Transcutaneous Electrical Nerve Stimulation During Outpatient Endometrial Biopsy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-13

Study Completion Date

2023-12-26

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.

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Detailed Description

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Conditions

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Endometrial Diseases Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

The participant and the provider completing the endometrial biopsy will be blinded to what group (intervention or placebo) that the subject is in. The clinical research coordinator assisting with the study and placement of the TENS will not be blinded.

Study Groups

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Active TENS

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

Group Type EXPERIMENTAL

TENS 7000

Intervention Type DEVICE

TENS device to be used in both the active and placebo groups

Placebo TENS

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

Group Type PLACEBO_COMPARATOR

TENS 7000

Intervention Type DEVICE

TENS device to be used in both the active and placebo groups

Interventions

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TENS 7000

TENS device to be used in both the active and placebo groups

Intervention Type DEVICE

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
* concurrent procedure (ex. IUD placement at time of biopsy)
* pregnant women (will be excluded as part of standard of care for endometrial evaluation)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes