RecruitingNot ApplicableNCT07496905

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

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


Sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Enrollment

120 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 55 Years

Inclusion Criteria1

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

Exclusion Criteria10

  • 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

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Interventions

PROCEDUREendometrial biopsy

Endometrial sampling performed using a pipelle cannula.

PROCEDURETenaculum Application

Application of a tenaculum to the cervix to stabilize it during endometrial biopsy.

PROCEDUREValsalva Maneuver

Patients perform the Valsalva maneuver during endometrial biopsy to reduce perceived pain.


Locations(1)

Cemil Tascioglu City Hospital

Istanbul, Turkey (Türkiye)

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NCT07496905


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