Auriculotherapy as an Adjunct for Pain Management During Medication Abortion: a Randomized, Double-blinded, Three-arm Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Abortion Early
- Sponsor
- Columbia University
- Enrollment
- 138
- Locations
- 1
- Primary Endpoint
- Pain VAS Score
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Carolyn Westhoff
Professor
Columbia University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Pain VAS Score
Time Frame: Auriculotherapy is applied on the day of mifepristone. Participants take misoprostol 1-3 days later. Pain scores are recorded following misoprostol at 8pm x 4 days (selecting the highest of the 4 for analysis).
Self-assessed maximum pain reported using a 0-100 mm visual analog scale (VAS), where 100 signifies maximum pain.
Secondary Outcomes
- Anxiety VAS Score(Auriculotherapy is applied on the day of mifepristone. Participants take misoprostol 1-3 days later. Anxiety scores are recorded following misoprostol at 8pm x 4 days (selecting the highest of 4 for analysis).)