Auriculotherapy During Medication Abortion

NCT03900728 | Completed Results FDA Device

• 1 other identifier: AAAS2520
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Abortion Early

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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).

Study Arms (3)

Auriculotherapy with needles (acupuncture) + usual care

ACTIVE COMPARATOR

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

Device: Auriculotherapy with needles

Auriculotherapy with gold beads (acupressure) + usual care

ACTIVE COMPARATOR

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.

Device: Auriculotherapy with beads

Placebo group + usual care

SHAM COMPARATOR

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.

Device: Placebo Adhesive disks

Interventions

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.

Also known as: Pyonex needles

Auriculotherapy with needles (acupuncture) + usual care

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.

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

Auriculotherapy with gold beads (acupressure) + usual care

Placebo Adhesive disks DEVICE

Single-use adhesive disks without needles or beads.

Also known as: Placebo disks

Placebo group + usual care

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (2)

• 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.

  PMID: 30529393 BACKGROUND

• 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.contraception.2020.12.003. Epub 2020 Dec 17.

  PMID: 33340496 RESULT

MeSH Terms

Interventions

Auriculotherapy; Needles

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Equipment and Supplies

Results Point of Contact

• Title: Carolyn Westhoff, MD
• Organization: Columbia University Irving Medical Center

clw3@cumc.columbia.edu

2123057070

Study Officials

• Carolyn Westhoff, MD

  Coumbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A separate investigator will apply the intervention after the initial usual care is complete and participants will go home using the intervention; thus the care provider will not be aware of the treatment. The adhesive disks appear similar for the treatments and the placebo arm; thus the participants will be unaware of their treatment assignment. The research assistant collecting the outcomes data will not know which treatment arm the participant belongs to. Finally, treatment assignment will be coded in the study database until analysis is complete, so that the investigator will be unaware of the treatment assignment until analysis is complete and then un-blinding will occur.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This 3-arm randomized trial will assign participants 1:1:1 to receive either of two active treatments (acupuncture or acupressure) or placebo (insert adhesive disks applied to ears).

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: April 3, 2019
• Study Start: April 1, 2019
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: July 6, 2021
• Results First Posted: April 15, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available after acceptance of main study outcome paper for publication.
• Access Criteria: By personal contact with PI

Locations

US (1)