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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
149
TENS device to be used in both the active and placebo groups
Duke University Medical Center
Durham, North Carolina, United States
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
Time frame: Immediately after endometrial biopsy
Measure of the Intervention Acceptability Based on Survey Response
A 0 to 100 mm scale similar to VAS (visual analog scale) to assess acceptability of TENS (Transcutaneous Electrical Nerve Stimulation) intervention. 0 - completely acceptable to 100 - not at all acceptable
Time frame: End of procedure
Tolerability of Procedure, as Measured by Visual Analogue Scale (VAS)
A 0 to 100 mm scale similar to VAS to assess tolerability of TENS (Transcutaneous Electrical Nerve Stimulation) intervention.
Time frame: End of procedure
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
Time frame: 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 (visual analog scale) to assess provider satisfaction
Time frame: End of procedure
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