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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
endometrial biopsy
Procedure/SurgeryEndometrial sampling performed using a pipelle cannula.
Tenaculum Application
Procedure/SurgeryApplication of a tenaculum to the cervix to stabilize it during endometrial biopsy.
Valsalva Maneuver
Procedure/SurgeryPatients perform the Valsalva maneuver during endometrial biopsy to reduce perceived pain.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Sponsors and contacts
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