Clinical trial NCT05472740: Transcutaneous Electrical Nerve Stimulation During Outpatient Endometrial Biopsy
Official title: Transcutaneous Electrical Nerve Stimulation for Analgesia During Outpatient Endometrial Biopsy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Diseases
Pain, Postoperative
Keywords: endometrial biopsy
transcutaneous electrical nerve stimulation
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 149
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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
* pregnant women (will be excluded as part of standard of care for endometrial evaluation)

Primary outcomes:
measure: Pain after Endometrial Biopsy, as measured by Visual Analogue Scale (VAS)
timeFrame: Immediately after endometrial biopsy
Secondary outcomes:
measure: Number of participants who find the intervention acceptable based on survey response
timeFrame: End of procedure
measure: Number of participants who find the intervention tolerable based on survey response
timeFrame: End of procedure
measure: Change in Pain, as measured by Visual Analogue Scale (VAS) across different time intervals
timeFrame: Speculum placement, tenaculum placement, 5 minutes after biopsy, and 15 minutes after biopsy
measure: Provider satisfaction with the procedure
timeFrame: End of procedure
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Laura Havrilesky, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lerma K, Goldthwaite LM, Blumenthal PD, Shaw KA. Transcutaneous Electrical Nerve Stimulation for Pain Management of Aspiration Abortion up to 83 Days of Gestation: A Randomized Controlled Trial. Obstet Gynecol. 2021 Sep 1;138(3):417-425. doi: 10.1097/AOG.0000000000004502.
citation: Yilmazer M, Kose S, Arioz DT, Koken G, Ozbulut O. Efficacy of transcutaneous electrical nerve stimulation for pain relief in women undergoing office endometrial biopsy. Arch Gynecol Obstet. 2012 Apr;285(4):1059-64. doi: 10.1007/s00404-011-2111-7. Epub 2011 Oct 19.
citation: Lison JF, Amer-Cuenca JJ, Piquer-Marti S, Benavent-Caballer V, Bivia-Roig G, Marin-Buck A. Transcutaneous Nerve Stimulation for Pain Relief During Office Hysteroscopy: A Randomized Controlled Trial. Obstet Gynecol. 2017 Feb;129(2):363-370. doi: 10.1097/AOG.0000000000001842.