Abortion Early Clinical Trial
Official title:
Auriculotherapy as an Adjunct for Pain Management During Medication Abortion: a Randomized, Double-blinded, Three-arm Trial
NCT number | NCT03900728 |
Other study ID # | AAAS2520 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2019 |
Est. completion date | March 30, 2020 |
Verified date | June 2021 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 138 |
Est. completion date | March 30, 2020 |
Est. primary completion date | March 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University |
United States,
Ndubisi C, Danvers A, Gold MA, Morrow L, Westhoff CL. Auricular acupuncture as an adjunct for pain management during first trimester abortion: a randomized, double-blinded, three arm trial. Contraception. 2019 Mar;99(3):143-147. doi: 10.1016/j.contraception.2018.11.016. Epub 2018 Dec 7. — View Citation
Westhoff CL, Nelson IS, Suarez-Rodriguez A, Gold MA. Auricular acupressure and acupuncture as adjuncts for pain management during first trimester medication abortion: A randomized three-arm trial. Contraception. 2021 May;103(5):348-355. doi: 10.1016/j.con — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain VAS Score | Self-assessed maximum pain reported using a 0-100 mm visual analog scale (VAS), where 100 signifies maximum pain. | 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). | |
Secondary | Anxiety VAS Score | Self-assessed maximum anxiety reported using a 0-100 mm visual analog scale, where 100 signifies maximum anxiety. | 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). |
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