The Effect of the Valsalva Maneuver in Endometrial Biopsy: A Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: endometrial biopsy, Tenaculum Application, Valsalva Maneuver.
- Who it may be relevant to
- Registry conditions: Pain in Endometrial Biopsy, Abnormal Uterine Bleeding. Basic parameters: 18 years — 55 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of the Valsalva Maneuver on Pain and Procedure Success in Endometrial Biopsy: A Randomized Controlled Trial
Overview
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
- 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. - Procedure Valsalva Maneuver
Patients perform the Valsalva maneuver during endometrial biopsy to reduce perceived pain.
Primary outcome measures
- Visual Analog Scale(VAS) scores [Time frame: Baseline, immediately before the procedure, intra-procedural, and 15 minutes post-procedure]
Secondary outcome measures (1)
- Procedure Success and Patient Satisfaction [Time frame: Up to 15 minutes]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
Turkey (Türkiye) · 1 center
- Cemil Tascioglu City Hospital — Istanbul
Identifiers
NCT: NCT07496905 · CemiltascıogluERHO-420