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

March 23, 2026 updated by: Neslihan Bademler, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tenaculum Group
Patients undergo endometrial biopsy using a pipelle cannula, either with the application of a tenaculum or while performing the Valsalva maneuver.
Procedure: endometrial biopsy
Endometrial sampling performed using a pipelle cannula.
Procedure: Tenaculum Application
Application of a tenaculum to the cervix to stabilize it during endometrial biopsy.
Active Comparator: Valsalva Maneuver Group
Patients perform the Valsalva maneuver during endometrial biopsy using a pipelle cannula.
Procedure: endometrial biopsy
Endometrial sampling performed using a pipelle cannula.
Procedure: Valsalva Maneuver
Patients perform the Valsalva maneuver during endometrial biopsy to reduce perceived pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale(VAS) scores
Time Frame: Baseline, immediately before the procedure, intra-procedural, and 15 minutes post-procedure

Pain will be assessed using a 10-cm Visual Analog Scale (VAS) (0 = no pain; 10 = worst imaginable pain). VAS scores will be recorded at four predefined time points:

The primary endpoint will be the comparison of VAS pain scores between the two groups.
Baseline, immediately before the procedure, intra-procedural, and 15 minutes post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure Success and Patient Satisfaction
Time Frame: Up to 15 minutes
Outcome Measure: Procedure satisfaction Post-procedure, procedure satisfaction will be evaluated using a 5-point Likert scale (1 = very difficult; 5 = very easy). All obtained endometrial samples will be assessed for adequacy and histopathological diagnosis. Procedural failure will be defined as the inability to access the uterine cavity with the Pipelle cannula without cervical dilatation after three attempts.
Up to 15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 16, 2025

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CemiltascıogluERHO-420

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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