Auriculotherapy During Medication Abortion

Columbia University

Status: Completed

Conditions: Abortion Early

Treatments: Device: Auriculotherapy with needles; Device: Placebo Adhesive disks; Device: Auriculotherapy with beads

Study type: Interventional

Funder types: Other

Identifiers

NCT03900728

AAAS2520

Details and patient eligibility

About

This randomized trial will evaluate the effect of adding auriculotherapy (i.e. acupuncture applied to the ear) using either gold beads or Pyonex needles in addition to usual care for the relief of pain and anxiety during medication abortion. The control group will receive placebo auriculotherapy plus usual care. Participants will receive the assigned treatment immediately after they receive their initial abortion medication. The investigators will assess pain and anxiety via text message once daily for four days, and in person at a one-week follow-up visit.

Full description

Most women undergoing medication abortion with mifepristone and misoprostol report moderate to severe pain, despite treatment with ibuprofen or opioids. In 2018 National Academies of Sciences, Engineering and Medicine (NASEM) recommended research to improve pain relief. Limited data indicate that acupuncture is valuable for dysmenorrhea and for labor pain, conditions in which pain may be similar to that experienced during medication abortion. This randomized trial will recruit women seeking medication abortion after they have completed their routine clinical assessment and after they have received mifepristone. This study will evaluate two types of auriculotherapy applied to selected acupoints on the external ear. The study treatments are acupuncture using Pyonex needles and acupressure using gold pellets; both are applied to the ear using adhesive disks. A control group will receive the adhesive disks alone. All participants will receive usual medication abortion care, including taking misoprostol 1-3 days after mifepristone and ibuprofen for pain management. The investigators will query the participants regarding pain and anxiety. Follow-up will end at the time of the usual clinical follow-up about one week after mifepristone administration.

Enrollment: 138 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant up to 10 weeks (70 days) gestation
• Seeking medication abortion with mifepristone and misoprostol
• Initial clinical care completed and mifepristone administered
• English- or Spanish-speaking
• Able to use a mobile phone for follow-up on days 1-4

Exclusion criteria

• Not a candidate for medication abortion for any reason
• Allergy to adhesives

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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138 participants in 3 patient groups

Auriculotherapy with needles (acupuncture) + usual care

Active Comparator group

Description:

A designated trained therapist will perform auriculotherapy with 1mm (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 until removal at the 1-week follow-up visit

Treatment:

Device: Auriculotherapy with needles

Auriculotherapy with gold beads (acupressure) + usual care

Active Comparator group

Description:

A designated trained therapist will perform auriculotherapy with 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 until removal at the 1-week follow-up visit.

Treatment:

Device: Auriculotherapy with beads

Placebo group + usual care

Sham Comparator group

Description:

A designated trained therapist 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 until removal at the 1-week follow-up visit.

Treatment:

Device: Placebo Adhesive disks