Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Control During First Trimester Abortion: A Blinded Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 109
- Locations
- 1
- Primary Endpoint
- Aspiration Pain
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Transcutaneous electrical nerve stimulation (TENS)
Transcutaneous electrical nerve stimulation (TENS)
Intervention: Transcutaneous electrical nerve stimulation (TENS) (Device)
Moderate IV Sedation
Fentanyl, versed
Intervention: Moderate IV Sedation (Drug)
Outcomes
Primary Outcomes
Aspiration Pain
Time Frame: 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 Outcomes
- Paracervical Block Pain(Intraoperative, collected during procedure (up to 30 seconds))
- Speculum Placement Pain(Intraoperative, collected during procedure (up to 30 seconds))
- Manual Cervical Dilation Pain(Intraoperative, collected during procedure (up to 30 seconds))
- Tenaculum Placement Pain(Intraoperative, collected during procedure (up to 30 seconds))
- Speculum Removal Pain(Intraoperative, collected during procedure (up to 30 seconds))
- Total Procedure Time(Intraoperative, collected during procedure (up to 20 minutes))