666

Brief Summary

The investigators will investigate patients pain and biopsy size during colposcopic biopsy. The investigators will use tenaculum randomized patient with or without intracervical blockage.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
236

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 15, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

June 8, 2018

Status Verified

June 1, 2018

Enrollment Period

6 months

First QC Date

August 16, 2017

Last Update Submit

June 7, 2018

Conditions

Pain UterusTenaculum

Outcome Measures

Primary Outcomes (2)

  • Patients' Biopsy Sizes

    Are patients' biopsy sizes associate with tenaculum. Milimeter will be used for biopsy size.

    6 months

  • Patients' Biopsy Sizes

    Are patients' biopsy sizes associate with analgesic. Milimeter will be used for biopsy size.

    6 months

Secondary Outcomes (2)

  • Patients' pain perceptions

    6 months analgesic

  • Patients' pain perceptions

    6 months

Study Arms (4)

tenaculum with intracervical blockage

ACTIVE COMPARATOR
Other: Tenaculum replacement

No tenaculum with intracercical blockage

NO INTERVENTION

Tenaculum without intracervical blockage

ACTIVE COMPARATOR
Other: Tenaculum replacement

No Tenaculum without intracervical blockage

NO INTERVENTION

Interventions

Tenaculum replacementOTHER

Tenaculum replacement during colposcopic biopsy

Tenaculum without intracervical blockagetenaculum with intracervical blockage

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • year-old women who had colposcopic biopsy

You may not qualify if:

  • Had orthopedical problems
  • Analgesic allergy
  • Have previous cone biopsy
  • Analgesic use until six hours before colposcopy
  • Advanced cervicovaginal atrophy
  • Linear Visual Analog Score for pain is used

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cihan Comba

Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (1)

  • Comba C, Demirayak G, Erdogan SV, Karaca I, Demir O, Guler O, Ozdemir IA. Comparison of pain and proper sample status according to usage of tenaculum and analgesia: a randomized clinical trial. Obstet Gynecol Sci. 2020 Jul;63(4):506-513. doi: 10.5468/ogs.19185. Epub 2020 Jun 19.

    PMID: 32550738DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2017

First Posted

September 12, 2017

Study Start

June 15, 2017

Primary Completion

November 30, 2017

Study Completion

December 31, 2017

Last Updated

June 8, 2018

Record last verified: 2018-06

Locations

TU(1)