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Biopsy Size and Pain Perception During Colposcopic Biopsy

A Randomized Controlled Study: Patients' With or Without Tenaculum Placement and Intracervical Blockage/or Not During Colposcopic Biopsy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03279666
Enrollment
236
Registered
2017-09-12
Start date
2017-06-15
Completion date
2017-12-31
Last updated
2018-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Uterus, Tenaculum

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.

Detailed description

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.

Interventions

OTHERTenaculum replacement

Tenaculum replacement during colposcopic biopsy

Sponsors

Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patients' Biopsy Sizes6 monthsAre patients' biopsy sizes associate with tenaculum. Milimeter will be used for biopsy size.

Secondary

MeasureTime frameDescription
Patients' pain perceptions6 months analgesicAre patients' pain perceptions associate with analgesic. Linear Visual Analog Scale will be used for pain perception.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026