Abortion Early
Conditions
Brief summary
This randomized trial will evaluate the effect of adding auriculotherapy (i.e. acupuncture applied to the ear) using either gold beads or Pyonex needles in addition to usual care for the relief of pain and anxiety during medication abortion. The control group will receive placebo auriculotherapy plus usual care. Participants will receive the assigned treatment immediately after they receive their initial abortion medication. The investigators will assess pain and anxiety via text message once daily for four days, and in person at a one-week follow-up visit.
Detailed description
Most women undergoing medication abortion with mifepristone and misoprostol report moderate to severe pain, despite treatment with ibuprofen or opioids. In 2018 National Academies of Sciences, Engineering and Medicine (NASEM) recommended research to improve pain relief. Limited data indicate that acupuncture is valuable for dysmenorrhea and for labor pain, conditions in which pain may be similar to that experienced during medication abortion. This randomized trial will recruit women seeking medication abortion after they have completed their routine clinical assessment and after they have received mifepristone. This study will evaluate two types of auriculotherapy applied to selected acupoints on the external ear. The study treatments are acupuncture using Pyonex needles and acupressure using gold pellets; both are applied to the ear using adhesive disks. A control group will receive the adhesive disks alone. All participants will receive usual medication abortion care, including taking misoprostol 1-3 days after mifepristone and ibuprofen for pain management. The investigators will query the participants regarding pain and anxiety. Follow-up will end at the time of the usual clinical follow-up about one week after mifepristone administration.
Interventions
DEVICEAuriculotherapy with needles
Single-use 1.2mm acupuncture press needles attach to pre-specified acupoints on the participant's ears with adhesive disk/tape.
DEVICEAuriculotherapy with beads
A trained co-investigator will place the beads onto prespecified acupoints of the participant's ears. An adhesive disk will adhere the beads to the ears.
DEVICEPlacebo Adhesive disks
Single-use adhesive disks without needles or beads.
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
A separate investigator will apply the intervention after the initial usual care is complete and participants will go home using the intervention; thus the care provider will not be aware of the treatment. 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 (acupuncture or acupressure) or placebo (insert adhesive disks applied to ears).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Pregnant up to 10 weeks (70 days) gestation * Seeking medication abortion with mifepristone and misoprostol * Initial clinical care completed and mifepristone administered * English- or Spanish-speaking * Able to use a mobile phone for follow-up on days 1-4
Exclusion criteria
* Not a candidate for medication abortion for any reason * Allergy to adhesives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain VAS Score | Auriculotherapy is applied on the day of mifepristone. Participants take misoprostol 1-3 days later. Pain scores are recorded following misoprostol at 8pm x 4 days (selecting the highest of the 4 for analysis). | Self-assessed maximum pain reported using a 0-100 mm visual analog scale (VAS), where 100 signifies maximum pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety VAS Score | Auriculotherapy is applied on the day of mifepristone. Participants take misoprostol 1-3 days later. Anxiety scores are recorded following misoprostol at 8pm x 4 days (selecting the highest of 4 for analysis). | Self-assessed maximum anxiety reported using a 0-100 mm visual analog scale, where 100 signifies maximum anxiety. |
Countries
United States
Participant flow
Pre-assignment details
Out of 138 enrolled subjects, 2 subjects were not randomized. 1 subject did not have a study auriculotherapist available during the visit and 1 subject declined randomization. Only data information for the randomized subjects were analyzed (n = 136).
Participants by arm
| Arm | Count |
|---|---|
| Auriculotherapy With Needles (Acupuncture) + Usual Care A designated trained therapist will perform auriculotherapy with 1mm (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 until removal at the 1-week follow-up visit
Auriculotherapy with needles: Single-use 1.2mm acupuncture press needles attach to pre-specified acupoints on the participant's ears with adhesive disk/tape. | 40 |
| Auriculotherapy With Gold Beads (Acupressure) + Usual Care A designated trained therapist will perform auriculotherapy with 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 until removal at the 1-week follow-up visit.
Auriculotherapy with beads: A trained co-investigator will place the beads onto prespecified acupoints of the participant's ears. An adhesive disk will adhere the beads to the ears. | 57 |
| Placebo Group + Usual Care A designated trained therapist 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 until removal at the 1-week follow-up visit.
Placebo Adhesive disks: Single-use adhesive disks without needles or beads. | 39 |
| Total | 136 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | No text responses | 0 | 0 | 4 |
Baseline characteristics
| Characteristic | Auriculotherapy With Needles (Acupuncture) + Usual Care | Auriculotherapy With Gold Beads (Acupressure) + Usual Care | Placebo Group + Usual Care | Total |
|---|---|---|---|---|
| Age, Continuous | 26.7 years STANDARD_DEVIATION 5.8 | 28.6 years STANDARD_DEVIATION 7 | 27.3 years STANDARD_DEVIATION 5.9 | 27.67 years STANDARD_DEVIATION 6.37 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 35 Participants | 51 Participants | 35 Participants | 121 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 6 Participants | 4 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 40 participants | 57 participants | 39 participants | 136 participants |
| Sex: Female, Male Female | 40 Participants | 57 Participants | 39 Participants | 136 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 / 40 | 0 / 57 | 0 / 39 |
| other Total, other adverse events | 0 / 40 | 0 / 57 | 0 / 39 |
| serious Total, serious adverse events | 0 / 40 | 0 / 57 | 0 / 39 |
Outcome results
Primary
Pain VAS Score
Self-assessed maximum pain reported using a 0-100 mm visual analog scale (VAS), where 100 signifies maximum pain.
Time frame: Auriculotherapy is applied on the day of mifepristone. Participants take misoprostol 1-3 days later. Pain scores are recorded following misoprostol at 8pm x 4 days (selecting the highest of the 4 for analysis).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Auriculotherapy With Needles (Acupuncture) + Usual Care | Pain VAS Score | 75 score on a scale |
| Auriculotherapy With Gold Beads (Acupressure) + Usual Care | Pain VAS Score | 60 score on a scale |
| Placebo Group + Usual Care | Pain VAS Score | 55 score on a scale |
Secondary
Anxiety VAS Score
Self-assessed maximum anxiety reported using a 0-100 mm visual analog scale, where 100 signifies maximum anxiety.
Time frame: Auriculotherapy is applied on the day of mifepristone. Participants take misoprostol 1-3 days later. Anxiety scores are recorded following misoprostol at 8pm x 4 days (selecting the highest of 4 for analysis).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Auriculotherapy With Needles (Acupuncture) + Usual Care | Anxiety VAS Score | 45 score on a scale |
| Auriculotherapy With Gold Beads (Acupressure) + Usual Care | Anxiety VAS Score | 10 score on a scale |
| Placebo Group + Usual Care | Anxiety VAS Score | 30 score on a scale |