Transcutaneous Electrical Nerve Stimulation During Outpatient Endometrial Biopsy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Active TENS Participants will be connected to a TENS 7000 that is turned on and working |
Device: TENS 7000
TENS device to be used in both the active and placebo groups
|
| Placebo Comparator: Placebo TENS Participants will be connected to a TENS 7000 however it will not be connected / will not be working |
Device: TENS 7000
TENS device to be used in both the active and placebo groups
|
Outcome Measures
Primary Outcome Measures
- Pain after Endometrial Biopsy, as measured by Visual Analogue Scale (VAS) [Immediately after endometrial biopsy]
Scores are measured on a 100 mm VAS. The VAS ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain
Secondary Outcome Measures
- Number of participants who find the intervention acceptable based on survey response [End of procedure]
A 0 to 100 mm scale similar to VAS to assess acceptability of TENS intervention
- Number of participants who find the intervention tolerable based on survey response [End of procedure]
A 0 to 100 mm scale similar to VAS to assess tolerability of TENS intervention
- Change in Pain, as measured by Visual Analogue Scale (VAS) across different time intervals [Speculum placement, tenaculum placement, 5 minutes after biopsy, and 15 minutes after biopsy]
Scores are measured on a 100 mm VAS. The VAS ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain
- Provider satisfaction with the procedure [End of procedure]
A 0 to 100 mm scale similar to VAS to assess provider satisfaction
Eligibility Criteria
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
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pacemaker or automatic implanted cardiac defibrillator
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inability to understand or declines to sign the informed consent form
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previous personal experience using a TENS unit
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pregnant women (will be excluded as part of standard of care for endometrial evaluation)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Duke University
Investigators
- Principal Investigator: Laura Havrilesky, MD, Duke University
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Lisón JF, Amer-Cuenca JJ, Piquer-Martí S, Benavent-Caballer V, Biviá-Roig G, Marín-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.
- 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.
- Pro00111100