Acupuncture for Pain Management During Uterine Aspiration
NCT ID: NCT03391986
Last Updated: 2019-09-03
Study Results
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
153 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-09-09
Study Completion Date
2018-07-01
Brief Summary
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The proposed study will be a randomized, double blinded, placebo-controlled trial to evaluate the efficacy of auricular acupuncture as adjunct for pain management during abortion. Women seeking first trimester uterine aspiration procedure who enroll in the study will be randomized to receive: 1) auricular acupuncture using pyonex needles, 2) placebo using an adhesive, 3) or routine care. Both participants and the treating physician will be unaware of treatment assignment. The primary outcome will compare the maximum pain score as measured by the visual analog scale (VAS) between the auricular acupuncture group and the routine care group. The secondary outcome will compare the maximum pain score between placebo group to the routine care group. The study will also investigate patient satisfaction.
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Detailed Description
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Of the estimated 1.06 million abortions performed in the United States in 2011, approximately 91% occurred before 13 weeks gestation. Most first trimester abortions are performed in an outpatient center with a paracervical block as the only analgesic. Paracervical block is associated with improved pain control during dilation and aspiration however, women still experience moderate to severe pain. Moderate sedation and general anesthesia, minimize pain more than a paracervical block; however increased cost, regulatory constraints, side effects, health risks, and recovery time may limit abortion access.
Pain experienced during abortion results from a complex interaction of physical innervation pathways, psychological and social factors. Pain during abortion is also influenced by additional factors such as age, pregnancy history, and self-reported pre-procedure anxiety about abortion. Adequate pain management during suction aspiration might require interventions that influence mental and emotional states as well as physical pain.
Acupuncture affects perception of painful stimuli and improves anxiety. Peripheral stimulation of acupoints mobilizes central neuropeptides involved in the pathway of anxiety and stress. In auricular acupuncture, a technique of acupuncture, needles are placed in designated acupoints on the external ear in order to alleviate health conditions, in particular pain, in other parts of the body.
In a pilot study completed at Columbia University Medical Center (CUMC) in 2016, patients seeking first trimester uterine aspiration were interested in the complementary medicine technique of auricular acupuncture as an adjunct to local anesthesia. Currently, the effectiveness of auricular acupuncture to control pain during a uterine suction aspiration is unknown.
Participants will be randomized to either auricular acupuncture with pyonex needle adhesives, placebo adhesive, or routine care using a 1:1:1 ratio. The randomization scheme will use randomly permuted blocks with a block size of 4 or 6. An investigator experienced with generating randomization sequences and not directly involved in the study will be responsible for creating the entire randomized schedule; first by defining the sequence of block sizes and second, by defining the assignments within each block. The division research office at CUMC will prepare opaque, sealed envelopes containing cards indicating whether a given patient has been randomized to receive either pyonex needles, placebo adhesive, or routine care. The allocation will remain concealed from the patient and abortion provider. The acupuncturist will open the sealed, opaque envelope immediately prior to the suction aspiration procedure and perform the intervention according to randomization assignment.
Pain experienced during abortion results from a complex interaction of physical innervation pathways, psychological and social factors. Pain during abortion is also influenced by additional factors such as age, pregnancy history, and self-reported pre-procedure anxiety about abortion. Adequate pain management during suction aspiration might require interventions that influence mental and emotional states as well as physical pain.
Acupuncture affects perception of painful stimuli and improves anxiety. Peripheral stimulation of acupoints mobilizes central neuropeptides involved in the pathway of anxiety and stress. In auricular acupuncture, a technique of acupuncture, needles are placed in designated acupoints on the external ear in order to alleviate health conditions, in particular pain, in other parts of the body.
In a pilot study completed at Columbia University Medical Center (CUMC) in 2016, patients seeking first trimester uterine aspiration were interested in the complementary medicine technique of auricular acupuncture as an adjunct to local anesthesia. Currently, the effectiveness of auricular acupuncture to control pain during a uterine suction aspiration is unknown.
Participants will be randomized to either auricular acupuncture with pyonex needle adhesives, placebo adhesive, or routine care using a 1:1:1 ratio. The randomization scheme will use randomly permuted blocks with a block size of 4 or 6. An investigator experienced with generating randomization sequences and not directly involved in the study will be responsible for creating the entire randomized schedule; first by defining the sequence of block sizes and second, by defining the assignments within each block. The division research office at CUMC will prepare opaque, sealed envelopes containing cards indicating whether a given patient has been randomized to receive either pyonex needles, placebo adhesive, or routine care. The allocation will remain concealed from the patient and abortion provider. The acupuncturist will open the sealed, opaque envelope immediately prior to the suction aspiration procedure and perform the intervention according to randomization assignment.
Conditions
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Pain Acute
Acupuncture
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Participants will be randomized to either 1 - auricular acupuncture with pyonex needle, 2 - placebo adhesive, or 3 - routine care using a 1:1:1 ratio. The randomization scheme will use randomly permuted blocks with a block size of 6 or 9.
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
TRIPLE
Participants
Caregivers
Outcome Assessors
Participant: only participants in the pyonex needle and placebo adhesive group will be masked during the study. Equipment is opened behind the participant and the needles and adhesives are placed outside the view of the participant.
Care Provider: A colored hat that covers the participants ears will be placed. Outcomes Assessor: Group assignment will be masked.
Care Provider: A colored hat that covers the participants ears will be placed. Outcomes Assessor: Group assignment will be masked.
Study Groups
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Pyonex needles
This arm will receive modified battlefield auricular acupuncture using SEIRIN® Pyonex™ Acupuncture Needles.
Group Type
ACTIVE_COMPARATOR
SEIRIN® Pyonex™ Acupuncture Needles
Intervention Type
DEVICE
Needles will be placed on the right and left ear. Right ear - cingulate gyrus, thalamus, Point Zero, Shen Men, uterus. Left ear - cingulate gyrus, thalamus, Point Zero, Shen Men, cervix
Placebo adhesives
This arm will receive placement of adhesives using the modified battlefield auricular acupuncture placement points using 12 mm Plasters.
Group Type
PLACEBO_COMPARATOR
12 mm Plasters
Intervention Type
PROCEDURE
12 mm (0.5"). Latex-free Adhesives will be placed on the right and left ear. Right ear - cingulate gyrus, thalamus, Point Zero, Shen Men, uterus. Left ear - cingulate gyrus, thalamus, Point Zero, Shen Men, cervix
Routine Care
This arm will receive no intervention.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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SEIRIN® Pyonex™ Acupuncture Needles
Needles will be placed on the right and left ear. Right ear - cingulate gyrus, thalamus, Point Zero, Shen Men, uterus. Left ear - cingulate gyrus, thalamus, Point Zero, Shen Men, cervix
Intervention Type
DEVICE
12 mm Plasters
12 mm (0.5"). Latex-free Adhesives will be placed on the right and left ear. Right ear - cingulate gyrus, thalamus, Point Zero, Shen Men, uterus. Left ear - cingulate gyrus, thalamus, Point Zero, Shen Men, cervix
Intervention Type
PROCEDURE
Other Intervention Names
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Needle, Acupuncture, Single Use
hypoallergenic, adhesive replacement plasters
Eligibility Criteria
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Inclusion Criteria
* English- or Spanish-speaking women
* Age 18 or older
* Seeking first trimester suction aspiration for undesired pregnancy, early pregnancy failure, retained products of conception, or molar pregnancy
* Intrauterine pregnancy with gestational age less than or equal to 12 weeks and 6 days
* Willingness to receive acupuncture and be randomized in the study
* Age 18 or older
* Seeking first trimester suction aspiration for undesired pregnancy, early pregnancy failure, retained products of conception, or molar pregnancy
* Intrauterine pregnancy with gestational age less than or equal to 12 weeks and 6 days
* Willingness to receive acupuncture and be randomized in the study
Exclusion Criteria
* Allergy to adhesives
* Allergy to or cannot receive ibuprofen or 1% lidocaine
* Congenital anomalies of the ear including anotia and microtia
* Allergy to or cannot receive ibuprofen or 1% lidocaine
* Congenital anomalies of the ear including anotia and microtia
Minimum Eligible Age
18 Years
Maximum Eligible Age
55 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
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Society of Family Planning
OTHER
Sponsor Role
collaborator
Columbia University
OTHER
Sponsor Role
lead
Responsible Party
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Carolyn Westhoff
Professor of Epidemiology and Population and Family Health
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Carolyn Westhoff, MD MSc
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Columbia University Medical Center
New York, New York, United States
Site Status
Countries
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United States
References
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Wang SM, Dezinno P, Lin EC, Lin H, Yue JJ, Berman MR, Braveman F, Kain ZN. Auricular acupuncture as a treatment for pregnant women who have low back and posterior pelvic pain: a pilot study. Am J Obstet Gynecol. 2009 Sep;201(3):271.e1-9. doi: 10.1016/j.ajog.2009.04.028. Epub 2009 Jun 26.
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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.
Reference Type
RESULT
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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http://www.guttmacher.org/fact-sheet/induced-abortion-united-states
Guttmacher Institute. 2016. Induced Abortion in the United States
Other Identifiers
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AAAR2610
Identifier Type: -
Identifier Source: org_study_id
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