Auriculotherapy - Pain Management of Aspiration Abortion
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/31/2019 |
| Start Date: | April 2019 |
| End Date: | June 2020 |
| Contact: | Carolyn Westhoff, MD, MSc |
| Email: | clw3@columbia.edu |
| Phone: | 212-305-4805 |
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.
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.
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.
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.
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.
We found this trial at
1
site
630 W 168th St
New York, New York
New York, New York
212-305-2862
Principal Investigator: Carolyn Westhoff, MD, MSc
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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