NCT07496905

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Jan 2025Dec 2026

Study Start

First participant enrolled

January 1, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 27, 2026

Status Verified

December 1, 2025

Enrollment Period

1.9 years

First QC Date

December 16, 2025

Last Update Submit

March 23, 2026

Conditions

Pain in Endometrial BiopsyAbnormal Uterine Bleeding

Keywords

endometrial biopsyvalsalva maneuverPain

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale(VAS) scores

    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 Outcomes (1)

  • Procedure Success and Patient Satisfaction

    Up to 15 minutes

Study Arms (2)

Tenaculum Group

ACTIVE COMPARATOR

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

Procedure: endometrial biopsyProcedure: Tenaculum Application

Valsalva Maneuver Group

ACTIVE COMPARATOR

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

Procedure: endometrial biopsyProcedure: Valsalva Maneuver

Interventions

endometrial biopsyPROCEDURE

Endometrial sampling performed using a pipelle cannula.

Tenaculum GroupValsalva Maneuver Group
Tenaculum ApplicationPROCEDURE

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

Tenaculum Group
Valsalva ManeuverPROCEDURE

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

Valsalva Maneuver Group

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cemil Tascioglu City Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

MetrorrhagiaPain

Interventions

Valsalva Maneuver

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaRespiratory Physiological Phenomena

Central Study Contacts

Neslihan Doctor

CONTACT

00905334215976neslihanoztopuz@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician, Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

December 16, 2025

First Posted

March 27, 2026

Study Start

January 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 27, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)