Transcutaneous Electrical Nerve Stimulation During Outpatient Endometrial Biopsy

Study Overview
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Brief Summary
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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.

Official Title
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Transcutaneous Electrical Nerve Stimulation for Analgesia During Outpatient Endometrial Biopsy: a Randomized Controlled Trial

Conditions
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Endometrial Diseases, Pain, Postoperative

Intervention / Treatment
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* Device: TENS 7000


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active TENS<br>Participants will be connected to a TENS 7000 that is turned on and working | Device: TENS 7000<br>* TENS device to be used in both the active and placebo groups<br>|
| Placebo Comparator: Placebo TENS<br>Participants will be connected to a TENS 7000 however it will not be connected / will not be working | Device: TENS 7000<br>* TENS device to be used in both the active and placebo groups<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain after Endometrial Biopsy, as measured by Visual Analogue Scale (VAS) | 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 | Immediately after endometrial biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who find the intervention acceptable based on survey response | A 0 to 100 mm scale similar to VAS to assess acceptability of TENS intervention | End of procedure | 
| Number of participants who find the intervention tolerable based on survey response | A 0 to 100 mm scale similar to VAS to assess tolerability of TENS intervention | End of procedure | 
| Change in Pain, as measured by Visual Analogue Scale (VAS) across different time intervals | 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 | Speculum placement, tenaculum placement, 5 minutes after biopsy, and 15 minutes after biopsy | 
| Provider satisfaction with the procedure | A 0 to 100 mm scale similar to VAS to assess provider satisfaction | End of procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometrial biopsy, transcutaneous electrical nerve stimulation