N/A
N=136
Auriculotherapy During Medication Abortion
Abortion Early
Bottom Line
View on ClinicalTrials.gov: NCT03900728 ↗Enrolled (actual)
136
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Pain VAS Score — 75; 60; 55 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Auriculotherapy with needles (Device); Auriculotherapy with beads (Device); Placebo Adhesive disks (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Columbia University
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain VAS Score |
75; 60; 55 | — |
| SECONDARY Anxiety VAS Score |
45; 10; 30 | — |
Summary
This randomized trial will evaluate the effect of adding auriculotherapy (i.e. acupuncture applied to the ear) using either gold beads or Pyonex needles in addition to usual care for the relief of pain and anxiety during medication abortion. The control group will receive placebo auriculotherapy plus usual care. Participants will receive the assigned treatment immediately after they receive their initial abortion medication. The investigators will assess pain and anxiety via text message once daily for four days, and in person at a one-week follow-up visit.
Eligibility Criteria
Inclusion Criteria
- Pregnant up to 10 weeks (70 days) gestation
- Seeking medication abortion with mifepristone and misoprostol
- Initial clinical care completed and mifepristone administered
- English- or Spanish-speaking
- Able to use a mobile phone for follow-up on days 1-4
Exclusion Criteria
- Not a candidate for medication abortion for any reason
- Allergy to adhesives
Data sourced from ClinicalTrials.gov (NCT03900728). 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.