N/A
N=74
Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Control During Cervical Dilator Placement Prior to Dilation and Evacuation
Pain Management
Bottom Line
View on ClinicalTrials.gov: NCT03868787 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Pain Following Dilator Placement — 64; 60.5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TENS (Device); Sham TENS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ashley Turner, MD
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Following Dilator Placement |
64; 60.5 | — |
| SECONDARY Interval Pain |
39; 55 | — |
| SECONDARY Patient Satisfaction |
4; 3; 5; 4; 2; 4 | — |
Summary
This study evaluates the use of Transcutaneous Electrical Nerve Stimulation (TENS) as a method of pain control during osmotic dilator insertion prior to dilation and evacuation. Half the group will have an active TENS unit and half will have a sham or placebo TENS unit.
Eligibility Criteria
Inclusion Criteria
- Women ≥ 18 years of age
- Gestational age between 14 weeks and 23 weeks 6 days
- Willing and able to sign an informed consent in English
- No contraindications to TENS
Exclusion Criteria
- Incarceration
- Preterm Premature Rupture of Membranes or evidence of intra-amniotic infection
- Presence of implanted cardiac device
- Lack of sensation to touch on area of electrode placement
- Prior TENS use
- Opioid dependence
Data sourced from ClinicalTrials.gov (NCT03868787). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.