The Effect of the Valsalva Maneuver in Endometrial Biopsy: A Randomized Controlled Trial

Официальное название

The Effect of the Valsalva Maneuver on Pain and Procedure Success in Endometrial Biopsy: A Randomized Controlled Trial

Обзор

Endometrial sampling with a pipelle is a common procedure used to collect a small sample from the lining of the uterus. During the procedure, the cervix is sometimes held with a surgical instrument called a tenaculum, which may cause pain and anxiety for some women. The Valsalva maneuver is a simple technique in which a person takes a deep breath and pushes as if trying to exhale forcefully. This increases pressure inside the abdomen and may help keep the uterus and cervix more stable during the procedure. This study aims to compare pipelle sampling performed with the Valsalva maneuver to the standard method using a tenaculum. The study will evaluate whether the Valsalva maneuver can reduce pain and anxiety while maintaining procedure success and improving patient satisfaction.

Подробное описание

Endometrial sampling using a pipelle device is a widely used, minimally invasive procedure for the evaluation of abnormal uterine bleeding and other endometrial pathologies. In the conventional technique, cervical traction with a tenaculum is often used to stabilize the cervix and facilitate insertion of the pipelle catheter. However, the use of a tenaculum may increase procedure-related pain and anxiety.

The Valsalva maneuver increases intra-abdominal pressure and may provide temporary stabilization of the uterus and cervix. This physiological effect may facilitate pipelle insertion without the need for cervical traction. Eliminating the use of a tenaculum may reduce patient discomfort and anxiety during the procedure.

This study is designed to compare pipelle endometrial sampling performed with the Valsalva maneuver and the conventional method using a tenaculum. The primary objectives are to evaluate pain perception during the procedure and procedure success. Secondary outcomes include patient anxiety and overall patient satisfaction.

Вмешательства

• Процедура endometrial biopsy
  Endometrial sampling performed using a pipelle cannula.
• Процедура Tenaculum Application
  Application of a tenaculum to the cervix to stabilize it during endometrial biopsy.
• Процедура Valsalva Maneuver
  Patients perform the Valsalva maneuver during endometrial biopsy to reduce perceived pain.

Первичные конечные точки

• Visual Analog Scale(VAS) scores [Срок оценки: Baseline, immediately before the procedure, intra-procedural, and 15 minutes post-procedure]

Вторичные конечные точки (1)

• Procedure Success and Patient Satisfaction [Срок оценки: Up to 15 minutes]

Критерии участия

Критерии включения

-Endometrial sampling indication in reproductive age group of patients over 18 years of age, who can communicate in Turkish.

Критерии исключения

• Patients under 18 years of age - postmenopausal
• Pregnancy
• Patients with known stenotic cervical os
• Patients with a history of acute cervicitis;
• Patients with intense anxiety;
• Need for simultaneous endocervical curettage;
• Need for general or local anesthesia
• Having used analgesic medication before the procedure;
• History of a known malignancy, uterine anomaly, or leiomyoma affecting the cervical canal or uterine cavity, or uterine prolapse;
• Patients with known chronic plevic pain

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

Turkey (Türkiye) · 1 центр

• Cemil Tascioglu City Hospital — Istanbul

Идентификаторы

NCT: NCT07496905 · CemiltascıogluERHO-420

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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