N/A
N=177
Auriculotherapy - Pain Management of Aspiration Abortion
Abortion in First Trimester
Bottom Line
View on ClinicalTrials.gov: NCT03896022 ↗Enrolled (actual)
177
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Pain Visual Analog Scale Score (Beads vs Placebo) — 50; 47.5 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acupressure with Beads (Device); Acupuncture with Needles (Device); Placebo Adhesive Disks (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Columbia University
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Visual Analog Scale Score (Beads vs Placebo) |
50; 47.5 | — |
| SECONDARY Pain Visual Analog Scale Score (Needles vs Placebo) |
55; 47.5 | — |
Summary
Primary Objective: To assess whether usual care plus auricular acupressure with beads reduces subject-reported maximum pain during first trimester vacuum aspiration compared to usual care plus placebo.
Secondary Objective: To assess whether usual care plus auricular acupuncture with Pyonex™ needles reduces subject-reported maximum pain during first trimester vacuum aspiration as compared to usual care plus placebo. This assessment will replicate the previous trial and strengthen the evidence that auricular acupuncture is beneficial for aspiration abortion pain
Exploratory Objective: To assess whether usual care plus either auricular acupressure with beads or auricular acupuncture with Pyonex™ needles reduces subject-reported anxiety scores during first trimester vacuum aspiration as compared to women receiving usual care plus placebo.
Eligibility Criteria
bullets
Inclusion Criteria
- Pregnant up to 13 weeks gestation
- Seeking aspiration abortion for any first trimester induced abortion, abnormal pregnancy, early pregnancy loss, retained products of conception, or molar pregnancy
- English- or Spanish-speaking
- Willingness to be randomized into one of the three arms.
Exclusion Criteria
- Allergy to adhesives or gold
- Allergy or intolerance to ibuprofen or 1% lidocaine (paracervical block)
- Congenital anomaly or infection of the ear.
Data sourced from ClinicalTrials.gov (NCT03896022). 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.