Trial Outcomes & Findings for Auriculotherapy During Medication Abortion (NCT NCT03900728)
NCT ID: NCT03900728
Last Updated: 2021-07-06
Results Overview
Self-assessed maximum pain reported using a 0-100 mm visual analog scale (VAS), where 100 signifies maximum pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
138 participants
Primary outcome timeframe
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).
Results posted on
2021-07-06
Participant Flow
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).
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
57
|
39
|
|
Overall Study
COMPLETED
|
40
|
57
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
4
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
No text responses
|
0
|
0
|
4
|
Baseline Characteristics
Auriculotherapy During Medication Abortion
Baseline characteristics by cohort
| Measure |
Auriculotherapy With Needles (Acupuncture) + Usual Care
n=40 Participants
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.
|
Auriculotherapy With Gold Beads (Acupressure) + Usual Care
n=57 Participants
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.
|
Placebo Group + Usual Care
n=39 Participants
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.
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
26.7 years
STANDARD_DEVIATION 5.8 • n=99 Participants
|
28.6 years
STANDARD_DEVIATION 7.0 • n=107 Participants
|
27.3 years
STANDARD_DEVIATION 5.9 • n=206 Participants
|
27.67 years
STANDARD_DEVIATION 6.37 • n=7 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
136 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
35 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
121 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=99 Participants
|
57 participants
n=107 Participants
|
39 participants
n=206 Participants
|
136 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Auriculotherapy With Needles (Acupuncture) + Usual Care
n=40 Participants
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.
|
Auriculotherapy With Gold Beads (Acupressure) + Usual Care
n=57 Participants
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.
|
Placebo Group + Usual Care
n=39 Participants
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.
|
|---|---|---|---|
|
Pain VAS Score
|
75 score on a scale
Interval 45.0 to 90.0
|
60 score on a scale
Interval 20.0 to 85.0
|
55 score on a scale
Interval 30.0 to 85.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Auriculotherapy With Needles (Acupuncture) + Usual Care
n=40 Participants
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.
|
Auriculotherapy With Gold Beads (Acupressure) + Usual Care
n=57 Participants
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.
|
Placebo Group + Usual Care
n=39 Participants
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.
|
|---|---|---|---|
|
Anxiety VAS Score
|
45 score on a scale
Interval 0.0 to 60.0
|
10 score on a scale
Interval 0.0 to 50.0
|
30 score on a scale
Interval 0.0 to 50.0
|
Adverse Events
Auriculotherapy With Needles (Acupuncture) + Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Auriculotherapy With Gold Beads (Acupressure) + Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Group + Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Carolyn Westhoff, MD
Columbia University Irving Medical Center
Phone: 2123057070
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place