Clinical trial NCT03896022: Auriculotherapy - Pain Management of Aspiration Abortion
Official title: Auriculotherapy as an Adjunct for Pain Management During First Trimester Vacuum Aspiration Abortion: a Randomized, Double-blinded, Three Arm Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion in First Trimester
Keywords: auriculotherapy
abortion
pain management
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2019-03-29
Enrollment: 177
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This 3-arm randomized trial will assign participants 1:1:1 to receive either of two active treatments (acupressure or acupuncture) or placebo (inert adhesive disks applied to ears).
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Primary outcomes:
measure: Pain Visual Analog Scale Score (Beads vs Placebo)
timeFrame: Immediately following the aspiration abortion procedure (approximately 10 minutes)
Secondary outcomes:
measure: Pain Visual Analog Scale Score (Needles vs Placebo)
timeFrame: Immediately following the aspiration abortion procedure (approximately 10 minutes)
Other outcomes:
measure: Anxiety Visual Analog Scale Score
timeFrame: Immediately following the aspiration abortion procedure (approximately 10 minutes)
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Carolyn Westhoff, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.