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Auriculotherapy - Pain Management of Aspiration Abortion

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ClinicalTrials.gov Identifier: NCT03896022
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : May 24, 2019
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Carolyn L. Westhoff, Columbia University

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.


Condition or disease Intervention/treatment Phase
Abortion in First Trimester Device: Acupressure with Beads Device: Acupuncture with Needles Device: Placebo Adhesive Disks Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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).
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Supportive Care
Official Title: Auriculotherapy as an Adjunct for Pain Management During First Trimester Vacuum Aspiration Abortion: a Randomized, Double-blinded, Three Arm Trial
Actual Study Start Date : March 28, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Auriculotherapy - Acupressure with Gold Beads
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
Single-use gold-plated 1.2mm beads/balls attach to pre-specified acupoints on the participant's ears with adhesive disk/tape.
Other Names:
  • Accu-patch Pellets
  • Accu-patch Beads

Active Comparator: Auriculotherapy - Acupuncture with Pyonex Needles
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
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
  • Seirin Pyonex Singles

Sham Comparator: Placebo Group
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
Single-use adhesive disks without needles or beads.
Other Name: Placebo Disks




Primary Outcome Measures :
  1. Pain visual analog scale score (beads vs placebo) [ Time Frame: Immediately following the aspiration abortion procedure (approximately 10 minutes) ]
    Self-assessed maximum pain reported using a 0-100mm visual analog scale, where 100 signifies maximum pain. To measure pain experienced during aspiration abortion.


Secondary Outcome Measures :
  1. Pain visual analog scale score (needles vs placebo) [ Time Frame: Immediately following the aspiration abortion procedure (approximately 10 minutes) ]
    Self-assessed maximum pain reported using a 0-100mm visual analog scale, where 100 signifies maximum pain. To measure pain experienced during aspiration abortion.


Other Outcome Measures:
  1. Anxiety visual analog scale score [ Time Frame: Immediately following the aspiration abortion procedure (approximately 10 minutes) ]
    Self-assessed maximum anxiety reported using a 0-100 mm visual analog scale, where 100 signifies maximum anxiety. To measure anxiety during aspiration abortion.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

bullets

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896022


Contacts
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Contact: Carolyn Westhoff, MD, MSc 212-305-4805 clw3@columbia.edu
Contact: Johana Oviedo, MD, MPH 212-305-4938 jdo2120@cumc.columbia.edu

Locations
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United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Carolyn Westhoff, MD, MSc       clw3@cumc.columbia.edu   
Contact: Johana Oviedo, MD, MPH       jdo2120@cumc.columbia.edu   
Principal Investigator: Carolyn Westhoff, MD, MSc         
Sponsors and Collaborators
Columbia University
Society of Family Planning
Investigators
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Principal Investigator: Carolyn Westhoff, MD, MSc Columbia University

Publications:
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Responsible Party: Carolyn L. Westhoff, Professor of Obstetrics and Gynecology, Columbia University
ClinicalTrials.gov Identifier: NCT03896022     History of Changes
Other Study ID Numbers: AAAS0917
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Carolyn L. Westhoff, Columbia University:
auriculotherapy
abortion
pain management