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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pyonex needles | Active Comparator | This arm will receive modified battlefield auricular acupuncture using SEIRIN® Pyonex™ Acupuncture Needles. |
|
| Placebo adhesives | Placebo Comparator | This arm will receive placement of adhesives using the modified battlefield auricular acupuncture placement points using 12 mm Plasters. |
|
| Routine Care | No Intervention | This arm will receive no intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SEIRIN® Pyonex™ Acupuncture Needles | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale for Pain (VAS Pain) Score - Acupuncture Versus Routine Care | Measure effectiveness of auricular acupuncture as an adjunct to ibuprofen and paracervical block for pain control during first trimester uterine aspiration by comparing the maximum pain score; as measured by VAS between women randomized to receive auricular acupuncture and routine care controls - using a 100 mm visual analog scale (VAS-P) (anchors: 0 mm = no pain, 100 mm = worst pain in my life). The VAS has no sub-scales. | at the completion of the procedure (approximately 10 minutes later) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Analog Scale for Pain (VAS Pain) Score - Placebo Versus Routine Care | Measure effectiveness of placebo as an adjunct to ibuprofen and paracervical block for pain control during uterine aspiration by comparing the maximum pain score; as measured by VAS between women randomized to receive placebo adhesives and routine care controls - using a 100 mm visual analog scale (VAS-P) (anchors: 0 mm = no pain, 100 mm = worst pain in my life). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carolyn Westhoff, MD MSc | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19155895 | Background | Allen RH, Fitzmaurice G, Lifford KL, Lasic M, Goldberg AB. Oral compared with intravenous sedation for first-trimester surgical abortion: a randomized controlled trial. Obstet Gynecol. 2009 Feb;113(2 Pt 1):276-83. doi: 10.1097/AOG.0b013e3181938758. | |
| 17046383 | Background | Allen RH, Kumar D, Fitzmaurice G, Lifford KL, Goldberg AB. Pain management of first-trimester surgical abortion: effects of selection of local anesthesia with and without lorazepam or intravenous sedation. Contraception. 2006 Nov;74(5):407-13. doi: 10.1016/j.contraception.2006.06.002. Epub 2006 Aug 2. |
| Label | URL |
|---|---|
| Guttmacher Institute. 2016. Induced Abortion in the United States | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pyonex Needles | This arm will receive modified battlefield auricular acupuncture using SEIRIN® Pyonex™ Acupuncture Needles. 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 |
| FG001 | Placebo Adhesives | This arm will receive placement of adhesives using the modified battlefield auricular acupuncture placement points using 12 mm Plasters. 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 |
| FG002 | Routine Care | This arm will receive no intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pyonex Needles | This arm will receive modified battlefield auricular acupuncture using SEIRIN® Pyonex™ Acupuncture Needles. 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analog Scale for Pain (VAS Pain) Score - Acupuncture Versus Routine Care | Measure effectiveness of auricular acupuncture as an adjunct to ibuprofen and paracervical block for pain control during first trimester uterine aspiration by comparing the maximum pain score; as measured by VAS between women randomized to receive auricular acupuncture and routine care controls - using a 100 mm visual analog scale (VAS-P) (anchors: 0 mm = no pain, 100 mm = worst pain in my life). The VAS has no sub-scales. | The final analysis included 150 (out of 153) participants: 52 in the auricular acupuncture group, 49 in the placebo group and 49 in the routine (usual) care group. | Posted | Mean | Inter-Quartile Range | score on a scale | at the completion of the procedure (approximately 10 minutes later) |
|
The duration of the procedure (approximately 5-10 minutes)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pyonex Needles | This arm will receive modified battlefield auricular acupuncture using SEIRIN® Pyonex™ Acupuncture Needles. 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 |
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carolyn Westhoff, MD | Columbia University | 212-305-4805 | clw3@columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 17, 2018 | Apr 5, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009339 | Needles |
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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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.
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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.
|
| 12 mm Plasters | 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 |
|
|
| prior to the procedure (baseline), at the completion of the procedure (approximately 10 minutes later) |
| Percentage of Patients Rated Good or Very Good on Satisfaction Survey in Overall Care - Acupuncture Versus Routine Care | Using a satisfaction survey (investigator-developed, 6 questions, each question is graded on a scale of 1-5, 1 being very poor and 5 being very good) to measure effectiveness of auricular acupuncture for improving satisfaction. | at the completion of the procedure (approximately 5-10 minutes) |
| 24286993 | Background | Allen RH, Micks E, Edelman A. Pain relief for obstetric and gynecologic ambulatory procedures. Obstet Gynecol Clin North Am. 2013 Dec;40(4):625-45. doi: 10.1016/j.ogc.2013.08.005. |
| 25254059 | Background | Bae H, Bae H, Min BI, Cho S. Efficacy of acupuncture in reducing preoperative anxiety: a meta-analysis. Evid Based Complement Alternat Med. 2014;2014:850367. doi: 10.1155/2014/850367. Epub 2014 Sep 2. |
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| 9874014 | Background | Jensen MP, Miller L, Fisher LD. Assessment of pain during medical procedures: a comparison of three scales. Clin J Pain. 1998 Dec;14(4):343-9. doi: 10.1097/00002508-199812000-00012. |
| 14622683 | Background | Jensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. J Pain. 2003 Sep;4(7):407-14. doi: 10.1016/s1526-5900(03)00716-8. |
| 24494995 | Background | Jones RK, Jerman J. Abortion incidence and service availability in the United States, 2011. Perspect Sex Reprod Health. 2014 Mar;46(1):3-14. doi: 10.1363/46e0414. Epub 2014 Feb 3. |
| 19120322 | Background | Kindberg S, Klunder L, Strom J, Henriksen TB. Ear acupuncture or local anaesthetics as pain relief during postpartum surgical repair: a randomised controlled trial. BJOG. 2009 Mar;116(4):569-76. doi: 10.1111/j.1471-0528.2008.02016.x. Epub 2008 Dec 19. |
| 23522721 | Background | Kiran G, Gumusalan Y, Ekerbicer HC, Kiran H, Coskun A, Arikan DC. A randomized pilot study of acupuncture treatment for primary dysmenorrhea. Eur J Obstet Gynecol Reprod Biol. 2013 Jul;169(2):292-5. doi: 10.1016/j.ejogrb.2013.02.016. Epub 2013 Mar 20. |
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| 25184015 | Background | Leggit JC. Introduction of Integrative Health and Acupuncture to Pre-Clerkship Medical Students. Med Acupunct. 2014 Aug 1;26(4):226-229. doi: 10.1089/acu.2014.1045. |
| 23090523 | Background | Micks EA, Edelman AB, Renner RM, Fu R, Lambert WE, Bednarek PH, Nichols MD, Beckley EH, Jensen JT. Hydrocodone-acetaminophen for pain control in first-trimester surgical abortion: a randomized controlled trial. Obstet Gynecol. 2012 Nov;120(5):1060-9. doi: 10.1097/aog.0b013e31826c32f0. |
| 22219023 | Background | Michalek-Sauberer A, Gusenleitner E, Gleiss A, Tepper G, Deusch E. Auricular acupuncture effectively reduces state anxiety before dental treatment--a randomised controlled trial. Clin Oral Investig. 2012 Dec;16(6):1517-22. doi: 10.1007/s00784-011-0662-4. Epub 2012 Jan 6. |
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| Background | Oleson, T (1998). "Auriculotherapy Manual: Chinese and Western Systems of Ear Acupuncture, 2nd edition." California, Health Care Alternatives, Inc |
| 25426741 | Background | Pazol K, Creanga AA, Burley KD, Jamieson DJ. Abortion surveillance - United States, 2011. MMWR Surveill Summ. 2014 Nov 28;63(11):1-41. |
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| Background | White K, Jones H, Lichtenberg S, Paul M (2015). "First trimester surgical abortion practices in the United States." Poster presented at: Society of Family Planning Forum in 2015. |
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| 30529393 | Result | 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. |
| BG001 |
| Placebo Adhesives |
This arm will receive placement of adhesives using the modified battlefield auricular acupuncture placement points using 12 mm Plasters. 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 |
| BG002 | Routine Care | This arm will receive no intervention. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pregnancy type | Count of Participants | Participants |
|
| OG001 | Routine Care | This arm will receive no intervention. |
|
|
| Secondary | Change in Visual Analog Scale for Pain (VAS Pain) Score - Placebo Versus Routine Care | Measure effectiveness of placebo as an adjunct to ibuprofen and paracervical block for pain control during uterine aspiration by comparing the maximum pain score; as measured by VAS between women randomized to receive placebo adhesives and routine care controls - using a 100 mm visual analog scale (VAS-P) (anchors: 0 mm = no pain, 100 mm = worst pain in my life). | The final analysis included 150 (out of 153) participants: 52 in the auricular acupuncture group, 49 in the placebo group and 49 in the routine (usual) care group. | Posted | Mean | Inter-Quartile Range | score on a scale | prior to the procedure (baseline), at the completion of the procedure (approximately 10 minutes later) |
|
|
|
| Secondary | Percentage of Patients Rated Good or Very Good on Satisfaction Survey in Overall Care - Acupuncture Versus Routine Care | Using a satisfaction survey (investigator-developed, 6 questions, each question is graded on a scale of 1-5, 1 being very poor and 5 being very good) to measure effectiveness of auricular acupuncture for improving satisfaction. | The final analysis included 150 (out of 153) participants: 52 in the auricular acupuncture group, 49 in the placebo group and 49 in the routine (usual) care group. | Posted | Number | percentage of participants | at the completion of the procedure (approximately 5-10 minutes) |
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | Placebo Adhesives | This arm will receive placement of adhesives using the modified battlefield auricular acupuncture placement points using 12 mm Plasters. 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 | 0 | 49 | 0 | 49 | 0 | 49 |
| EG002 | Routine Care | This arm will receive no intervention. | 0 | 49 | 0 | 49 | 0 | 49 |
Not provided
Not provided
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