- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05320432
Transcutaneous Electrical Nerve Stimulation for Pain Control During First-trimester Abortion (TENS 2 0)
Transcutaneous Electrical Nerve Stimulation for Pain Control During First Trimester Abortion: a Blinded Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Palo Alto, California, United States, 94305
- Stanford University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 years old or older
- English- or Spanish-fluency
- <12 weeks gestation
- Presenting for aspiration abortion
Exclusion Criteria:
- Planned use of oral or IV sedation
- Contraindications to office-based procedure as determined by attending physician
- Fetal demise
- Requiring pre-procedure use of misoprostol
- Contraindication to TENS units use (pacemaker or epilepsy)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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).
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A low-level electrical current through the skin activates the descending inhibitory systems in the central nervous system.
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Sham Comparator: Sham
For the participants randomized to sham, the same placement of electrodes will occur, but the unit will not be delivering electrical stimulation.
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No current applied through pads.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain during cervical dilation
Time Frame: Intra-operative, collected during procedure (up to 30 seconds)
|
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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain during procedure
Time Frame: Intra-operative, collected during procedure (up to 30 seconds)
|
Pain throughout procedure, 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)
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Time spent in recovery area
Time Frame: Post-operative, collected following procedure (up to 20 minutes)
|
Post-operative, collected following procedure (up to 20 minutes)
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 62478
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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