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High-frequency, high-intensity transcutaneous electrical nerve-stimulation (TENS) is an inexpensive and non-invasive pain control approach. TENS, pulsating electrical currents that activate underlying nerves, does not have drug interactions or risk of overdose. Cochrane review of TENS for acute pain found inconclusive evidence. One previous abortion trial comparing TENS to IV sedation only looked at pain control in the recovery room. The investigators propose a randomized controlled trial comparing TENS to IV sedation (in conjunction with local anesthesia) among women presenting for first-trimester surgical abortion. Primary outcome will be perceived pain by Visual Analogue Scale (VAS) during aspiration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous electrical nerve stimulation (TENS) | Experimental | Transcutaneous electrical nerve stimulation (TENS) |
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| Moderate IV Sedation | Active Comparator | Fentanyl, versed |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous electrical nerve stimulation (TENS) | Device | Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders. |
| Measure | Description | Time Frame |
|---|---|---|
| Aspiration Pain | Pain with aspiration, assessed by visual analogue scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable") | Intraoperative, collected during procedure at the time of aspiration (up to 30 seconds) |
| Measure | Description | Time Frame |
|---|---|---|
| Speculum Placement Pain | Pain with speculum placement, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable") | Intraoperative, collected during procedure (up to 30 seconds) |
| Tenaculum Placement Pain |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Principal Investigator, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood Mar Monte | San Jose | California | 95126 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34352845 | Derived | 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. |
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All recruitment occurred at the Planned Parenthood site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Transcutaneous Electrical Nerve Stimulation (TENS) | Transcutaneous electrical nerve stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS): Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders. SHAM: Moderate IV Sedation: Sham IV to ensure blinding |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 29, 2019 |
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| Moderate IV Sedation | Drug | IV sedation with fentanyl and versed |
|
| SHAM: Transcutaneous electrical nerve stimulation (TENS) | Other | Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding |
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| SHAM: Moderate IV Sedation | Other | Sham IV to ensure blinding |
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Pain at time of tenaculum placement, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")
| Intraoperative, collected during procedure (up to 30 seconds) |
| Paracervical Block Pain | Pain with paracervical block, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable") | Intraoperative, collected during procedure (up to 30 seconds) |
| Manual Cervical Dilation Pain | Pain with manual cervical dilation, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable") | Intraoperative, collected during procedure (up to 30 seconds) |
| Speculum Removal Pain | Pain with speculum removal, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable") | Intraoperative, collected during procedure (up to 30 seconds) |
| Total Procedure Time | Time from speculum placement to speculum removal, measured in minutes | Intraoperative, collected during procedure (up to 20 minutes) |
| FG001 | Moderate IV Sedation | Fentanyl, versed Moderate IV Sedation: IV sedation with fentanyl and versed SHAM: Transcutaneous electrical nerve stimulation (TENS): Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Transcutaneous Electrical Nerve Stimulation (TENS) | Transcutaneous electrical nerve stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS): Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders. SHAM: Moderate IV Sedation: Sham IV to ensure blinding |
| BG001 | Moderate IV Sedation | Fentanyl, versed Moderate IV Sedation: IV sedation with fentanyl and versed SHAM: Transcutaneous electrical nerve stimulation (TENS): Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Gestational Age | Measured by ultrasound on day of enrollment and procedure | Median | Full Range | days |
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| 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 | Aspiration Pain | Pain with aspiration, assessed by visual analogue scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable") | 9 participants required rescue medication (IV sedation with fentanyl and versed) during the procedure in the TENS group and were excluded from per-protocol analysis. | Posted | Median | Full Range | units on a scale | Intraoperative, collected during procedure at the time of aspiration (up to 30 seconds) |
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| Secondary | Speculum Placement Pain | Pain with speculum placement, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable") | 9 participants required rescue medication (IV sedation with fentanyl and versed) during the procedure in the TENS group and were excluded from per-protocol analysis. | Posted | Median | Full Range | units on a scale | Intraoperative, collected during procedure (up to 30 seconds) |
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| Secondary | Tenaculum Placement Pain | Pain at time of tenaculum placement, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable") | 9 participants required rescue medication (IV sedation with fentanyl and versed) during the procedure in the TENS group and were excluded from per-protocol analysis. | Posted | Median | Full Range | units on a scale | Intraoperative, collected during procedure (up to 30 seconds) |
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| Secondary | Paracervical Block Pain | Pain with paracervical block, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable") | 9 participants required rescue medication (IV sedation with fentanyl and versed) during the procedure in the TENS group and were excluded from per-protocol analysis. | Posted | Median | Full Range | units on a scale | Intraoperative, collected during procedure (up to 30 seconds) |
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| Secondary | Manual Cervical Dilation Pain | Pain with manual cervical dilation, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable") | 9 participants required rescue medication (IV sedation with fentanyl and versed) during the procedure in the TENS group and were excluded from per-protocol analysis. | Posted | Median | Full Range | units on a scale | Intraoperative, collected during procedure (up to 30 seconds) |
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| Secondary | Speculum Removal Pain | Pain with speculum removal, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable") | 9 participants required rescue medication (IV sedation with fentanyl and versed) during the procedure in the TENS group and were excluded from per-protocol analysis. | Posted | Median | Full Range | units on a scale | Intraoperative, collected during procedure (up to 30 seconds) |
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| Secondary | Total Procedure Time | Time from speculum placement to speculum removal, measured in minutes | 9 participants required rescue medication (IV sedation with fentanyl and versed) during the procedure in the TENS group and were excluded from per-protocol analysis. | Posted | Median | Full Range | minutes | Intraoperative, collected during procedure (up to 20 minutes) |
|
Up to 4 hours
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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 | Transcutaneous Electrical Nerve Stimulation (TENS) | Transcutaneous electrical nerve stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS): Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders. SHAM: Moderate IV Sedation: Sham IV to ensure blinding | 0 | 55 | 0 | 55 | 0 | 55 |
| EG001 | Moderate IV Sedation | Fentanyl, versed Moderate IV Sedation: IV sedation with fentanyl and versed SHAM: Transcutaneous electrical nerve stimulation (TENS): Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding | 0 | 54 | 0 | 54 | 0 | 54 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Manager | Stanford University | 6507211567 | fpresearch@stanford.edu |
| Oct 1, 2020 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Fentanyl, versed
Moderate IV Sedation: IV sedation with fentanyl and versed
SHAM: Transcutaneous electrical nerve stimulation (TENS): Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding
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