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Auriculotherapy - Pain Management of Aspiration Abortion

NCT03896022 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2021-02-09

Study results available
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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.

Conditions

  • Abortion in First Trimester

Interventions

DEVICE

Acupressure with Beads

Single-use gold-plated 1.2mm beads/balls attach to pre-specified acupoints on the participant's ears with adhesive disk/tape.

DEVICE

Acupuncture with Needles

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

DEVICE

Placebo Adhesive Disks

Single-use adhesive disks without needles or beads.

Sponsors & Collaborators

Principal Investigators

  • Carolyn Westhoff, MD, MSc · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-28
Primary Completion
2019-12-12
Completion
2019-12-12
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 NCT03896022 on ClinicalTrials.gov