Transcutaneous Electrical Nerve Stimulation for Analgesia During Outpatient Endometrial Biopsy: a Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Endometrial Diseases
- Sponsor
- Duke University
- Enrollment
- 149
- Locations
- 1
- Primary Endpoint
- Pain After Endometrial Biopsy, as Measured by Visual Analogue Scale (VAS)
- Status
- Completed
- Last Updated
- 8 months ago
Overview
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.
Investigators
Eligibility 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
- •concurrent procedure (ex. IUD placement at time of biopsy)
- •pregnant women (will be excluded as part of standard of care for endometrial evaluation)
Outcomes
Primary Outcomes
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
- Measure of the Intervention Acceptability Based on Survey Response(End of procedure)
- Tolerability of Procedure, as Measured by Visual Analogue Scale (VAS)(End of procedure)
- 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)
- Provider Satisfaction With the Procedure(End of procedure)