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Completed

NCT Number: NCT03900728

Auriculotherapy During Medication Abortion

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.

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Key information

Conditions

Abortion Early

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auriculotherapy with needles

Device

Single-use 1.2mm acupuncture press needles attach to pre-specified acupoints on the participant's ears with adhesive disk/tape.

Other names: Pyonex needles

Auriculotherapy with beads

Device

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.

Other names: Single-use gold-plated 1.2mm beads/balls attach to pre-specified acupoints on the participant's ears with adhesive disk/tape.

Placebo Adhesive Disks

Device

Single-use adhesive disks without needles or beads.

Other names: Placebo disks

Primary outcomes

  1. 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

  1. Anxiety VAS Score

    Time frame: 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).

    Self-assessed maximum anxiety reported using a 0-100 mm visual analog scale, where 100 signifies maximum anxiety.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 3, 2019
Registry last updated
Jul 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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