N/A
Completed N=149
Transcutaneous Electrical Nerve Stimulation During Outpatient Endometrial Biopsy
Endometrial Diseases · Pain, Postoperative
Source: ClinicalTrials.gov NCT05472740 ↗
Enrolled (actual)
149
Serious AEs
0.7%
Results posted
Aug 2025
Primary outcomePrimary: Pain After Endometrial Biopsy, as Measured by Visual Analogue Scale (VAS) — 50; 60 mm — p=0.039
Summary
The purpose of this study is to see whether transcutaneous electrical nerve stimulation (or TENS) reduces pain during an endometrial biopsy. A TENS unit is an over-the-counter, FDA approved device that sends low-level electrical impulses through the skin to reduce the amount of discomfort experienced during procedures. A TENS unit is very low-risk and used in a lot of ways, including for chronic pain, after surgery, and during labor. Since there is no standard way of managing discomfort during an endometrial biopsy, the investigators think that TENS might be helpful.
Participating in the study may require some additional time in clinic to answer research-related questions. Subjects will be asked to answer demographic questions (which will be combined anonymously) before and after the procedure, as well as rate subject's pain at different time points during the procedure.
The biggest benefit in participating is that subject's discomfort might be lower during and after the procedure. Subjects may not benefit from participating in this study. There is a small risk of a skin reaction from wearing the TENS pads.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain After Endometrial Biopsy, as Measured by Visual Analogue Scale (VAS) |
50; 60 | 0.039 sig |
| SECONDARY Measure of the Intervention Acceptability Based on Survey Response |
0; 0 | — |
| SECONDARY Tolerability of Procedure, as Measured by Visual Analogue Scale (VAS) |
17.5; 30 | — |
| SECONDARY Pain, as Measured by Visual Analogue Scale (VAS) Across Different Time Intervals |
20; 10; 50; 55; 10; 20 | — |
| SECONDARY Provider Satisfaction With the Procedure |
— | — |
Eligibility Criteria
Inclusion Criteria
- at least 18 years old
- undergoing an outpatient endometrial biopsy
- Duke gynecological oncology clinics and general gynecology clinic
Exclusion Criteria
- age younger than 18 years
- unable to follow study instructions and/or independently adjust TENS settings
- cutaneous damage at the TENS application site
- pacemaker or automatic implanted cardiac defibrillator
- inability to understand or declines to sign the informed consent form
- previous personal experience using a TENS unit
- concurrent procedure (ex. IUD placement at time of biopsy)
- pregnant women (will be excluded as part of standard of care for endometrial evaluation)
Data sourced from ClinicalTrials.gov (NCT05472740). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.