Actively Recruiting

Phase Not Applicable
Age: 18Years - 55Years
FEMALE
Healthy Volunteers
ID07496905

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

Led by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization · Updated on 2026-03-27

120

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research investigates the use of the Valsalva maneuver during endometrial biopsy to compare it with the standard method using a tenaculum. The study focuses on women experiencing abnormal uterine bleeding or other endometrial conditions who require sampling of the uterine lining. It aims to determine if the Valsalva maneuver reduces pain and anxiety while maintaining the procedure's success and improving patient satisfaction. Participants undergo an endometrial biopsy using a pipelle cannula. They are randomly assigned to either have the procedure done with a tenaculum holding the cervix or while performing the Valsalva maneuver, which involves taking a deep breath and pushing as if exhaling forcefully to stabilize the uterus and cervix. The study compares these two methods to evaluate pain and procedure success. During the study, pain is measured using a Visual Analog Scale at baseline, immediately before the procedure, during the procedure, and 15 minutes after. Researchers also assess procedure success, patient anxiety, and satisfaction up to 15 minutes post-procedure. Participants are women aged 18 to 55 who can communicate in Turkish, and the trial includes safety and effectiveness monitoring throughout the process.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 55Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women over 18 years old in the reproductive age group
  • Indicated for endometrial sampling
  • Able to communicate in Turkish
Not Eligible

You will not qualify if you...

  • Under 18 years old or postmenopausal
  • Pregnant
  • Known stenotic cervical os
  • History of acute cervicitis
  • Intense anxiety
  • Need for simultaneous endocervical curettage
  • Need for general or local anesthesia
  • Used analgesic medication before the procedure
  • History of known malignancy, uterine anomaly, leiomyoma affecting cervical canal or uterine cavity, or uterine prolapse
  • Known chronic pelvic pain

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single procedure visit

Participants undergo an endometrial biopsy using a pipelle cannula. They are assigned to either the Valsalva maneuver group, performing the maneuver during the procedure, or the tenaculum group, where a tenaculum is applied to stabilize the cervix.

1 procedure visit (in-person)

Follow-up

Duration - Up to 15 minutes post-procedure

Participants are observed for procedure success, pain perception, anxiety, and overall satisfaction following the biopsy procedure.

1 post-procedure assessment (in-person)

Trial Site Locations

Total: 1 location

1

Cemil Tascioglu City Hospital

Istanbul, Turkey (Türkiye)

Actively Recruiting

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Research Team

N

Neslihan Doctor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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