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

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Status: Enrolling

Conditions: Pain in Endometrial Biopsy; Abnormal Uterine Bleeding

Treatments: Procedure: endometrial biopsy; Procedure: Tenaculum Application; Procedure: Valsalva Maneuver

Study type: Interventional

Funder types: Other

Identifiers

NCT07496905

CemiltascıogluERHO-420

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

120 participants in 2 patient groups

Tenaculum Group

Active Comparator group

Description:

Patients undergo endometrial biopsy using a pipelle cannula, either with the application of a tenaculum or while performing the Valsalva maneuver.

Treatment:

Procedure: Tenaculum Application

Procedure: endometrial biopsy

Valsalva Maneuver Group

Active Comparator group

Description:

Patients perform the Valsalva maneuver during endometrial biopsy using a pipelle cannula.

Treatment:

Procedure: Valsalva Maneuver

Procedure: endometrial biopsy