Auriculotherapy - Pain Management of Aspiration Abortion

Abortion in First Trimester Clinical Trial

Official title:

Auriculotherapy as an Adjunct for Pain Management During First Trimester Vacuum Aspiration Abortion: a Randomized, Double-blinded, Three Arm Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03896022
• Other study ID #: AAAS0917
• Status: Completed
• Phase: N/A
• Start date: March 28, 2019
• Est. completion date: December 12, 2019

Study information

• Verified date: February 2021
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Most first trimester aspiration abortions are performed in the outpatient setting with a paracervical block and nonsteroidal anti-inflammatory drugs (NSAIDs) as the only analgesics. Yet first trimester aspiration pain control is often inadequate with 26-32% of women reporting that they experienced severe pain. Moderate sedation and general anesthesia are not readily available, and investigations on opioids and anxiolytics have consistently found them ineffective for first trimester aspiration abortion pain. In 2018, The National Academies of Sciences, Engineering, and Medicine (NASEM) recommended research to improve pain relief. Limited data indicate that acupuncture is valuable in dysmenorrhea and for labor pain, conditions in which pain may be similar to that experienced during aspiration abortion. This randomized trial will recruit women seeking first trimester aspiration abortion. This study will evaluate two types of auriculotherapy applied to selected acupoints on the external ear. The study treatments are acupressure using gold beads and acupuncture using Pyonex needles; both are applied to the ear using adhesive disks. A control group will receive the adhesive disks alone. All participants will receive usual care for their aspiration abortion procedure, including a paracervical block and ibuprofen for pain management. The investigators will query the participants regarding pain and anxiety immediately after their procedure, in person, on the day of their procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: December 12, 2019
• Est. primary completion date: December 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Abortion in First Trimester

Intervention

Device:
• Acupressure with Beads
Single-use gold-plated 1.2mm beads/balls attach to pre-specified acupoints on the participant's ears with adhesive disk/tape.
• Acupuncture with Needles
Single-use 1.2mm acupuncture press needles attach to pre-specified acupoints on the participant's ears with adhesive disk/tape.
• Placebo Adhesive Disks
Single-use adhesive disks without needles or beads.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Society of Family Planning

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anxiety Visual Analog Scale Score	Self-assessed maximum anxiety reported using a 0-100 mm visual analog scale, where 100 signifies maximum anxiety. To measure anxiety during aspiration abortion.	Immediately following the aspiration abortion procedure (approximately 10 minutes)
Primary	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	Pain Visual Analog Scale Score (Needles 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)