Valsalva maneuver to reduce pain during pipelle endometrial biopsy
The Effect of the Valsalva Maneuver on Pain and Procedure Success in Endometrial Biopsy: A Randomized Controlled Trial
This study will test whether doing a Valsalva maneuver (bearing down) during a pipelle endometrial biopsy can reduce pain and anxiety for adult women having endometrial sampling.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization Academic / other |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT07496905 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial compares pipelle endometrial sampling performed with the Valsalva maneuver versus the conventional method using a tenaculum. Adult women who meet inclusion criteria are randomly assigned to one of the two techniques, and clinicians record pain scores, procedure success, patient anxiety, and overall satisfaction. Primary outcomes are patient-reported pain during the procedure and technical success of the sampling; secondary outcomes include anxiety and satisfaction measures. The trial is conducted at Cemil Tascioglu City Hospital in Istanbul and excludes pregnant, postmenopausal, and other patients with predefined cervical or uterine conditions.
Who should consider this trial
Good fit: Ideal candidates are adult, reproductive-age women who need pipelle endometrial sampling for abnormal uterine bleeding and can follow instructions in Turkish.
Not a fit: Patients who are pregnant, postmenopausal, have a stenotic cervical os, acute cervicitis, severe anxiety, or uterine anatomy/pathology that affects sampling are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this simple maneuver could lower procedure-related pain and anxiety and reduce the need for using a tenaculum during many pipelle samplings.
How similar studies have performed: The Valsalva maneuver has physiological rationale and has been used in other minor procedures, but randomized data directly comparing it to tenaculum use in pipelle biopsies are limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Istanbul
- Cemil Tascioglu City Hospital — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Neslihan Doctor
- Email: neslihanoztopuz@gmail.com
- Phone: 00905334215976
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.