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

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.

Study Overview

• Status: Completed
• Conditions: Abortion in First Trimester
• Intervention / Treatment: Device: Acupressure with Beads; Device: Acupuncture with Needles; Device: Placebo Adhesive Disks

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.

• Study Type: Interventional
• Enrollment (Actual): 177
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Auriculotherapy - Acupressure with Gold Beads; A designated trained auriculotherapy provider will place gold beads at five acupoints on each ear (10 points total). The beads are affixed with a small round adhesive disk. The beads will stay in place during the aspiration abortion and will be removed before the participant is discharged home.	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.; Other Names: Accu-patch Pellets; Accu-patch Beads
Active Comparator: Auriculotherapy - Acupuncture with Pyonex Needles; A designated trained auriculotherapy provider will place 1.2mm (Pyonex) needles at five acupoints on each ear (10 points total). The needles are affixed with a small round adhesive disk. The needles will stay in place during the aspiration abortion and will be removed before the participant is discharged home.	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.; Other Names: Pyonex Needles; Seirin Pyonex Singles
Sham Comparator: Placebo Group; A designated trained auriculotherapy provider will place adhesive disks at five acupoints on each ear (10 points total). The disks resemble those used with the active treatments. The disks will stay in place during the aspiration abortion and will be removed before the participant is discharged home.	Device: Placebo Adhesive Disks; Single-use adhesive disks without needles or beads.; Other Names: Placebo Disks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Visual Analog Scale Score (Beads vs Placebo)	Self-assessed maximum pain reported using a 0-100mm visual analog scale, where 100 signifies maximum pain. To measure pain experienced during aspiration abortion.	Immediately following the aspiration abortion procedure (approximately 10 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Visual Analog Scale Score (Needles vs Placebo)	Self-assessed maximum pain reported using a 0-100mm visual analog scale, where 100 signifies maximum pain. To measure pain experienced during aspiration abortion.	Immediately following the aspiration abortion procedure (approximately 10 minutes)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety Visual Analog Scale Score	Self-assessed maximum anxiety reported using a 0-100 mm visual analog scale, where 100 signifies maximum anxiety. To measure anxiety during aspiration abortion.	Immediately following the aspiration abortion procedure (approximately 10 minutes)

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Society of Family Planning

Publications and helpful links

General Publications

• Ndubisi C, Danvers A, Gold MA, Morrow L, Westhoff CL. Auricular acupuncture as an adjunct for pain management during first trimester abortion: a randomized, double-blinded, three arm trial. Contraception. 2019 Mar;99(3):143-147. doi: 10.1016/j.contraception.2018.11.016. Epub 2018 Dec 7.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2019
• Primary Completion (Actual): December 12, 2019
• Study Completion (Actual): December 12, 2019

Study Registration Dates

• First Submitted: March 27, 2019
• First Submitted That Met QC Criteria: March 28, 2019
• First Posted (Actual): March 29, 2019

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 5, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: abortion; pain management; auriculotherapy
• Other Study ID Numbers: AAAS0917

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes