Transcutaneous Electrical Nerve Stimulation During Outpatient Endometrial Biopsy

Duke University

Status: Completed

Conditions: Endometrial Diseases; Pain, Postoperative

Treatments: Device: TENS 7000

Study type: Interventional

Funder types: Other

Identifiers

NCT05472740

Pro00111100

Details and patient eligibility

About

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.

Enrollment: 149 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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149 participants in 2 patient groups, including a placebo group

Active TENS

Experimental group

Description:

Participants will be connected to a TENS 7000 that is turned on and working

Treatment:

Device: TENS 7000

Placebo TENS

Placebo Comparator group

Description:

Participants will be connected to a TENS 7000 however it will not be connected / will not be working

Treatment:

Device: TENS 7000