Auriculotherapy - Pain Management of Aspiration Abortion

NCT03896022 | Completed Results FDA Device

• 1 other identifier: AAAS0917
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To assess whether usual care plus auricular acupressure with beads reduces subject-reported maximum pain during first trimester vacuum aspiration compared to usual care plus placebo. Secondary Objective: To assess whether usual care plus auricular acupuncture with Pyonex™ needles reduces subject-reported maximum pain during first trimester vacuum aspiration as compared to usual care plus placebo. This assessment will replicate the previous trial and strengthen the evidence that auricular acupuncture is beneficial for aspiration abortion pain Exploratory Objective: To assess whether usual care plus either auricular acupressure with beads or auricular acupuncture with Pyonex™ needles reduces subject-reported anxiety scores during first trimester vacuum aspiration as compared to women receiving usual care plus placebo.

Conditions

Abortion in First Trimester

Keywords

auriculotherapy; abortion; pain management

Outcome Measures

Primary Outcomes (1)

• Pain Visual Analog Scale Score (Beads vs Placebo)

  Self-assessed maximum pain reported using a 0-100mm visual analog scale, where 100 signifies maximum pain. To measure pain experienced during aspiration abortion.

  Immediately following the aspiration abortion procedure (approximately 10 minutes)

Secondary Outcomes (1)

• Pain Visual Analog Scale Score (Needles vs Placebo)

  Immediately following the aspiration abortion procedure (approximately 10 minutes)

Other Outcomes (1)

• Anxiety Visual Analog Scale Score

  Immediately following the aspiration abortion procedure (approximately 10 minutes)

Study Arms (3)

Auriculotherapy - Acupressure with Gold Beads

ACTIVE COMPARATOR

A designated trained auriculotherapy provider will place gold 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 during the aspiration abortion and will be removed before the participant is discharged home.

Device: Acupressure with Beads

Auriculotherapy - Acupuncture with Pyonex Needles

ACTIVE COMPARATOR

A designated trained auriculotherapy provider will place 1.2mm (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 during the aspiration abortion and will be removed before the participant is discharged home.

Device: Acupuncture with Needles

Placebo Group

SHAM COMPARATOR

A designated trained auriculotherapy provider 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 during the aspiration abortion and will be removed before the participant is discharged home.

Device: Placebo Adhesive Disks

Interventions

Acupressure with Beads DEVICE

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

Also known as: Accu-patch Pellets, Accu-patch Beads

Auriculotherapy - Acupressure with Gold Beads

Acupuncture 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, Seirin Pyonex Singles

Auriculotherapy - Acupuncture with Pyonex Needles

Placebo Adhesive Disks DEVICE

Single-use adhesive disks without needles or beads.

Also known as: Placebo Disks

Placebo Group

Eligibility Criteria

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

You may qualify if:

• Pregnant up to 13 weeks gestation
• Seeking aspiration abortion for any first trimester induced abortion, abnormal pregnancy, early pregnancy loss, retained products of conception, or molar pregnancy
• English- or Spanish-speaking
• Willingness to be randomized into one of the three arms.

You may not qualify if:

• Allergy to adhesives or gold
• Allergy or intolerance to ibuprofen or 1% lidocaine (paracervical block)
• Congenital anomaly or infection of the ear.

Sponsors & Collaborators

• Columbia University: lead
• Society of Family Planning: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

• 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

MeSH Terms

Conditions

Agnosia

Interventions

Acupressure; Acupuncture Therapy; Needles

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Equipment and Supplies

Results Point of Contact

• Title: Carolyn Westhoff, MD
• Organization: Columbia University

clw3@cumc.columbia.edu

212-305-4805

Study Officials

• Carolyn Westhoff, MD, MSc

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: A designated investigator (auriculotherapy provider) will apply the intervention prior to the aspiration abortion; thus the care provider (abortion provider) will not be aware of the treatment arm. Participant will wear a surgical hat that covers their ears and 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 of Obstetrics and Gynecology

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

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: March 29, 2019
• Study Start: March 28, 2019
• Primary Completion: December 12, 2019
• Study Completion: December 12, 2019
• Last Updated: February 9, 2021
• Results First Posted: January 22, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)