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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1(With Tenaculum) | Active Comparator | This group consisted of the patients whose had been applied tenaculum at cervix during the endometrial sampling procedure |
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| Group 2 (Without Tenaculum) | No Intervention | This group consisted of the patients whose had been not applied tenaculum during the endometrial sampling procedure. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenaculum | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scala for patient's pain perception | VAS performed four times each patient. | 5 second |
| Measure | Description | Time Frame |
|---|---|---|
| Likert scala for procedure performance | Likert scaled one times by the physician. | 5 second |
| Success rate as adequate sampling of endometrial tissue for histopathologic diagnosis. | 5-10 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmet Baris Guzel, Assist Prof Dr. | Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology | Principal Investigator |
| Aybala Kubat, MD | Şahinbey Goverment Hospital | Principal Investigator |
| Ghanim Khatib, MD | Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology | Principal Investigator |
| Fatma Tuncay Ozgunen, Prof Dr. | Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology | Principal Investigator |
| Ibrahim Ferhat Urunsak, Assist Prof Dr. | Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology | Principal Investigator |
| Umran Kucukgoz Gulec, Assist Prof Dr. | Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cukurova University Faculty of Medicine | Adana | 01330 | Turkey (Türkiye) |
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