NCT03900728

Auriculotherapy During Medication Abortion

Auriculotherapy as an Adjunct for Pain Management During Medication Abortion: a Randomized, Double-blinded, Three-arm Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Abortion Early

Interventions

Type	Name	Description
DEVICE	Auriculotherapy with needles	Single-use 1.2mm acupuncture press needles attach to pre-specified acupoints on the participant's ears with adhesive disk/tape.
DEVICE	Auriculotherapy with beads	A trained co-investigator will place the beads onto prespecified acupoints of the participant's ears. An adhesive disk will adhere the beads to the ears.
DEVICE	Placebo Adhesive disks	Single-use adhesive disks without needles or beads.

Timeline

• Start date: 2019-04-01
• Primary completion: 2020-03-30
• Completion: 2020-03-30
• First posted: 2019-04-03
• Last updated: 2021-07-06
• Results posted: 2021-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study