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Auriculotherapy During Medication Abortion

NCT03900728 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2021-07-06

Study results available
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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.

Conditions

  • Abortion Early

Interventions

DEVICE

Auriculotherapy with needles

Single-use 1.2mm acupuncture press needles attach to pre-specified acupoints on the participant's ears with adhesive disk/tape.

DEVICE

Auriculotherapy with beads

A trained co-investigator will place the beads onto prespecified acupoints of the participant's ears. An adhesive disk will adhere the beads to the ears.

DEVICE

Placebo Adhesive disks

Single-use adhesive disks without needles or beads.

Sponsors & Collaborators

Principal Investigators

  • Carolyn Westhoff, MD · Coumbia University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2020-03-30
Completion
2020-03-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03900728 on ClinicalTrials.gov