Abortion in First Trimester
Conditions
Keywords
auriculotherapy, abortion, pain management
Brief summary
Primary Objective: To assess whether usual care plus auricular acupressure with beads reduces subject-reported maximum pain during first trimester vacuum aspiration compared to usual care plus placebo. Secondary Objective: To assess whether usual care plus auricular acupuncture with Pyonex™ needles reduces subject-reported maximum pain during first trimester vacuum aspiration as compared to usual care plus placebo. This assessment will replicate the previous trial and strengthen the evidence that auricular acupuncture is beneficial for aspiration abortion pain Exploratory Objective: To assess whether usual care plus either auricular acupressure with beads or auricular acupuncture with Pyonex™ needles reduces subject-reported anxiety scores during first trimester vacuum aspiration as compared to women receiving usual care plus placebo.
Detailed description
Most first trimester aspiration abortions are performed in the outpatient setting with a paracervical block and nonsteroidal anti-inflammatory drugs (NSAIDs) as the only analgesics. Yet first trimester aspiration pain control is often inadequate with 26-32% of women reporting that they experienced severe pain. Moderate sedation and general anesthesia are not readily available, and investigations on opioids and anxiolytics have consistently found them ineffective for first trimester aspiration abortion pain. In 2018, The National Academies of Sciences, Engineering, and Medicine (NASEM) recommended research to improve pain relief. Limited data indicate that acupuncture is valuable in dysmenorrhea and for labor pain, conditions in which pain may be similar to that experienced during aspiration abortion. This randomized trial will recruit women seeking first trimester aspiration abortion. This study will evaluate two types of auriculotherapy applied to selected acupoints on the external ear. The study treatments are acupressure using gold beads and acupuncture using Pyonex needles; both are applied to the ear using adhesive disks. A control group will receive the adhesive disks alone. All participants will receive usual care for their aspiration abortion procedure, including a paracervical block and ibuprofen for pain management. The investigators will query the participants regarding pain and anxiety immediately after their procedure, in person, on the day of their procedure.
Interventions
DEVICEAcupressure with Beads
Single-use gold-plated 1.2mm beads/balls attach to pre-specified acupoints on the participant's ears with adhesive disk/tape.
DEVICEAcupuncture with Needles
Single-use 1.2mm acupuncture press needles attach to pre-specified acupoints on the participant's ears with adhesive disk/tape.
DEVICEPlacebo Adhesive Disks
Single-use adhesive disks without needles or beads.
Sponsors
Society of Family Planning
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
A designated investigator (auriculotherapy provider) will apply the intervention prior to the aspiration abortion; thus the care provider (abortion provider) will not be aware of the treatment arm. Participant will wear a surgical hat that covers their ears and the adhesive disks appear similar for the treatments and the placebo arm; thus the participants will be unaware of their treatment assignment. The research assistant collecting the outcomes data will not know which treatment arm the participant belongs to. Finally, treatment assignment will be coded in the study database until analysis is complete, so that the investigator will be unaware of the treatment assignment until analysis is complete and then un-blinding will occur.
Intervention model description
This 3-arm randomized trial will assign participants 1:1:1 to receive either of two active treatments (acupressure or acupuncture) or placebo (inert adhesive disks applied to ears).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
bullets Inclusion Criteria: * Pregnant up to 13 weeks gestation * Seeking aspiration abortion for any first trimester induced abortion, abnormal pregnancy, early pregnancy loss, retained products of conception, or molar pregnancy * English- or Spanish-speaking * Willingness to be randomized into one of the three arms.
Exclusion criteria
* Allergy to adhesives or gold * Allergy or intolerance to ibuprofen or 1% lidocaine (paracervical block) * Congenital anomaly or infection of the ear.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Visual Analog Scale Score (Beads vs Placebo) | Immediately following the aspiration abortion procedure (approximately 10 minutes) | Self-assessed maximum pain reported using a 0-100mm visual analog scale, where 100 signifies maximum pain. To measure pain experienced during aspiration abortion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Visual Analog Scale Score (Needles vs Placebo) | Immediately following the aspiration abortion procedure (approximately 10 minutes) | Self-assessed maximum pain reported using a 0-100mm visual analog scale, where 100 signifies maximum pain. To measure pain experienced during aspiration abortion. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Visual Analog Scale Score | Immediately following the aspiration abortion procedure (approximately 10 minutes) | Self-assessed maximum anxiety reported using a 0-100 mm visual analog scale, where 100 signifies maximum anxiety. To measure anxiety during aspiration abortion. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 70 |
| 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. | 51 |
| 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. | 52 |
| Total | 173 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Did not have procedure | 3 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Auriculotherapy - Acupressure With Gold Beads | Auriculotherapy - Acupuncture With Pyonex Needles | Placebo Group |
|---|---|---|---|---|
| Age, Continuous | 31.1 years STANDARD_DEVIATION 6.4 | 31.4 years STANDARD_DEVIATION 6.6 | 31.5 years STANDARD_DEVIATION 6.2 | 30.3 years STANDARD_DEVIATION 6.2 |
| Race/Ethnicity, Customized Hispanic | 130 Participants | 55 Participants | 33 Participants | 42 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 19 Participants | 8 Participants | 9 Participants | 2 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 12 Participants | 4 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Other (Asian) | 10 Participants | 3 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized Unknown | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Region of Enrollment United States | 173 Participants | 70 Participants | 51 Participants | 52 Participants |
| Sex: Female, Male Female | 173 Participants | 70 Participants | 51 Participants | 52 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 0 / 51 | 0 / 52 |
| other Total, other adverse events | 0 / 70 | 0 / 51 | 0 / 52 |
| serious Total, serious adverse events | 0 / 70 | 0 / 51 | 0 / 52 |
Outcome results
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.
Time frame: Immediately following the aspiration abortion procedure (approximately 10 minutes)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Auriculotherapy - Acupressure With Gold Beads | Pain Visual Analog Scale Score (Beads vs Placebo) | 50 score on a scale |
| Placebo Group | Pain Visual Analog Scale Score (Beads vs Placebo) | 47.5 score on a scale |
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.
Time frame: Immediately following the aspiration abortion procedure (approximately 10 minutes)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Auriculotherapy - Acupressure With Gold Beads | Pain Visual Analog Scale Score (Needles vs Placebo) | 55 score on a scale |
| Placebo Group | Pain Visual Analog Scale Score (Needles vs Placebo) | 47.5 score on a scale |
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.
Time frame: Immediately following the aspiration abortion procedure (approximately 10 minutes)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Auriculotherapy - Acupressure With Gold Beads | Anxiety Visual Analog Scale Score | 26 score on a scale |
| Placebo Group | Anxiety Visual Analog Scale Score | 28 score on a scale |
| Placebo Group | Anxiety Visual Analog Scale Score | 21 score on a scale |