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NCT05320432 · ClinicalTrials.gov registry record · NA
Transcutaneous Electrical Nerve Stimulation for Pain Control During First-trimester Abortion
A NA study, sponsored by Stanford University.
- Completed
- Registry status
- NA
- Development phase
- 70
- Enrollment target
NCT05320432: Completed NA study, sponsored by Stanford University.
NCT05320432 is a NA study that has completed, run by Stanford University. The registered enrollment target is 70 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05320432, a NA study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- NA
- Development phase
- 70 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Pain with manual cervical dilation, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")
Interventions
- DEVICE Sham
- DEVICE Transcutaneous electrical nerve stimulation (TENS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2023-01-20 |
| Est. Completion | 2024-03-21 |
| Phase | NA |
What the finished NCT05320432 record still lists
NCT05320432 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Sham is the first listed.
NCT05320432 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05320432 about?
NCT05320432 is a clinical study titled "Transcutaneous Electrical Nerve Stimulation for Pain Control During First-trimester Abortion". 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 ridesha...
What is the current status of trial NCT05320432?
This trial is currently completed. It is a NA study. The enrollment target is 70 participants. The study started on 2023-01-20. Estimated completion is 2024-03-21.
What interventions are being tested in trial NCT05320432?
The interventions under investigation include: Sham (DEVICE), Transcutaneous electrical nerve stimulation (TENS) (DEVICE).
Who is sponsoring clinical trial NCT05320432?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05320432's enrollment target sits among peer trials
70 1103rd of 2000 higher than 868 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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