Pain in Endometrial BiopsyNCT07496905
The Effect of the Valsalva Maneuver in Endometrial Biopsy: A Randomized Controlled Trial
A study testing endometrial biopsy, Tenaculum Application and Valsalva Maneuver in people with Pain in Endometrial Biopsy and Abnormal Uterine Bleeding, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain in Endometrial Biopsy, Abnormal Uterine Bleeding
- What is being tested?
- endometrial biopsy, Tenaculum Application and Valsalva Maneuver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 21 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- -Endometrial sampling indication in reproductive age group of patients over 18 years of age, who can communicate in Turkish.
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Valsalva Maneuver on Pain and Procedure Success in Endometrial Biopsy: A Randomized Controlled 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.
Read the 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.
- Being tested
- endometrial biopsy, Tenaculum Application, Valsalva Maneuver
- Keywords
- endometrial biopsy, valsalva maneuver, Pain
- Medical subject headings
- Metrorrhagia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endometrial biopsyProcedure or surgery
Endometrial sampling performed using a pipelle cannula.
Tenaculum ApplicationProcedure or surgery
Application of a tenaculum to the cervix to stabilize it during endometrial biopsy.
Valsalva ManeuverProcedure or surgery
Patients perform the Valsalva maneuver during endometrial biopsy to reduce perceived pain.
| Study group | Role | What they receive |
|---|---|---|
| Tenaculum Group | Active comparator | Patients undergo endometrial biopsy using a pipelle cannula, either with the application of a tenaculum or while performing the Valsalva maneuver. Receives: Procedure: endometrial biopsy; Procedure: Tenaculum Application |
| Valsalva Maneuver Group | Active comparator | Patients perform the Valsalva maneuver during endometrial biopsy using a pipelle cannula. Receives: Procedure: endometrial biopsy; Procedure: Valsalva Maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Jan 2025
- Primary completion20 Jun 2026
- Study completion21 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain in Endometrial BiopsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neslihan Bademler, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496905
- Sponsor's protocol ID
- CemiltascıogluERHO-420
- Status last verified
- Aug 2026
- First submitted
- 16 Dec 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Valsalva Maneuver on Pain and Procedure Success in Endometrial Biopsy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07496905
- Acronym / sponsor ID
- CemiltascıogluERHO-420
- Keywords
- endometrial biopsy, valsalva maneuver, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 20 Jun 2026 (actual)
- Study completion
- 21 Jun 2026 (actual)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tenaculum Group | Active comparator | Procedure: endometrial biopsy, Procedure: Tenaculum ApplicationPatients undergo endometrial biopsy using a pipelle cannula, either with the application of a tenaculum or while performing the Valsalva maneuver. |
| Valsalva Maneuver Group | Active comparator | Procedure: endometrial biopsy, Procedure: Valsalva ManeuverPatients perform the Valsalva maneuver during endometrial biopsy using a pipelle cannula. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -Endometrial sampling indication in reproductive age group of patients over 18 years of age, who can communicate in Turkish.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endometrial biopsyEndometrial sampling performed using a pipelle cannula. | Procedure or surgery | Tenaculum Group, Valsalva Maneuver Group |
| Tenaculum ApplicationApplication of a tenaculum to the cervix to stabilize it during endometrial biopsy. | Procedure or surgery | Tenaculum Group |
| Valsalva ManeuverPatients perform the Valsalva maneuver during endometrial biopsy to reduce perceived pain. | Procedure or surgery | Valsalva Maneuver Group |
Primary outcome
Visual Analog Scale(VAS) scores
Time frame: 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.
1 secondary outcome
Procedure Success and Patient Satisfaction
Time frame: Up to 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endometrial biopsy, Tenaculum Application and Valsalva Maneuver in people with Pain in Endometrial Biopsy and Abnormal Uterine Bleeding, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale(VAS) scores (time frame: Baseline, immediately before the procedure, intra-procedural, and 15 minutes post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.