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Transcutaneous Electrical Nerve Stimulation During Outpatient Endometrial Biopsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05472740
Recruitment Status : Recruiting
First Posted : July 25, 2022
Last Update Posted : December 21, 2022
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Endometrial Diseases Pain, Postoperative Device: TENS 7000 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Transcutaneous Electrical Nerve Stimulation for Analgesia During Outpatient Endometrial Biopsy: a Randomized Controlled Trial
Actual Study Start Date : December 13, 2022
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Active TENS
Participants will be connected to a TENS 7000 that is turned on and working
 Device: TENS 7000
TENS device to be used in both the active and placebo groups
Placebo Comparator: Placebo TENS
Participants will be connected to a TENS 7000 however it will not be connected / will not be working
 Device: TENS 7000
TENS device to be used in both the active and placebo groups


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Number of participants who find the intervention acceptable based on survey response [ Time Frame: End of procedure ]
    A 0 to 100 mm scale similar to VAS to assess acceptability of TENS intervention

  2. Number of participants who find the intervention tolerable based on survey response [ Time Frame: End of procedure ]
    A 0 to 100 mm scale similar to VAS to assess tolerability of TENS intervention

  3. Change in 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 to assess provider satisfaction


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05472740


Contacts
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Contact: Amelia Scott 919-684-9065 amelia.lorenzo@duke.edu

Locations
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United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Amelia Scott    919-684-9065    amelia.lorenzo@duke.edu   
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Laura Havrilesky, MD Duke University
More Information
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Publications:

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT05472740    
Other Study ID Numbers: Pro00111100
First Posted: July 25, 2022    Key Record Dates
Last Update Posted: December 21, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Duke University:
endometrial biopsy
transcutaneous electrical nerve stimulation
Additional relevant MeSH terms:
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Uterine Diseases
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
 Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases