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First-trimester abortion aspiration procedures are painful and sedation is typically provided. It is unsafe to drive after sedation due to the prolonged motor delay from some anesthetic agents. Without a known escort, most clinics do not allow patients to use public transportation, taxis, or rideshare services. Arranging a ride may be harder for those seeking abortion care than other surgical procedures given privacy concerns and the need to travel far distances. Additionally, some people have medical reasons that makes sedation in an outpatient abortion clinic unsafe. As abortion restrictions increase and more people need to travel far distances to access care, it is important to investigate non-pharmacologic pain control options.
Transcutaneous electrical nerve stimulation (TENS) delivers a low-level electrical current through the skin. By activating the descending inhibitory systems in the central nervous system, these pulses of electrical current reduce sensitivity to pain. TENS has been shown to be effective in decreasing pain with menstrual cramps and during medication abortion, and it was found to be non-inferior to IV sedation for first-trimester procedural abortion. However, it remains unclear if TENS is better than ibuprofen and local anesthesia via paracervical block alone.
The overarching goal of this research is to identify an inexpensive, non-pharmacologic, alternative pain control strategy for those with a medical or social contraindication to IV sedation. The specific aim of this project is to evaluate the efficacy of TENS to prevent pain during first-trimester procedural abortion. To achieve this objective, a blinded, randomized superiority trial comparing the use of TENS to sham for management of pain during first-trimester aspiration abortion is proposed. This research is significant because the validation of a non-pharmacologic pain management technique would decrease barriers to accessing abortion care.
Abortion is common: one in four individuals will seek this care during their reproductive lifetime. Most abortions occur in the first trimester and nearly all - greater than 95% - occur in the outpatient clinic setting. Uterine aspiration is painful; most patients desire additional analgesia beyond local anesthesia. However, not every patient is a candidate for office sedation since multiple medical conditions are a contraindication and patients must have a ride home. The prolonged motor delay from some anesthetic agents makes driving after sedation unsafe. Without a known escort to monitor for surgical and anesthetic complications as recommended by the American Society of Anesthesia, most clinics do not allow patients to use public transportation, taxis, or rideshare services. Arranging a ride may be harder for those seeking abortion care than other surgical procedures given privacy concerns and the need to travel far distances. As abortion restrictions increase and more people need to travel far distances to access care, it is important to investigate non-pharmacologic pain control options. Transcutaneous electrical nerve stimulation (TENS) delivers an electrical current through the skin to activate the descending inhibitory systems in the central nervous system, effectively reducing sensitivity to pain. A previous trial comparing TENS to IV sedation found similar postoperative pain scores with a significantly shorter recovery time in the TENS group; however, this study did not evaluate or report intraoperative pain scores. It was found in a randomized controlled trial comparing TENS to IV sedation (in conjunction with local anesthesia) for first-trimester surgical abortion and that TENS had non-inferior pain scores to IV sedation and was considered an acceptable modality for pain control among participants. Through this proposed double blinded randomized controlled trial, it is hoped to demonstrate that TENS is a superior, non-invasive alternative pain control option for people undergoing surgical abortion in the first trimester who otherwise are not eligible for or decline IV sedation. Ultimately, the hope is to identify an inexpensive, alternative, non-pharmacologic pain control strategy for those with a medical or social contraindication to IV sedation in an effort to decrease barriers to accessing abortion care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous electrical nerve stimulation (TENS) | Experimental | Prior to the procedure, the patient will have two sets of two self-adhesive electrodes placed parallel to the spinal cord at the T10-L1 and S2-S4 levels for TENS administration. For participants randomized to the experimental group, the non-blinded study coordinator will turn on the TENS unit 5 minutes prior to the procedure and monitor stimulating frequency level (80-100 Hz and pulse duration of 400 microseconds; intensity or frequency will be monitored to be administered to a non-painful level). |
|
| Sham | Sham Comparator | For the participants randomized to sham, the same placement of electrodes will occur, but the unit will not be delivering electrical stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous electrical nerve stimulation (TENS) | Device | A low-level electrical current through the skin activates the descending inhibitory systems in the central nervous system. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain During Cervical Dilation | Pain with manual cervical dilation, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable") | Intra-operative, collected during procedure (up to 30 seconds) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain During Procedure | Pain during aspiration assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable") | Intra-operative, collected during procedure (up to 30 seconds) |
| Overall Experience |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Transcutaneous Electrical Nerve Stimulation (TENS) | Prior to the procedure, the patient will have two sets of two self-adhesive electrodes placed parallel to the spinal cord at the T10-L1 and S2-S4 levels for TENS administration. For participants randomized to the experimental group, the non-blinded study coordinator will turn on the TENS unit 5 minutes prior to the procedure and monitor stimulating frequency level (80-100 Hz and pulse duration of 400 microseconds; intensity or frequency will be monitored to be administered to a non-painful level). Transcutaneous electrical nerve stimulation (TENS): A low-level electrical current through the skin activates the descending inhibitory systems in the central nervous system. |
| FG001 | Sham | For the participants randomized to sham, the same placement of electrodes will occur, but the unit will not be delivering electrical stimulation. Sham: No current applied through pads. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Transcutaneous Electrical Nerve Stimulation (TENS) | Prior to the procedure, the patient will have two sets of two self-adhesive electrodes placed parallel to the spinal cord at the T10-L1 and S2-S4 levels for TENS administration. For participants randomized to the experimental group, the non-blinded study coordinator will turn on the TENS unit 5 minutes prior to the procedure and monitor stimulating frequency level (80-100 Hz and pulse duration of 400 microseconds; intensity or frequency will be monitored to be administered to a non-painful level). Transcutaneous electrical nerve stimulation (TENS): A low-level electrical current through the skin activates the descending inhibitory systems in the central nervous system. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 During Cervical Dilation | Pain with manual cervical dilation, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable") | Two excluded from sham as did not complete procedure. | Posted | Median | Full Range | millimeters on VAS | Intra-operative, collected during procedure (up to 30 seconds) |
|
2 weeks post-procedure
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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) | Prior to the procedure, the patient will have two sets of two self-adhesive electrodes placed parallel to the spinal cord at the T10-L1 and S2-S4 levels for TENS administration. For participants randomized to the experimental group, the non-blinded study coordinator will turn on the TENS unit 5 minutes prior to the procedure and monitor stimulating frequency level (80-100 Hz and pulse duration of 400 microseconds; intensity or frequency will be monitored to be administered to a non-painful level). Transcutaneous electrical nerve stimulation (TENS): A low-level electrical current through the skin activates the descending inhibitory systems in the central nervous system. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Stanford University | 650-497-5175 | gynresearch@stanford.edu |
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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 | Jul 1, 2022 | Jan 28, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 |
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| Sham | Device | No current applied through pads. |
|
Patient experience assessed by visual analog scale (VAS, 0-100mm; 0 being "worst experience possible" and 100 being "best experience possible")
| Post-operative, collected following procedure (up to 20 minutes) |
| Procedure Time | up to 20 minutes |
| Provider Perceived Ease of Procedure | Provider experience assessed by visual analog scale (VAS, 0-100mm; 0 being "easiest to use" and 100 being "most difficult to use") | Post-operative, collected after procedure (up to 30 seconds) |
| Time Spent in Recovery | up to 1 hour |
| Number of Participants Who Correctly Identified Whether They Received TENS or Sham | This outcome is to measure the participant's perceived group allocation. | Post-operative, collected after procedure (up to 30 seconds) |
| BG001 | Sham | For the participants randomized to sham, the same placement of electrodes will occur, but the unit will not be delivering electrical stimulation. Sham: No current applied through pads. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Nulliparous | Count of Participants | Participants |
|
| OG001 | Sham | For the participants randomized to sham, the same placement of electrodes will occur, but the unit will not be delivering electrical stimulation. Sham: No current applied through pads. |
|
|
| Secondary | Pain During Procedure | Pain during aspiration assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable") | Two participants excluded from sham - did not complete procedure | Posted | Median | Full Range | millimeters on VAS | Intra-operative, collected during procedure (up to 30 seconds) |
|
|
|
| Secondary | Overall Experience | Patient experience assessed by visual analog scale (VAS, 0-100mm; 0 being "worst experience possible" and 100 being "best experience possible") | Two excluded from sham - did not complete procedure | Posted | Median | Full Range | millimeters on VAS | Post-operative, collected following procedure (up to 20 minutes) |
|
|
|
| Secondary | Procedure Time | Two excluded from sham - did not complete procedure | Posted | Mean | Standard Deviation | minutes | up to 20 minutes |
|
|
|
| Secondary | Provider Perceived Ease of Procedure | Provider experience assessed by visual analog scale (VAS, 0-100mm; 0 being "easiest to use" and 100 being "most difficult to use") | Two excluded from sham - did not complete procedure | Posted | Median | Full Range | score on a scale | Post-operative, collected after procedure (up to 30 seconds) |
|
|
|
| Secondary | Time Spent in Recovery | Two excluded from sham - did not complete procedure | Posted | Mean | Standard Deviation | minutes | up to 1 hour |
|
|
|
| Secondary | Number of Participants Who Correctly Identified Whether They Received TENS or Sham | This outcome is to measure the participant's perceived group allocation. | Two participants excluded from sham - did not complete procedure | Posted | Count of Participants | Participants | Post-operative, collected after procedure (up to 30 seconds) |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Sham | For the participants randomized to sham, the same placement of electrodes will occur, but the unit will not be delivering electrical stimulation. Sham: No current applied through pads. | 0 | 35 | 0 | 35 | 0 | 35 |
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| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |