Biopsy Size and Pain Perception During Colposcopic Biopsy

Pain Uterus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03279666
• Other study ID #: 2017/47
• Status: Completed
• Phase: N/A
• Start date: June 15, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: June 2018
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: December 31, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain Uterus
• Tenaculum

Intervention

Other:
• Tenaculum replacement
Tenaculum replacement during colposcopic biopsy

Locations

Country	Name	City	State
Turkey	Cihan Comba	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients' Biopsy Sizes	Are patients' biopsy sizes associate with tenaculum. Milimeter will be used for biopsy size.	6 months
Primary	Patients' Biopsy Sizes	Are patients' biopsy sizes associate with analgesic. Milimeter will be used for biopsy size.	6 months
Secondary	Patients' pain perceptions	Are patients' pain perceptions associate with analgesic. Linear Visual Analog Scale will be used for pain perception.	6 months analgesic
Secondary	Patients' pain perceptions	Are patients' pain perceptions associate with teanaculum. Linear Visual Analog Scale will be used for pain perception.	6 months