Auriculotherapy as an Adjunct for Pain Management During First Trimester Vacuum Aspiration Abortion: a Randomized, Double-blinded, Three Arm Trial
Phase: NA
Conditions: Abortion in First Trimester
Sponsor: Columbia University

NCT03896022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Auriculotherapy for Pain Management of First Trimester Surgical Abortion 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Johana D. Oviedo, MD, MPH 
Carolyn L. Westhoff, MD, MSc 
Melanie A. Gold, DO, DABMA, DMQ 
Columbia University 
Version: December 5, 2018 
Auriculotherapy (Oviedo): Fellowship in Family Planning Research Proposal 

PROJECT SUMMARY 
 
Of the 638,169 abortions performed in 2015, 91.1 % were ≤13 weeks gestation (Jatlaoui, 2018). 
Many first trimester vacuum aspirations are performed in the outpatient setting with a 
paracervical block and nonsteroidal anti-inflammatory drugs (NSAIDs) as the only analgesics, 
but this is often inadequate. Moderate sedation and general anesthesia are not readily 
available (O’Connell, 2009; White, 2018). In addition, opioids and anxiolytics do not improve 
pain control (Micks, 2012; Bayer, 2015). This year, the National Academy of Sciences’ 
published “The Safety and Quality of Abortion Care in the U.S.” highlighting the existing 
research gap in optimizing pain management during aspiration procedures (National Academy of 
Sciences, 2018). This prompts us to look at non-pharmacologic approaches to pain management. 
In our division, auricular acupuncture using Pyonex™ needles, as an adjunct to paracervical 
block and ibuprofen (usual care), substantially lowered pain and anxiety scores, compared to 
pain and anxiety in a randomized trial of women assigned to placebo with usual care or usual 
care alone during first-trimester vacuum aspiration (Ndubisi, 2018). This finding was promising 
and it is the only published study that looks at auricular acupuncture in abortion pain 
management. Given varying state restrictions, however, provision of acupuncture with needles 
is limited (Lin, 2017). Auricular acupressure with seeds or beads showed labor pain reduction 
and may prove to be an effective alternative to vacuum aspiration pain management (Smith, 
2011). Acupressure is not regulated to the extent that acupuncture is given that the skin is not 
penetrated. There are no studies, however, looking acupressure in abortion pain management. 
We propose a randomized, double-blinded, three-arm trial to assess maximum pain and anxiety 
scores during first trimester vacuum aspiration using a 100 mm visual analog scale in a total of 
141 participants randomized to either (1) auricular acupressure with beads plus usual care, (2) 
auricular acupuncture with PyonexTM needles plus usual care, or (3) placebo plus usual care. 
The goal of this study is to test the hypothesis that auricular acupressure with seeds, in addition 
to usual care with paracervical block and ibuprofen (an NSAID) will minimize pain during first 
trimester vacuum aspiration. We also aim to validate the findings of the previously mentioned 
acupuncture study. 
 
Primary Hypothesis: The median subject-reported maximum pain score, measured using a 
100mm VAS, among women receiving usual care plus auricular acupressure with beads, will be 
at least 20mm less than the women receiving usual care plus placebo. 
 
Secondary Hypothesis: The median subject-reported maximum pain score, measured using a 
100mm VAS, among women receiving usual care plus auricular acupuncture with PyonexTM 
needles, will be at least 20mm less than the women receiving usual care plus placebo. 
 
1. DESCRIPTION OF THE PROJECT 
 
1.1 Rationale and objectives of the study 
 
1.1.1 Rationale 
In the United States, approximately 926,200 abortions were performed in 2014 (Guttmacher, 
2018), and 91.5% of those occurred at ≤13 weeks gestation (Jatlaoui, 2017). The CDC reports 
that 638,169 abortions were performed in 2015 and that 91.1% were performed at ≤13 weeks’ 

gestation (Jatlaoui, 2018). Many first trimester vacuum aspirations are performed in the 
outpatient setting with a paracervical block and nonsteroidal anti-inflammatory drugs (NSAIDs) 
as the only analgesics, since moderate sedation and general anesthesia may be too expensive 
or not readily available (O’Connell, 2009; White, 2018). First trimester vacuum aspiration pain 
control is often inadequate as 26% to 32% of women report severe pain (Renner, 2010). This 
year, the National Academy of Sciences’ published “The Safety and Quality of Abortion Care in 
the U.S.” highlighting the existing research gap in optimizing pain management during 
aspiration procedures (National Academy of Sciences, 2018). Opioids and other anxiolytic 
medications, for first trimester vacuum aspirations, do not improve pain control (Micks, 2012; 
Bayer, 2015). Unnecessarily dispensing these medications can contribute to the opioid 
epidemic. Additionally, the effectiveness of non-pharmacological approaches (i.e. relaxation 
techniques, doulas) to reducing pain during first trimester vacuum aspiration is inconclusive 
(National Academy of Sciences, 2018; Tschann, 2018; Moayedi, 2018). 
 
Non-pharmacological approaches are worth considering as we seek to identify better 
approaches to minimize the pain women experience during an aspiration procedures. 
Auriculotherapy is an acupuncture modality that uses acupuncture points on the external ear 
(Oleson, 2014). Battlefield acupuncture (BFA), is a type of auriculotherapy created by Richard 
Niemtzow, MD, a US Air Force Colonel, with the goal of delivering rapid pain relief in the 
military battlefield (Oleson, 2014, Niemtzow, 2018) (See Appendix A). 
 
In our division, auricular acupuncture using Pyonex™ needles, as an adjunct to paracervical 
block and ibuprofen (usual care), substantially lowered pain and anxiety scores, compared to 
pain and anxiety in a randomized trial of women assigned to placebo with usual care or usual 
care alone during first-trimester vacuum aspiration. When measured on a 100 mm visual analog 
scale (VAS), the acupuncture, placebo, and usual care alone groups had a pain score of 39, 70, 
and 71mm respectively. Anxiety scores were 11.5, 31.0 and 44.0, respectively (Ndubisi, 2018). 
That study utilized the Gold protocol, a modified BFA protocol that included cervix and uterus 
acupoints (see Appendix B). The Gold protocol was created by Melanie Gold, DO, DABMA, 
DMQ, a physician-acupuncturist board-certified in Medical Acupuncture and one of my 
research mentors. 
 
These finding are promising because this modality can improve the quality of first trimester 
abortion care. BFA and the Gold protocol can be easily taught. Needle placement takes 
approximately three minutes and does not require a licensed acupuncturist. The Uniformed 
Services University of the Health Sciences (USUHS), a United States military medial school 
teaches BFA in two 2-hour sessions (Leggit, 2014). A 2016 case series describes 4 cases in 
which emergency physicians with 1 hour of BFA training performed BFA to treat patients with 
acute pain when opioid analgesia was not an acceptable option. Those four patients initially 
reported pain scores of 5 – 8 on a 10 point Numeric Pain Rating Scale; after 1 hour of BFA, 
repeat pain scores were 0 – 4 (Tsai, 2016). State regulations may pose a barrier in the provision 
of acupuncture (with needles) in the clinical setting. New York, for example, requires 300 hours 
of training for physicians and over 3,000 for nurses to be allowed to provide acupuncture (Lin, 
2017). Therefore, access to acupuncture for pain management in abortion would be limited in 
many states. Acupressure with seeds or beads, if similarly effective, may prove to be a useful 

alternative, given that such stringent training is not required since this modality does not 
puncture the skin. 
 
Little evidence exists on auriculotherapy effectiveness in vacuum aspiration abortion pain 
management with only one published study regarding auricular acupuncture, and no studies 
regarding acupressure (Ndubisi, 2018). A few studies have found that transcutaneous acupoint 
electrical stimulation (TEAS) or transcutaneous electrical nerve stimulation (TENS) is associated 
with analgesic effects, however these studies have been small, have lacked a control group, or 
have evaluated participants who also received IV sedation or general anesthesia (Wang, 2018; 
Feng, 2016, Platon 2010) (see section 1.2 for additional details on previous similar studies). 
Auricular acupressure showed significant pain reduction in labor in a systematic review with a 
small number of trials and high heterogeneity, but it may prove to be an effective alternative in 
pain management of first trimester vacuum aspiration (Smith, 2011). In a review of the effect of 
auricular acupressure on pain, 12 of 15 randomized controlled trials showed an improvement of 
pain, but study quality was variable (You, 2018). If auricular acupressure with beads proves to 
reduce pain during first trimester vacuum aspirations similar to auricular acupuncture with 
Pyonex™ needles, acupressure has the potential to be more widely used for its analgesic and 
anxiolytics effects because its use would not require extensive training or certification, such 
that any personnel could administer this modality. 
 
1.1.2 Objectives and hypotheses 
 
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. 
Hypothesis: The median subject-reported maximum pain score, measured using a 100mm VAS, 
among women receiving usual care plus auricular acupressure with beads, will be at least 
20mm less than the women receiving usual care plus placebo. 
 
Secondary Objective: 
To assess whether usual care plus auricular acupuncture with PyonexTM 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. . 
Hypothesis: The median subject-reported maximum pain score, measured using a 100mm VAS, 
among women receiving usual care plus auricular acupuncture with PyonexTM needles, will be 
at least 20mm less than the women receiving usual care plus placebo. 
 
Exploratory Objective: 
To assess whether usual care plus either auricular acupressure with beads OR auricular 
acupuncture with PyonexTM needles reduces subject-reported anxiety scores during first 
trimester vacuum aspiration as compared to women receiving usual care plus placebo. 
 
1.2 Previous similar studies 
 
Studies evaluating acupuncture during abortion procedures are few. A literature review 

revealed eight studies, two of which were conducted 25-35 years ago (Ai, 2018; Wang, 2018; 
Chen, 2017; Feng, 2016; Cheng, 2010; Platon 2010, Serfaty 1979, Ying 1985). In reviewing the 
abstract of the two studies conducted 25-35 years ago, the sample size range was 20-25 
participants and investigators evaluated the use of acupuncture for cervical preparation for first 
trimester abortions and effectiveness with pain management (Serfaty 1979, Ying 1985). 
However, the full articles are not yet available from the library; further knowledge about 
methods and results is unknown at this time. 
 
Several of the more recent studies with 30-40 participants per comparison group, only had 
abstracts available as well. Transcutaneous acupoint electrical stimulation (TEAS) resulted in 
lower VAS scores compared to nothing for medication abortion (Ai, 2018) and paracervical 
block with lidocaine for surgical abortion pain management (Chen, 2017). In one study there 
were no significant differences in VAS scores when TEAS was compared to a paracervical block 
(Cheng, 2010). 
 
The remaining three studies used transcutaneous electrical nerve stimulation (TENS) or TEAS. 
TEAS combines TENS and traditional acupuncture therapy. In TEAS and TENS, electrodes are 
placed over body acupoints and the electrical current is given to participants at an intensity 
range of 0-60 mA (Feng 2016, Platon 2010). In 2010, Platon et al, performed a RCT with 200 
women who underwent surgical abortion (under general propofol anesthesia) and compared 
the pain relieving effect after treatment with TENS or IV conventional pharmacological 
treatment (fentanyl) in the postoperative period. Women with a VAS ≥3 postoperatively were 
included in the study. The treatment groups were similar with regard to post-procedure pain 
(TENS = VAS 1.3 vs IV opioids = VAS 1.6), requesting additional analgesics, and VAS pain 
scores upon discharge from the hospital (TENS = 2.0 vs IV opioids = 1.8) (Platon, 2010). 
A 2016 cohort study of 140 nulliparous women, evaluated pain reduction before and after 
surgical abortion using a 10 point pain VAS. The study followed participants in three groups: 
those who received TEAS pre-operatively only, those who received TEAS post-operatively only, 
and those who received TEAS both pre- and post-operatively. The groups were followed 
alongside a control group. The mean scores of the pre-operative and combined intervention 
groups reported lower mean pain scores at 10 min compared with the control group (control 
group VAS, 3.0; pre- VAS, 1.19 ± 1.94; combined VAS, 2.14 ± 1.6). The mean VAS scores of 
all TEAS cohorts were lower than control values (VAS scores not reported) at 30 min and 45 
min postop (p<0.001) (Feng, 2016). 
 
Wang et al. also used TEAS in a complex study that evaluated 135 participants undergoing 
surgical abortion. Participants were assigned to nine different protocols (not randomized) with 
the goal of determining the best protocol. There was no control group and each group had 15 
participants. They found that 15 minutes of TEAS stimulation before the procedure, on two 
specific acupoints, in nulliparous women 25-30 years old, and on at least their second 
pregnancy showed the best analgesic effects (Wang 2018). 
 
The feasibility and acceptability of using the Gold protocol as an adjunct to pain management 
during suction aspiration has already been shown in a Society for Family Planning (SFP) funded 
project completed by our graduated fellow Chioma Ndubisi, MD, at Columbia University Irving 
Medical Center (CUIMC). Dr. Ndubisi’s project showed auricular acupuncture using PyonexTM 

needles, as an adjunct to paracervical block and ibuprofen (usual care), substantially lowered 
pain and anxiety scores, compared to pain and anxiety among women assigned to placebo with 
usual care or usual care alone during first-trimester vacuum aspiration. Measured on a 100 mm 
VAS, the acupuncture, placebo, and usual care alone groups reported median maximum pain 
scores of 39, 70, and 71mm respectively (Ndubisi, 2018). 
 
1.3 Design and methodology 
 
1.3.1 Research design and General Methodological Approach 
 
This will be a randomized, double-blinded, placebo-controlled, three-arm trial at a single 
abortion practice at CUIMC to evaluate efficacy of auricular acupressure and auricular 
acupuncture as an adjunct to ibuprofen and paracervical block for decreasing pain and anxiety 
in those undergoing a first trimester vacuum aspiration. The detailed protocol will follow the 
SPIRIT (Standard Protocol Items; Recommendations for Interventional Trials) 2013 guidelines 
(Chan, 2013). The CUIMC Institutional Review Board (IRB) will approve the study protocol and 
we will register our trial with ClinicalTrials.gov. 
 
Dr. Ndubisi’s fellowship research project evaluated auricular acupuncture compared to placebo 
with an inert adhesive and to usual care for pain management during first-trimester aspiration 
abortion; that project provides relevant experience and data to support the methods proposed 
here. With this project, we also hope to validate her findings. 
 
1.3.1.a: Site 
 
We will recruit participants from a single abortion practice at CUIMC in New York City, NY. 
CUIMC serves a largely Latinx population in the Washington Heights neighborhood of 
Manhattan that is English and Spanish speaking, both privately or publicly insured. Once a 
week, up to 20 patients are scheduled for first trimester vacuum aspiration procedures. From 
the previous acupuncture study in our division, we expect to recruit at least 5 participants 
weekly (Ndubisi, 2018). 
 
In addition to the acupuncture study, this site has successfully conducted a randomized 
controlled trial to evaluate music as an auxiliary pain reduction intervention (Guerrero, 2012). 
 
1.3.1.b: Clinical care: 
 
Abortion providers consist of obstetrics and gynecology residents, family planning fellows, and 
family planning attendings. Clinical staff also includes medical assistants and a secretary. All of 
the staff are Spanish/English bilingual. 
 
Usual care for women seeking first trimester vacuum aspiration abortion includes history, 
relevant physical examination, gestational age determination using ultrasound, blood typing, 
and abortion consent. All patients undergoing first trimester vacuum aspiration receive 
ibuprofen 800 mg orally and doxycycline 200 mg orally. If the gestational age is ≥ 10 weeks, 
patient may also receive misoprostol 600 mcg vaginally 1.5 hours prior to the procedure for 

surgical ripening. All patients receive a paracervical block with 20 ml 1% lidocaine at 12, 4, and 
8 o’clock or 12, 5, and 7 o’clock. 
 
All patients are offered immediate IUDs or implants or a birth control prescription on the day of 
their procedure. If a patient is Rh negative, she will receive RhoGAM on the procedure day. All 
patients receive written instructions that specify where to call for emergencies. 
 
1.3.1.c: Participants 
 
Most of the patients are Hispanic, live in the surrounding community, have incomes below 
100% of the federal poverty line, and receive NYS Medicaid which covers their abortion care. 
Patients with commercial insurance receive care at the same site. The study population will 
consist of women seeking first trimester vacuum aspiration, either for elective abortion or 
management of an abnormal pregnancy or early pregnancy loss. Further inclusion and exclusion 
criteria are listed below in section 1.3.2. Study forms will not include any personal identifiers 
and all participants will be assigned study identification numbers to protect confidentiality. 
Forty-seven participants per treatment group will be required for a total of 141 participants 
(see section 1.3.11 for further details on estimating out sample size). 
 
1.3.1.d: Intervention 
 
The family planning attending will review the appointment log to identify patients who may be 
eligible to participate and provide the names to the research assistant. Our IRB requires that 
the attending physician must refer patients to any study, and that research assistants cannot 
recruit before obtaining attending physician approval. In the registration area the research 
assistant will approach potential participants and will provide an information letter 
summarizing the study and stating the research objectives (See Appendix F). If a patient states 
interest in the study and meets inclusion criteria, the research assistant will proceed with the 
informed consent process; this will include signing the required HIPAA and Columbia 
University consent forms. After informed consent and while waiting for scheduled appointment, 
research assistants will collect demographic information and baseline characteristics into a 
preprogrammed electronic table from which all information will be transmitted directly into the 
study REDCap database. Demographic information and baseline characteristics will include 
variables that may affect pain from vacuum aspiration and response to auriculotherapy, to 
include gestational age, prior reproductive history, history of dysmenorrhea and prior 
acupuncture treatments (See Appendix G). 
 
The research assistant will collect baseline pain and anxiety scores using 100 mm VAS 
preprogrammed into a pre-programmed electronic tablet linked to the study REDCap database. 
A VAS-P (pain) with anchors at 0 mm = no pain and 100 mm = worst pain in my life will be 
used to collect pain scores. A VAS-A (anxiety) with anchors at 0 mm = not at all anxious and 
100 mm = worst anxiety of my life will be used to collect anxiety scores. The VAS is a validated 
pain scale measure often used to measure the intensity of pain and is also validated to measure 
anxiety (Facco, 2013; Renner, 2010). 
 
The medical assistant will call each participant into the exam room as scheduled and obtain her 

baseline vital signs. The abortion provider will then complete a history and physical, a sonogram 
if needed, and collect a blood sample for Rh status confirmation. If the participant is 
determined to be an appropriate candidate for a suction aspiration, she will then undergo the 
routine informed consent process for the vacuum aspiration. The abortion provider give the 
participant her prophylactic doxycycline 200 mg orally and ibuprofen 800 mg orally. 
Approximately 20% of our office population may receive 600 mcg of pre-operative vaginal 
misoprostol for cervical ripening 1.5 hours prior to the procedure (if gestational age ≥ 10 week). 
The abortion provider will then step out of the room and inform the research assistant that the 
patient will undergo a first trimester vacuum aspiration. 
 
The participants will then be randomized into one of the three arms of the study. The research 
assistant will give the next sequential opaque sealed envelope containing the treatment 
assignment to the auriculotherapy provider (see section 1.3.3 for additional details on 
randomization and assignment groups). All providers in our practice will be trained as part of 
another ongoing auriculotherapy study. The auriculotherapy provider will always be different 
from the research assistant and the abortion provider. 
 
The auriculotherapy provider will open the assignment envelope and enter the room without 
the research assistant or the abortion provider. Each auriculotherapy intervention will follow a 
script and participants will be told “that they may or may not feel a sensation from the 
treatment”. Both ears will be cleaned with alcohol and the acupressure beads, the PyonexTM 
needles, or the placebo adhesives will be placed following the Gold protocol (See Appendix B) 
within 10 minutes prior to procedure start. Those participants in the placebo arm will receive 
placement of similarly sized adhesives. After placement of the adhesives, the auriculotherapy 
provider will place a surgical cap on the participant’s head to cover both ears to maintain 
blinding of the abortion providers and research assistant. After covering the ears with the 
surgical cap, the auriculotherapy provider will leave the room. 
 
During the procedure, emotional support from the medical assistant in the room will be 
available to each woman as needed. An additional support person is allowed in the procedure 
room per patient request. 
 
At the start of the procedure, the abortion provider will place a speculum in the vagina and 
clean the cervix with chlorhexidine antiseptic solution. The provider will also perform a 
paracervical block with 20 ml 1% lidocaine at 12, 4, and 8 o’clock or 12, 5, and 7 o’clock. Based 
on the abortion provider’s clinical judgment, a manual or electronic vacuum aspiration will then 
take place in the usual fashion. 
 
1.3.1.e: Outcomes 
 
At the completion of the procedure (within 5 minutes of speculum removal) the patient will 
complete a VAS-P and a VAS-A to report her maximum pain and anxiety experienced during the 
procedure. Participants will then be asked to complete a satisfaction survey and to identify the 
treatment arm they believe they were in. All data collected will be entered into a 
preprogrammed electronic tablet directly linked to our study REDCap database. The 
auriculotherapy provider will then remove the participant’s surgical cap and the adhesives. The 

participant will receive thanks for participating in the study and $25 for compensation prior to 
being discharged home. 
 
1.3.2 Criteria for the selection of subjects 
 
Women presenting for first trimester suction aspiration, either for elective abortion or 
management of an abnormal pregnancy or early pregnancy loss, to our single abortion practice 
at CUMC will be invited to participate in the study. 
1.3.2.a: Inclusion Criteria 
􀂾 English or Spanish speaking women 
􀂾 Age 18 or older 
􀂾 Seeking suction aspiration for any first-trimester elective abortion, an abnormal 
pregnancy, early pregnancy loss, retained products of conception, or molar pregnancy 
􀂾 Intrauterine pregnancy with measured gestational age less than or equal to 13 weeks 
and 0 days 
􀂾 Willingness to receive auriculotherapy 
􀂾 Willingness to be randomized into one of the three arms 
1.3.2.b: Exclusion Criteria 
􀂾 Does not meet inclusion criteria 
􀂾 Allergy to adhesives or gold. 
􀂾 Allergy to or cannot receive ibuprofen or 1% lidocaine 
􀂾 Congenital anomaly or infection of the ear 
 
1.3.3 Subject recruitment and allocation 
 
Participant recruitment will occur at our abortion practice at CUIMC where we plan to enroll 5 
participants weekly at our weekly office session (see 1.3.1.a for further characteristics of our 
site). 
 
The participants will be randomized into one of the three interventions: 1 - usual care plus 
auricular acupressure with gold beads, 2 - usual care plus auricular acupuncture with PyonexTM 
needles, or 3-usual care plus placebo with similarly sized adhesives. Usual care consists of 
ibuprofen and paracervical block. 
 
Prior to onset of recruitment, research staff not involved in participant recruitment will 
determine the 1:1:1 allocation in blocks of 6 using a random number table and will prepare the 
sequentially numbered, sealed, opaque envelopes. 
 
The auriculotherapy provider will open the assignment envelope and enter the room without 
the research assistant or the abortion provider. The assignment will not be revealed to the 
participant, abortion provider, research assistant, or clinical staff. The auriculotherapy provider 
will place the needles bilaterally, out of the view of the participant, using the Gold protocol 
acupoints (See Appendix B). 
 
1.3.4 Description of the drugs and devices to be studied 
 

We will perform the Gold protocol (See Appendix B) with single-use 1.2mm 24k Gold-Plated 
Accu-Patch beads by Lhasa Oms Inc. on participants randomized to the usual care plus 
acupressure arm (See Appendix C). On participants randomized to the usual care plus auricular 
acupuncture arm, we will use single-use 1.2mm Pyonex™ needles named Seirin Pyonex™ 
Acupuncture Needles manufactured by Seirin-America, INC (See Appendix D). We plan to use 
Curad Sterile Adhesive Sensitive Skin Spot Bandages manufactured by Curad Store for our usual 
care plus placebo group that will be cut to 10mm in diameter (See Appendix E). 
 
1.3.5 Admission procedure 
 
In the registration area the research assistant will approach potential participants, (identified 
earlier by the attending), immediately after registration and will provide an information letter 
summarizing the study and stating the research objectives (See Appendix F). The research 
assistant will proceed with the informed consent process with interested patients who meet 
inclusion criteria. Participants will undergo the assessment and intervention as described in 
section 1.3.1.d. 
 
1.3.6 Follow‐up procedure 
 
All study activities occur during a participant’s single office visit. All assessments and forms will 
be completed prior to the participant’s departure after the abortion procedure. There will be 
no need for additional follow up. 
 
1.3.7 Criteria for discontinuation 
 
Participant may be discontinued from participation in the research at any point secondary to: 
􀂾 Suction aspiration not completed 
􀂾 Procedure not indicated for office setting due to comorbidities, complete spontaneous 
abortion, participant changes her mind about having an abortion, and gestational age > 
13 weeks and 0 days 
􀂾 Participant leaves prior to completion of post-procedure forms 
􀂾 Participant withdraws from the study 
Participants are enrolled before she is determined to be an appropriate candidate for a suction 
aspiration as to not interrupt the clinic flow. In Dr. Ndubisi’s study, after enrollment, 26 
participants were excluded (24 because they did not have a suction aspiration and two because 
acupuncturist was not available). Randomization, however, will occur after participant is 
determined to be an appropriate candidate for a suction aspiration. In Dr. Ndubisi’s study, only 
three participants (one from each arm) were excluded, one due to randomization error and two 
because they did not undergo a procedure (Ndubisi, 2018). 
 
1.3.8 Laboratory and other investigations 
 
NONE 
 
1.3.9 Data management 
 

The CUIMC Division of Family Planning and Preventive Services currently employs a research 
manager and three research assistants who will be available to assist with this study. The 
research manager will assist the investigators with IRB preparation and submission, staff 
training manuals, and data monitoring. In addition, three medical students are volunteering 
their time as research assistants for this study. 
 
All data will be entered into pre-programmed tablets directly linked to our study REDCap 
database. REDCap is IRB-approved for use at CUIMC and the research office is familiar with its 
use. We used this approach to data collection in the previous trial of acupuncture for aspiration 
abortion pain, and thus we will be able to adapt the existing programs and database for the 
proposed study. 
 
All staff members involved with data management will be required to complete CUIMC’s 
Research Compliance and Administration System (RASCAL) and HIPPA trainings. Only 
research team members will be permitted access to study data. All data will be managed on 
CUIMCencrypted computing devices which are password protected, fire-wall devices linked to a 
secure server located within the Department of Obstetrics and Gynecology. 
 
1.3.10 Data analysis 
 
1.3.10.a: Descriptive statistics 
 
We will also collect participants’ demographic and baseline characteristics using an enrollment 
questionnaire (See appendix F) that will include variables that may affect pain from vacuum 
aspiration and response to auriculotherapy. While randomization should result in balanced 
groups, we will also assess the adequacy of randomization between the treatment arms and 
include appropriate factors in adjusted analysis. 
Demographic characteristics 
􀂾 Age (in years) 
􀂾 Education (≤ high school; > high school) 
􀂾 Preferred language 
􀂾 Body mass index 
􀂾 Race/Ethnicity 
􀂾 Illicit drug use/alcohol abuse 
􀂾 Anxiety or depression medication use < 30 days 
􀂾 Past acupuncture use 
Reproductive history 
􀂾 Worst degree of dysmenorrhea in the previous year (none, mild, moderate, severe) 
􀂾 Parity, proximity to last birth 
􀂾 Prior number of suction aspirations 
􀂾 Gestational age 
􀂾 Elective abortion vs. early pregnancy loss or management or abnormal pregnancy 
􀂾 Mode of aspiration: manual or electric 
 
1.3.10.b: Primary analysis - Acupressure vs Placebo 
 

We will analyze the difference between the median (in the previous study the VAS scores were 
not normally distributed, therefore, we will compare medians not means) subject-reported 
maximum pain score; as measured by VAS-P among women randomized to receive usual care 
plus auricular acupressure vs usual care plus placebo. 
 
1.3.10.c: Secondary analysis - Acupuncture vs Placebo 
 
We will analyze the difference between the median subject-reported maximum pain score; as 
measured by VAS-P among women randomized to receive usual care plus auricular acupuncture 
with needles vs usual care plus placebo. This analysis will aid in validating the previous 
acupuncture study performed in our division. 
 
1.3.10.d: Exploratory analysis 
 
Anxiety: We will also analyze the difference between the median subject-reported maximum 
anxiety score; as measured by VAS-A between the three study arms. 
Satisfaction: A satisfaction survey will assess the participant global satisfaction (see Appendix 
H). 
Participant identification of treatment arm: At the end of their visit, participants will be asked to 
identify which treatment arm they received. 
 
1.3.10.e: Statistical Analysis 
 
This will be an intention-to-treat analysis to maintain comparability of our treatment arms 
following randomization. All analyses will initially be carried out blinded to the treatment 
assignment in order to reduce any bias in the analysis. Demographic and baseline 
characteristics among the three different groups will be compared with Chi-square tests for 
categorical variables and Analysis of variance (ANOVA) for continuous variables. Expecting 
that the VAS scores will not be normally distributed, we plan to use non-parametric tests 
(Kruskal- Wallis and Mann-Whitney tests) to compare VAS pain and anxiety scores between the 
groups. Analysis will be conducted using SPSS once sample size has been achieved. 
 
1.3.11 Number of subjects and statistical power 
 
Estimating an effect size of 20 mm with standard deviation of 30 (calculated from the prior 
acupuncture study), 80% power, a 5 % level of significance, and accounting for a 20% dropout, 
the study will require 47 participants in each arm for a total of 141 participants. 
An effect size of 20 mm was selected given prior studies that evaluated at non-pharmacologic 
pain management during first-trimester abortion (Tschann, 2018; Wang, 2018). Dr. Ndubisi’s 
acupuncture study observed a standard deviation of 30mm. A 20% dropout rate was noted 
among enrolled participants who were not eligible for a procedure, decided to not undergo a 
procedure, or had incomplete data (Personal Communication, Chioma Ndubisi, MD). 
 
1.3.12 Study limitations 
 
The proposed study will have several limitations. Since our office serves a predominately 

Dominican Hispanic community, our findings might only be generalizable to a similar 
population. 
 
The ear surface area of is small, therefore using placebo adhesives as a control may have a 
stimulatory, and thereby, a therapeutic effect. Such an effect would decrease the difference 
between groups. The pain scores in the placebo group in the previous study were similar to 
those reported in previous studies; therefore, such a placebo effect seems unlikely. 
 
Participant blinding is likely to be incomplete. From Dr. Ndubisi’s study, we know that about 2/3 
of the participants were able to correctly identify their treatment arm. It is possible that 
knowing the treatment arm may affect pain experienced. Auriculotherapy providers will follow 
a script to describe the intervention to participants which will include statements about the 
possibility of feeling or not feeling a sensation. The auriculotherapy provider will also place the 
treatment out of sight of the participant. Participants will also be asked to identify the 
treatment arm they were in at the end of their study visit to further evaluate this finding. 
 
1.3.13 Duration of project 
 
Refer to Appendix I for the description of the proposed time. 
 
1.4 Project management 
 
The primary faculty mentors for this study are Dr. Carolyn Westhoff and Dr. Melanie A. Gold. 
Fellowship Director Dr. Anne Davis will provide additional guidance. Dr. Johana D. Oviedo will 
be responsible preparation of study documents and protocols, training research coordinators 
on study protocols, analyzing data, presenting findings, and writing manuscript (See 3.2.A. 
Budget Justification. Personnel for further discussion of project roles). 
 
1.5 Links with other projects 
 
The proposed project is linked to a SFP- funded randomized trial that will evaluate 
auriculotherapy to reduce pain experienced during medication abortion. The medication 
abortion study will include the same three arms proposed in this study. All abortion providers 
and our nurse practitioner will be trained to be auriculotherapy providers for both projects. 
 
1.6 Main problems anticipated 
 
Based on Dr. Ndubisi’s study, we expect to recruit approximately 5 participants weekly. There is 
the possibility, however, that demand for these procedures will decrease. Between 2008 and 
2014, the overall U.S. abortion rate declined by 25% (Guttmacher, 2018). In addition, our clinic 
site changed to a different location in November, 2018. Thus far, we continue to serve the same 
population with the same clinical staff and the same number of weekly procedures. We 
anticipate approximately 8 months to complete recruitment, but we will be able to continue 
enrolling for a total of 12 months if needed. In addition, the previous study showed the 
acceptability and feasibility of an auriculotherapy study in this practice. We have experience 
with the logistics of carrying out a project of this nature at this site. In addition, given our link 

to the medical abortion auriculotherapy project (see 1.5), all abortion providers in our division 
and our nurse practitioner will be trained to be auriculotherapy providers for this study. This 
will improve efficiency in enrollment of study participants. 
 
The majority of our patient population is Latinx, particularly Dominican, and a large proportion 
of them are Spanish-speaking only. We understand that communication with our patients is 
essential to their care and their participation in our study. The office staff is bilingual and half of 
the abortion providers speak Spanish fluently. We have successfully identified bilingual research 
assistants for the study. In addition, our office is equipped to provide interpretation services 24 
hours a day 7 days a week. 
 
1.7 Expected outcomes of the study and dissemination of findings 
 
We anticipate that the addition of auriculotherapy (acupuncture and acupressure) will decrease 
pain and anxiety during abortion and improve patients’ experience with abortion. If we 
demonstrate a decrease in pain and anxiety with auriculotherapy, we can teach abortion 
providers how to integrate auriculotherapy into abortion care. Given the variety in state 
regulations with regards to acupuncture, acupressure may be a necessary alternative, if this 
approach is similarly effective. 
 
Several clinics at CUIMC already use acupuncture and acupressure for pain management, which 
further supports feasibility of providing this service to women seeking abortion. 
Our abortion practice is unable to provide moderate sedation due to burdensome and 
expensive regulatory requirements. Auricular acupressure could be a safe and cost-effective 
alternative to sedation and does not add additional regulatory requirements or costs. In 
addition, auricular acupressure may prove useful for pain management during laminaria and 
intrauterine device insertion. Auricular acupressure could increase access to abortion care by 
helping outpatient clinics bypass regulations and financial barriers of sedation. 
 
1.8 References 
 
Ai, X., Wang, L., Liu, X., Cai, C., Yi, W. (2018). Electroacupuncture of Hegu(LI 4) and 
Sanyinjiao(SP 
6) Assists Medicinal Abortion. Zhen Ci Yan Jiu. 43(7): 456-9. ABSTRACT ONLY. 
Bayer, L., Edelman, A., Fur, R., Lambert, W., Nichols, M., Beranek, P., Miller, K., Jensen, J. 
(2015). 
An evaluation of oral midazolam for anxiety and pain in first-trimester surgical abortion: A 
randomized controlled trial. Obstetrics & Gynecology. 126(1): 37-46 
Chan, A.W., J.M. Tezlaff, D.G. Altman, A. Laupacis, P.C. Gotzsche, K. Krleza-Jeric, A. 
Hrobjartsson, H. Mann, K. Dickersin, J.A. Berlin, C.J. Dore, W.R. Parulekar, W.S. Summerskill, 
T. 
Groves, K.F. Schulz, H.C. Sox, F.W. Rockhold, D. Rennie and D. Moher (2013). SPIRIT 2013 
statement: defining standard protocol items for clinical trials. Ann Intern Med. 158(3): 200-207 
Chen, C., Xie, W., Wang, Z., Zeng, L. Liu, P., Li, C. (2017). Optimal acupoint combination of 
transcutaneous electrical stimulation in artificial abortion operation. Zhongguo Zhen Jiu. 37(2): 
175-179. ABSTRACT ONLY. 

Cheng, X., Wang, Z., Lin, Q., Chen, M. (2010). Effect of transcutaneous electrical acupoint 
stimulation on BIS and VAS in artificial abortion operation. Zhongguo Zhen Jiu. 30(4): 305-7. 
ABSTRACT ONLY. 
Feng, X., Tianshen, Y., et al (2016). Transcutaneous acupoint electrical stimulation pain 
management after surgical abortion: A cohort study. International Journal of Surgery. 30(2016) 
104-108. 
Facco E., Stellini E., Bacci C., Manani G., Pavan C., Cavallin F., Zanette G. (2013). Validation 
of 
visual analogue scale for anxiety (VAS-A) in preanesthesia evaluation. Minerva Anestesiologica. 
2013; 79:1389-95. 
Guerrero, J.M., P.M. Castano, E.O. Schmidt, L. Rosario and C.L. Westhoff (2012). Music as an 
auxiliary analgesic during first trimester surgical abortion: a randomized trial. Contraception. 
86(2): 157-162 
Guttmacher Institute (2018). Induced abortion in the United States. Fact Sheet. Available at 
https://www.guttmacher.org/fact-sheet/induced-abortion-united-states 
Jatlaoui, T., Shah, J., Mandel, M., Krashin, J., Suchdev, D., Jamieson, D., Pazol, K. (2017). 
Abortion Surveillance – United States, 2014. Morbidity and Mortality Weekly Report. CDC. 
66(24): 1–48 
Jatlaoui, T., Boutot, M., Mandel, M., Whiteman, M., Ti, A., Petersen, E., Pazol, K. (2018). 
Abortion Surveillance – United States, 2015. Morbidity and Mortality Weekly Report. CDC. 
67(13): 1-45. 
Leggit J (2014). Introduction to Integrative Health and Acupuncture to Pre Clerkship Medical 
Students. Medical Acupuncture. 26(4): 226-229. 
Lin, M. & Tung, C (2017). The regulation of the practice of acupuncture by physicians in the 
United States. Medical Acupuncture. 29(3):121-127 
Micks, E., Edelman, A., Renner, R., Fu, R., Lambert, W., Bednarek, P., Nichols, M., Beckley, 
E., 
Jensen, J. (2012). Hydrocodone-Acetaminophen for pain control in first-trimester surgical 
abortion: A randomized controlled trial. Obstetrics & Gynecology. 120(5): 1060-1069 
Moayedi, G., Tschann, M. (2018). Pain management for first-trimester uterine aspiration. 
Obstetrical and Gynecological Survey. 73(3): 174-181 
National Academies of Sciences, Engineering, and Medicine. (2018). The safety and quality of 
abortion care in the United States. Washington, DC: The National Academies Press. doi: 
https://doi.org/10.17226/24950 
Ndubisi, C., Danvers, A., Gold, M., Morrow, L., Westhoff, C. (2018). Auricular acupuncture as 
an 
adjunct for pain management during first trimester abortion: a randomized, double-blinded, 
three-arm trial. Contraception. Accepted for publication. 
Niemtzow, R. (2018) Battlefield acupuncture: My story [Editorial]. Medical Acupuncture. 30(2): 
57-58 
O’Connell, K., Jones, H., Simon, M., Saporta, V., Paul, M., Lichtenberg, E. (2009). First-
trimester 
surgical abortion practices: a survey of National Abortion Federation members. Contraception. 
79(5):385-392 
Oleson, T. (2014). Auriculotherapy manual: Chinese and western systems of ear acupuncture. 
(4th ed.). Niemtzow, R. (foreword). Churchill Livingstone Elsevier 

Platon, B., Andrell, P., et al. (2010). High frequency, high intensity transcutaneous electrical 
nerve stimulation as treatment of pain after surgical abortion. Pain. 148(2010): 114-119. 
Renner R.M., Jensen, JT., et al. (2010). Pain control in first-trimester surgical abortion: a 
systematic review of randomized controlled trials. Contraception. 81(5): 372-388. 
Serfaty, D., Buttiqieq, C., Dreyfus, R. (1979). Induced abortion under acupunctural analgesia (25 
cases). Contracept Fertil Sex (Paris). 7(8):557-62. ABSTRACT ONLY. 
Smith, C.A., Collins, C.T., Crowther, C.A., Levett, K.M. (2011). Acupuncture or acupressure for 
pain management in labour. Cochrane Database of Systematic Reviews. First published: 6 July 
2011 
Tsai, S., Fox, L., et al. (2016). Auricular Acupuncture in Emergency Department Treatment of 
Acute Pain. Annals of Emergency Medicine. 68(5) 583-585 
Tshann, M., Salcedo, J., Soon R., Kaneshiro B. (2018). Patient choice of adjunctive 
nonpharmacologic pain management during first-trimester abortion: a randomized controlled 
trial. Contraception. 98(3): 205-209 
Wang, Z., Chen, Y., Chen, C., Zhao, L., Chen, P., Zeng, L., Xie, W. (2018). Pain management of 
surgical abortion using transcutaneous acupoint electrical stimulation: An orthogonal 
prospective study. The Journal of Obstetrics and Gynecology Research. 44(7): 1235-1242 
White, K., Jones, H., Lavalenet, A., Norman, W., Guilbert, E., Lichtenberg E., Paul, M. (2018). 
First-trimester aspiration abortion practices: a survey of United States abortion providers. 
Contraception. doi: https://doi.org/10.1016/j.contraception.2018.08.011 
Ying, Y., Lin, J., Robins, J. (1985). Acupuncture for the induction of cervical dilatation in 
preparation for first-trimester abortion and its influence on HCG. J Reprod Med. 30(7):530-4. 
ABSTRACT ONLY 
You, E., Kim, D., Harris, R., D’Alonzo, K. (2018). Effects of auricular acupressure of pain 
management: A systematic review. Pain Management Nursing. Doi: 
https://doi.org/10.1016/j.pmn.2018.07.010 
 
2. ETHICAL CONSIDERATIONS 
 
2.1 Informed decision‐making and confidentiality 
 
We will invite women to participate in this study only after they have already made and kept 
their appointment for an aspiration abortion; thus, the study will have no influence on whether 
women might seek abortion care. 
 
We will obtain approval for this research protocol, informed consent, and all the associated 
forms from the Institutional Review Board (IRB) at Columbia University prior to initiation of the 
study. Modifications to the protocol that may affect the conduct of the study will need 
approval from the IRB prior to implementing changes. 
 
All participant information will be confidential in accordance with Health Insurance Portability 
and Accountability Act (HIPAA) guidelines. All participants will have a study identification 
number to protect patient confidentiality. Study forms and data collection tools will be 
entered into pre-programmed tablets directly linked to our study REDCap database. REDCap is 
IRB approved for use at CUIMC. 
 

All participants will receive copies of consent forms following the informed consent process. 
For Spanish speaking participants, all necessary forms and questionnaires will be translated 
into Spanish and accuracy of translated materials verified and approved by CUIMC Translation 
Center, in accordance with IRB requirements. Participants are able to withdraw from the study 
at any point.