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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorProf. Dr. Cemil Tascıoglu Education and Research Hospital Organization

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Patients under 18 years of age - postmenopausal

Pregnancy

Patients with known stenotic cervical os

Patients with a history of acute cervicitis;

Trial design

Design model

Parallel

Treatments tested in this trial

  • endometrial biopsy

    Procedure/Surgery

    Endometrial sampling performed using a pipelle cannula.

  • Tenaculum Application

    Procedure/Surgery

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

  • Valsalva Maneuver

    Procedure/Surgery

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

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Tenaculum GroupActive comparator 2 interventions
Group B: Valsalva Maneuver GroupActive comparator 2 interventions

Trial outcomes

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.

Time frame
Baseline, immediately before the procedure, intra-procedural, and 15 minutes post-procedure

Secondary outcomes

1

Procedure Success and Patient Satisfaction

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.

Time frame
Up to 15 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.