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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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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 Pyonexâ„¢ 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 Pyonexâ„¢ needles reduces subject-reported anxiety scores during first trimester vacuum aspiration as compared to women receiving usual care plus placebo.
Most first trimester aspiration abortions are performed in the outpatient setting with a paracervical block and nonsteroidal anti-inflammatory drugs (NSAIDs) as the only analgesics. Yet first trimester aspiration pain control is often inadequate with 26-32% of women reporting that they experienced severe pain. Moderate sedation and general anesthesia are not readily available, and investigations on opioids and anxiolytics have consistently found them ineffective for first trimester aspiration abortion pain. In 2018, The National Academies of Sciences, Engineering, and Medicine (NASEM) recommended research to improve pain relief. Limited data indicate that acupuncture is valuable in dysmenorrhea and for labor pain, conditions in which pain may be similar to that experienced during aspiration abortion.
This randomized trial will recruit women seeking first trimester aspiration abortion. This study will evaluate two types of auriculotherapy applied to selected acupoints on the external ear. The study treatments are acupressure using gold beads and acupuncture using Pyonex needles; both are applied to the ear using adhesive disks. A control group will receive the adhesive disks alone. All participants will receive usual care for their aspiration abortion procedure, including a paracervical block and ibuprofen for pain management. The investigators will query the participants regarding pain and anxiety immediately after their procedure, in person, on the day of their procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auriculotherapy - Acupressure with Gold Beads | Active Comparator | 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. |
|
| Auriculotherapy - Acupuncture with Pyonex Needles | Active Comparator | 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. |
|
| Placebo Group | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupressure with Beads | Device | Single-use gold-plated 1.2mm beads/balls attach to pre-specified acupoints on the participant's ears with adhesive disk/tape. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Visual Analog Scale Score (Beads vs Placebo) | Self-assessed maximum pain reported using a 0-100mm visual analog scale, where 100 signifies maximum pain. To measure pain experienced during aspiration abortion. | Immediately following the aspiration abortion procedure (approximately 10 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Visual Analog Scale Score (Needles vs Placebo) | Self-assessed maximum pain reported using a 0-100mm visual analog scale, where 100 signifies maximum pain. To measure pain experienced during aspiration abortion. | Immediately following the aspiration abortion procedure (approximately 10 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety Visual Analog Scale Score | Self-assessed maximum anxiety reported using a 0-100 mm visual analog scale, where 100 signifies maximum anxiety. To measure anxiety during aspiration abortion. | Immediately following the aspiration abortion procedure (approximately 10 minutes) |
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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 |
|---|---|---|---|
| 30529393 | Background | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. Acupuncture with Needles: Single-use 1.2mm acupuncture press needles attach to pre-specified acupoints on the participant's ears with adhesive disk/tape. |
| FG002 | 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. Placebo Adhesive Disks: Single-use adhesive disks without needles or beads. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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 | Pain Visual Analog Scale Score (Beads vs Placebo) | Self-assessed maximum pain reported using a 0-100mm visual analog scale, where 100 signifies maximum pain. To measure pain experienced during aspiration abortion. | Posted | Median | Inter-Quartile Range | score on a scale | Immediately following the aspiration abortion procedure (approximately 10 minutes) |
|
During and immediately following the aspiration abortion procedure (approximately 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 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carolyn Westhoff, MD | Columbia University | 212-305-4805 | clw3@cumc.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 | Dec 5, 2018 | Dec 11, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D019050 | Acupressure |
| D015670 | Acupuncture Therapy |
| D009339 | Needles |
| ID | Term |
|---|---|
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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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).
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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.
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| Acupuncture with Needles | Device | Single-use 1.2mm acupuncture press needles attach to pre-specified acupoints on the participant's ears with adhesive disk/tape. |
|
|
| Placebo Adhesive Disks | Device | Single-use adhesive disks without needles or beads. |
|
|
| BG001 | 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. Acupuncture with Needles: Single-use 1.2mm acupuncture press needles attach to pre-specified acupoints on the participant's ears with adhesive disk/tape. |
| BG002 | 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. Placebo Adhesive Disks: Single-use adhesive disks without needles or beads. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 |
| 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. Placebo Adhesive Disks: Single-use adhesive disks without needles or beads. |
|
|
| Secondary | Pain Visual Analog Scale Score (Needles vs Placebo) | Self-assessed maximum pain reported using a 0-100mm visual analog scale, where 100 signifies maximum pain. To measure pain experienced during aspiration abortion. | Posted | Median | Inter-Quartile Range | score on a scale | Immediately following the aspiration abortion procedure (approximately 10 minutes) |
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| Other Pre-specified | Anxiety Visual Analog Scale Score | Self-assessed maximum anxiety reported using a 0-100 mm visual analog scale, where 100 signifies maximum anxiety. To measure anxiety during aspiration abortion. | Posted | Median | Inter-Quartile Range | score on a scale | Immediately following the aspiration abortion procedure (approximately 10 minutes) |
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|
| 0 |
| 70 |
| 0 |
| 70 |
| 0 |
| 70 |
| EG001 | 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. Acupuncture with Needles: Single-use 1.2mm acupuncture press needles attach to pre-specified acupoints on the participant's ears with adhesive disk/tape. | 0 | 51 | 0 | 51 | 0 | 51 |
| EG002 | 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. Placebo Adhesive Disks: Single-use adhesive disks without needles or beads. | 0 | 52 | 0 | 52 | 0 | 52 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004864 | Equipment and Supplies |