Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Control During First Trimester Abortion
- Conditions
- Abortion in First Trimester
- Interventions
- Device: Transcutaneous electrical nerve stimulation (TENS)Drug: Moderate IV Sedation
- Registration Number
- NCT03187002
- Lead Sponsor
- Stanford University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 109
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Transcutaneous electrical nerve stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS) Moderate IV Sedation Moderate IV Sedation Fentanyl, versed
- Primary Outcome Measures
Name Time Method Aspiration Pain Intraoperative, collected during procedure at the time of aspiration (up to 30 seconds) Pain with aspiration, assessed by visual analogue scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")
- Secondary Outcome Measures
Name Time Method Speculum Placement Pain Intraoperative, collected during procedure (up to 30 seconds) Pain with speculum placement, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")
Manual Cervical Dilation Pain Intraoperative, 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")
Tenaculum Placement Pain Intraoperative, collected during procedure (up to 30 seconds) Pain at time of tenaculum placement, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")
Paracervical Block Pain Intraoperative, collected during procedure (up to 30 seconds) Pain with paracervical block, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")
Speculum Removal Pain Intraoperative, collected during procedure (up to 30 seconds) Pain with speculum removal, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")
Total Procedure Time Intraoperative, collected during procedure (up to 20 minutes) Time from speculum placement to speculum removal, measured in minutes
Trial Locations
- Locations (1)
Planned Parenthood Mar Monte
🇺🇸San Jose, California, United States