Transcutaneous Electrical Nerve Stimulation During Outpatient Endometrial Biopsy

Not Applicable

Completed

• Conditions: Pain, Postoperative; Endometrial Diseases
• Interventions: Device: TENS 7000

• Registration Number: NCT05472740
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-22
• Study First Submitted QC: 2022-07-22
• Study First Posted: 2022-07-25
• Study Start: 2022-12-13
• Primary Completion: 2023-12-26
• Study Completion: 2023-12-26
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-08
• Last Update Posted: 2024-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 149

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active TENS	TENS 7000	Participants will be connected to a TENS 7000 that is turned on and working
Placebo TENS	TENS 7000	Participants will be connected to a TENS 7000 however it will not be connected / will not be working

Primary Outcome Measures

Name	Time	Method
Pain after Endometrial Biopsy, as measured by Visual Analogue Scale (VAS)	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

Name	Time	Method
Provider satisfaction with the procedure	End of procedure	A 0 to 100 mm scale similar to VAS to assess provider satisfaction
Number of participants who find the intervention acceptable based on survey response	End of procedure	A 0 to 100 mm scale similar to VAS to assess acceptability of TENS intervention
Number of participants who find the intervention tolerable based on survey response	End of procedure	A 0 to 100 mm scale similar to VAS to assess tolerability of TENS intervention
Change in Pain, as measured by Visual Analogue Scale (VAS) across different time intervals	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

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States