Biopsy Size and Pain Perception During Colposcopic Biopsy

NCT ID: NCT03279666

Last Updated: 2018-06-08

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

COMPLETED

Clinical Phase

NA

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-15

Study Completion Date

2017-12-31

Brief Summary

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

Detailed Description

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The study was designed four arms. The investigators will perform colposcopy because of various causes. The first arm is used tenaculum and performed intracervical blockage. The second arm is not used tenaculum and performed intracervical blockage. The third arm is used tenaculum and not performed intracervical blockage. The fourth arm is not used tenaculum and not performed intracervical blockage and then we will study patients pain and biopsy size during colposcopic biopsy. Pain reduce and biopsy size are very important for patient and diagnose of the cervix cancer.

Conditions

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Pain Uterus Tenaculum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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tenaculum with intracervical blockage

Group Type ACTIVE_COMPARATOR

Tenaculum replacement

Intervention Type OTHER

Tenaculum replacement during colposcopic biopsy

No tenaculum with intracercical blockage

Group Type NO_INTERVENTION

No interventions assigned to this group

Tenaculum without intracervical blockage

Group Type ACTIVE_COMPARATOR

Tenaculum replacement

Intervention Type OTHER

Tenaculum replacement during colposcopic biopsy

No Tenaculum without intracervical blockage

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tenaculum replacement

Tenaculum replacement during colposcopic biopsy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18-80 year-old women who had colposcopic biopsy

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bakirkoy Dr. Sadi Konuk Research and Training Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cihan Comba

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 32550738 (View on PubMed)

Other Identifiers

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2017/47

Identifier Type: -

Identifier Source: org_study_id

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