Pain in Endometrial Biopsy, Abnormal Uterine Bleeding
Conditions
Keywords
endometrial biopsy, valsalva maneuver, Pain
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.
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.
Interventions
PROCEDUREendometrial biopsy
Endometrial sampling performed using a pipelle cannula.
PROCEDURETenaculum Application
Application of a tenaculum to the cervix to stabilize it during endometrial biopsy.
PROCEDUREValsalva Maneuver
Patients perform the Valsalva maneuver during endometrial biopsy to reduce perceived pain.
Sponsors
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale(VAS) scores | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Success and Patient Satisfaction | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTNeslihan Doctor
Outcome results
None listed