Auriculotherapy - Pain Management of Aspiration Abortion

• Sponsor: Columbia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03896022
• Collaborator: Society of Family Planning (Other)
• Enrollment: 177
• Location: 1
• Arms: 3
• Actual Duration (Months): 8.5
• Patients Per Site Per Month: 20.8

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 177 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).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: Mar 28, 2019
• Actual Primary Completion Date: Dec 12, 2019
• Actual Study Completion Date: Dec 12, 2019

Arms and Interventions

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 Names: Placebo Disks

Outcome Measures

Primary Outcome Measures

1. Pain Visual Analog Scale Score (Beads vs Placebo) [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) [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia University Medical Center	New York	New York	United States	10032

Sponsors and Collaborators

• Columbia University
• Society of Family Planning

Investigators

• Principal Investigator: Carolyn Westhoff, MD, MSc, Columbia University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 5, 2018

More Information

Publications

• 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.

• Responsible Party: Carolyn Westhoff, Professor of Obstetrics and Gynecology, Columbia University
• ClinicalTrials.gov Identifier: NCT03896022
• Other Study ID Numbers: AAAS0917
• First Posted: Mar 29, 2019
• Last Update Posted: Feb 9, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Carolyn Westhoff, Professor of Obstetrics and Gynecology, Columbia University: auriculotherapy; abortion; pain management

Study Results

Participant Flow

Pre-assignment Detail	177 participants were randomized. 4 participants were excluded from the acupressure group (1 withdrew from the study after randomization and 3 did not have a procedure that day). The final analysis included 173 participants: 70 participants in the acupressure group, 51 in the acupuncture group, and 52 in the placebo group.

Arm/Group Title	Auriculotherapy - Acupressure With Gold Beads	Auriculotherapy - Acupuncture With Pyonex Needles	Placebo Group
Arm/Group Description	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. 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.	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. Acupuncture with Needles: Single-use 1.2mm acupuncture press needles attach to pre-specified acupoints on the participant's ears with adhesive disk/tape.	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. Placebo Adhesive Disks: Single-use adhesive disks without needles or beads.
Period Title: Overall Study
STARTED	74	51	52
COMPLETED	70	51	52
NOT COMPLETED	4	0	0

Baseline Characteristics

Arm/Group Title	Auriculotherapy - Acupressure With Gold Beads	Auriculotherapy - Acupuncture With Pyonex Needles	Placebo Group	Total
Arm/Group Description	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. 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.	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. Acupuncture with Needles: Single-use 1.2mm acupuncture press needles attach to pre-specified acupoints on the participant's ears with adhesive disk/tape.	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. Placebo Adhesive Disks: Single-use adhesive disks without needles or beads.	Total of all reporting groups
Overall Participants	70	51	52	173
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.4 (6.6)	31.5 (6.2)	30.3 (6.2)	31.1 (6.4)
Sex: Female, Male (Count of Participants)
Female	70 100%	51 100%	52 100%	173 100%
Male	0 0%	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
Hispanic	55 78.6%	33 64.7%	42 80.8%	130 75.1%
Non-Hispanic White	4 5.7%	4 7.8%	4 7.7%	12 6.9%
Non-Hispanic Black	8 11.4%	9 17.6%	2 3.8%	19 11%
Other (Asian)	3 4.3%	5 9.8%	2 3.8%	10 5.8%
Unknown	0 0%	0 0%	2 3.8%	2 1.2%
Region of Enrollment (Count of Participants)
United States	70 100%	51 100%	52 100%	173 100%

Outcome Measures

1. Primary Outcome

Title	Pain Visual Analog Scale Score (Beads vs Placebo)
Description	Self-assessed maximum pain reported using a 0-100mm visual analog scale, where 100 signifies maximum pain. To measure pain experienced during aspiration abortion.
Time Frame	Immediately following the aspiration abortion procedure (approximately 10 minutes)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Auriculotherapy - Acupressure With Gold Beads	Placebo Group
Arm/Group Description	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. 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.	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. Placebo Adhesive Disks: Single-use adhesive disks without needles or beads.
Measure Participants	70	52
Median (Inter-Quartile Range) [score on a scale]	50	47.5

2. Secondary Outcome

Title	Pain Visual Analog Scale Score (Needles vs Placebo)
Description	Self-assessed maximum pain reported using a 0-100mm visual analog scale, where 100 signifies maximum pain. To measure pain experienced during aspiration abortion.
Time Frame	Immediately following the aspiration abortion procedure (approximately 10 minutes)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Auriculotherapy - Acupuncture With Pyonex Needles	Placebo Group
Arm/Group Description	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. Acupuncture with Needles: Single-use 1.2mm acupuncture press needles attach to pre-specified acupoints on the participant's ears with adhesive disk/tape.	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. Placebo Adhesive Disks: Single-use adhesive disks without needles or beads.
Measure Participants	51	52
Median (Inter-Quartile Range) [score on a scale]	55	47.5

3. Other Pre-specified Outcome

Title	Anxiety Visual Analog Scale Score
Description	Self-assessed maximum anxiety reported using a 0-100 mm visual analog scale, where 100 signifies maximum anxiety. To measure anxiety during aspiration abortion.
Time Frame	Immediately following the aspiration abortion procedure (approximately 10 minutes)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Auriculotherapy - Acupressure With Gold Beads	Auriculotherapy - Acupuncture With Pyonex Needles	Placebo Group
Arm/Group Description	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. 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.	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. Acupuncture with Needles: Single-use 1.2mm acupuncture press needles attach to pre-specified acupoints on the participant's ears with adhesive disk/tape.	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. Placebo Adhesive Disks: Single-use adhesive disks without needles or beads.
Measure Participants	70	51	52
Median (Inter-Quartile Range) [score on a scale]	26	28	21

Adverse Events

Time Frame	During and immediately following the aspiration abortion procedure (approximately 10 minutes).
Arm/Group Title	Auriculotherapy - Acupressure With Gold Beads		Auriculotherapy - Acupuncture With Pyonex Needles		Placebo Group
Arm/Group Description	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. 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.		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. Acupuncture with Needles: Single-use 1.2mm acupuncture press needles attach to pre-specified acupoints on the participant's ears with adhesive disk/tape.		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. Placebo Adhesive Disks: Single-use adhesive disks without needles or beads.
All Cause Mortality
	Auriculotherapy - Acupressure With Gold Beads		Auriculotherapy - Acupuncture With Pyonex Needles		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/70 (0%)		0/51 (0%)		0/52 (0%)
Serious Adverse Events
	Auriculotherapy - Acupressure With Gold Beads		Auriculotherapy - Acupuncture With Pyonex Needles		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/70 (0%)		0/51 (0%)		0/52 (0%)
Other (Not Including Serious) Adverse Events
	Auriculotherapy - Acupressure With Gold Beads		Auriculotherapy - Acupuncture With Pyonex Needles		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/70 (0%)		0/51 (0%)		0/52 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.