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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active TENS | Experimental | Participants will be connected to a TENS 7000 that is turned on and working |
|
| Placebo TENS | Placebo Comparator | Participants will be connected to a TENS 7000 however it will not be connected / will not be working |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TENS 7000 | Device | TENS device to be used in both the active and placebo groups |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain After Endometrial Biopsy, as Measured by Visual Analogue Scale (VAS) | 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 | Immediately after endometrial biopsy |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of the Intervention Acceptability Based on Survey Response | 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 | End of procedure |
| Tolerability of Procedure, as Measured by Visual Analogue Scale (VAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Havrilesky, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34352845 | Background | Lerma K, Goldthwaite LM, Blumenthal PD, Shaw KA. Transcutaneous Electrical Nerve Stimulation for Pain Management of Aspiration Abortion up to 83 Days of Gestation: A Randomized Controlled Trial. Obstet Gynecol. 2021 Sep 1;138(3):417-425. doi: 10.1097/AOG.0000000000004502. | |
| 22009510 | Background | Yilmazer M, Kose S, Arioz DT, Koken G, Ozbulut O. Efficacy of transcutaneous electrical nerve stimulation for pain relief in women undergoing office endometrial biopsy. Arch Gynecol Obstet. 2012 Apr;285(4):1059-64. doi: 10.1007/s00404-011-2111-7. Epub 2011 Oct 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active TENS | Participants will be connected to a TENS 7000 that is turned on and working. TENS 7000: TENS device to be used in both the active and placebo groups |
| FG001 | Placebo TENS | Participants will be connected to a TENS 7000 however it will not be connected / will not be working. TENS 7000: TENS device to be used in both the active and placebo groups |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active TENS | Participants will be connected to a TENS 7000 that is turned on and working TENS 7000: TENS device to be used in both the active and placebo groups |
| BG001 | Placebo TENS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain After Endometrial Biopsy, as Measured by Visual Analogue Scale (VAS) | 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 | Posted | Median | Inter-Quartile Range | mm | Immediately after endometrial biopsy |
|
Adverse event data were collected a week after the biopsy.
The study team looked for cases of post-procedural syncope, heavy bleeding, or reaction to TENS unit for a week following the biopsy. Any participant who experienced these was offered study withdrawal. Any need for hospitalization or death that was probably study related was immediately reported to the IRB.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active TENS | Participants will be connected to a TENS 7000 that is turned on and working TENS 7000: TENS device to be used in both the active and placebo groups |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Esophageal dysphagia | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Possible electrode burn | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amelia Scott, Research Program Leader | Duke University | (919) 613-4584 | amelia.lorenzo@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 23, 2023 | Oct 22, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 23, 2023 | Oct 22, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 2, 2023 | Jun 21, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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.
A 0 to 100 mm scale similar to VAS to assess tolerability of TENS (Transcutaneous Electrical Nerve Stimulation) intervention. |
| End of procedure |
| Pain, as Measured by Visual Analogue Scale (VAS) Across Different Time Intervals | 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 | Speculum placement, tenaculum placement, 5 minutes after biopsy, and 15 minutes after biopsy |
| Provider Satisfaction With the Procedure | A 0 to 100 mm scale similar to VAS (visual analog scale) to assess provider satisfaction | End of procedure |
| 28079781 | Background | Lison JF, Amer-Cuenca JJ, Piquer-Marti S, Benavent-Caballer V, Bivia-Roig G, Marin-Buck A. Transcutaneous Nerve Stimulation for Pain Relief During Office Hysteroscopy: A Randomized Controlled Trial. Obstet Gynecol. 2017 Feb;129(2):363-370. doi: 10.1097/AOG.0000000000001842. |
| 39575620 | Derived | Wu J, Lim S, Scott A, Hayes T, Unnithan S, Erkanli A, Havrilesky LJ, Swartz JJ. Transcutaneous Electric Nerve Stimulation for Analgesia During Outpatient Endometrial Biopsy: A Randomized Controlled Trial. Obstet Gynecol. 2025 Jan 1;145(1):e14-e23. doi: 10.1097/AOG.0000000000005727. Epub 2024 Nov 21. |
Participants will be connected to a TENS 7000 however it will not be connected / will not be working
TENS 7000: TENS device to be used in both the active and placebo groups
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| Secondary | Measure of the Intervention Acceptability Based on Survey Response | 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 | Posted | Median | Inter-Quartile Range | mm | End of procedure |
|
|
|
| Secondary | Tolerability of Procedure, as Measured by Visual Analogue Scale (VAS) | A 0 to 100 mm scale similar to VAS to assess tolerability of TENS (Transcutaneous Electrical Nerve Stimulation) intervention. | Posted | Median | Inter-Quartile Range | mm | End of procedure |
|
|
|
| Secondary | Pain, as Measured by Visual Analogue Scale (VAS) Across Different Time Intervals | 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 | Posted | Median | Inter-Quartile Range | mm | Speculum placement, tenaculum placement, 5 minutes after biopsy, and 15 minutes after biopsy |
|
|
|
| Secondary | Provider Satisfaction With the Procedure | A 0 to 100 mm scale similar to VAS (visual analog scale) to assess provider satisfaction | Data not collected due to unavailability of providers post-procedure. | Posted | End of procedure |
|
|
| 0 |
| 75 |
| 0 |
| 75 |
| 0 |
| 75 |
| EG001 | Placebo TENS | Participants will be connected to a TENS 7000 however it will not be connected / will not be working TENS 7000: TENS device to be used in both the active and placebo groups | 0 | 74 | 1 | 74 | 1 | 74 |
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| D000091662 | Genital Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| 5 min post biopsy |
|
| 15 min post biopsy |
|