Biopsy Size and Pain Perception During Colposcopic Biopsy

Study Overview
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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.

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

Conditions
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Pain Uterus, Tenaculum

Intervention / Treatment
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* Other: Tenaculum replacement


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tenaculum with intracervical blockage<br> | Other: Tenaculum replacement<br>* Tenaculum replacement during colposcopic biopsy<br>|
| No Intervention: No tenaculum with intracercical blockage<br> | |
| Active Comparator: Tenaculum without intracervical blockage<br> | Other: Tenaculum replacement<br>* Tenaculum replacement during colposcopic biopsy<br>|
| No Intervention: No Tenaculum without intracervical blockage<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' pain perceptions | Are patients' pain perceptions associate with analgesic. Linear Visual Analog Scale will be used for pain perception. | 6 months analgesic | 
| Patients' pain perceptions | Are patients' pain perceptions associate with teanaculum. Linear Visual Analog Scale will be used for pain perception. | 6 months |