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Completed

NCT Number: NCT05472740

Transcutaneous Electrical Nerve Stimulation During Outpatient Endometrial Biopsy

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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Key information

Conditions

Endometrial Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Urogenital Diseases Uterine Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

TENS 7000

Device

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

Primary outcomes

  1. Pain After Endometrial Biopsy, as Measured by Visual Analogue Scale (VAS)

    Time frame: 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 outcomes

  1. Measure of the Intervention Acceptability Based on Survey Response

    Time frame: End of procedure

    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

  2. Tolerability of Procedure, as Measured by Visual Analogue Scale (VAS)

    Time frame: End of procedure

    A 0 to 100 mm scale similar to VAS to assess tolerability of TENS (Transcutaneous Electrical Nerve Stimulation) intervention.

  3. Pain, as Measured by Visual Analogue Scale (VAS) Across Different Time Intervals

    Time frame: 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

  4. Provider Satisfaction With the Procedure

    Time frame: End of procedure

    A 0 to 100 mm scale similar to VAS (visual analog scale) to assess provider satisfaction

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 25, 2022
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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