NCT03896022

Auriculotherapy - Pain Management of Aspiration Abortion

Auriculotherapy as an Adjunct for Pain Management During First Trimester Vacuum Aspiration Abortion: a Randomized, Double-blinded, Three Arm Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 177 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Most first trimester aspiration abortions are performed in the outpatient setting with a paracervical block and nonsteroidal anti-inflammatory drugs (NSAIDs) as the only analgesics. Yet first trimester aspiration pain control is often inadequate with 26-32% of women reporting that they experienced severe pain. Moderate sedation and general anesthesia are not readily available, and investigations on opioids and anxiolytics have consistently found them ineffective for first trimester aspiration abortion pain. In 2018, The National Academies of Sciences, Engineering, and Medicine (NASEM) recommended research to improve pain relief. Limited data indicate that acupuncture is valuable in dysmenorrhea and for labor pain, conditions in which pain may be similar to that experienced during aspiration abortion. This randomized trial will recruit women seeking first trimester aspiration abortion. This study will evaluate two types of auriculotherapy applied to selected acupoints on the external ear. The study treatments are acupressure using gold beads and acupuncture using Pyonex needles; both are applied to the ear using adhesive disks. A control group will receive the adhesive disks alone. All participants will receive usual care for their aspiration abortion procedure, including a paracervical block and ibuprofen for pain management. The investigators will query the participants regarding pain and anxiety immediately after their procedure, in person, on the day of their procedure.

Conditions

• Abortion in First Trimester

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-03-28
• Primary completion: 2019-12-12
• Completion: 2019-12-12
• First posted: 2019-03-29
• Last updated: 2021-02-09
• Results posted: 2021-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study