Tenaculum in Endometrial Sampling Procedure

Cukurova University115 enrolled

Overview

Most of gynecological office procedure such as endometrial sampling procedure, hysterosalpingography, hysteroscopy, insertion of contraceptive intrauterine device, difficult intrauterine insemination or embryo transfer procedures often require the application of a single tooth tenaculum to the cervix for steady the cervix, straighten the cervicouterine angle and provide countertraction. However, grasping the cervix with a tenaculum can be a painful experience for the patient.A randomized controlled trial was conducted to evaluate using of tenaculum on pain perception of the patients and the procedure performance of the surgeons in endometrial sampling procedure(ESP) with pipelle.

One hundred fifteen patients included for assessing pain perception and procedure performance during endometrial with pipelle. Patients were randomly assigned to one of two groups as Group 1( with tenaculum) and Group 2 (without tenaculum).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

115

Conditions

Endometrium Biopsy

Interventions

TenaculumDEVICE

Single tooth tenaculum are use to the cervix for steady the cervix, straighten the cervicouterine angle and provide countertraction. Most of gynecological office procedure such as endometrial sampling procedure, hysterosalpingography, hysteroscopy, insertion of contraceptive intrauterine device, difficult intrauterine insemination or embryo transfer procedures often require the application of a tenaculum.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18-80 years old * The women has required endometrial sampling procedure in gynecology outpatients clinic. * Who are capable understand the spoken words and describe the pain. Exclusion Criteria: * Stenotic cervical canal * They had acute cervicitis * Intense anxiety * Need for coincident endocervical curettage * Need for general anesthesia or local anesthetics * The use of analgesic drug pre-procedure * Known history of malignancy * Uterine anomalies or leiomyomas that distort the cervical canal and cavity * A history of failed office endometrial sampling * Positive β-HCG test.

Outcomes

Primary Outcomes

Visual Analog Scala for patient's pain perception

VAS performed four times each patient.

Time frame: 5 second

Secondary Outcomes

Likert scala for procedure performance

Likert scaled one times by the physician.