Trial Outcomes & Findings for Auriculotherapy - Pain Management of Aspiration Abortion (NCT NCT03896022)
NCT ID: NCT03896022
Last Updated: 2021-02-09
Results Overview
Self-assessed maximum pain reported using a 0-100mm visual analog scale, where 100 signifies maximum pain. To measure pain experienced during aspiration abortion.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
177 participants
Primary outcome timeframe
Immediately following the aspiration abortion procedure (approximately 10 minutes)
Results posted on
2021-02-09
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
74
|
51
|
52
|
|
Overall Study
COMPLETED
|
70
|
51
|
52
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Did not have procedure
|
3
|
0
|
0
|
Baseline Characteristics
Auriculotherapy - Pain Management of Aspiration Abortion
Baseline characteristics by cohort
| Measure |
Auriculotherapy - Acupressure With Gold Beads
n=70 Participants
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.
|
Auriculotherapy - Acupuncture With Pyonex Needles
n=51 Participants
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.
|
Placebo Group
n=52 Participants
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.
|
Total
n=173 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
31.4 years
STANDARD_DEVIATION 6.6 • n=99 Participants
|
31.5 years
STANDARD_DEVIATION 6.2 • n=107 Participants
|
30.3 years
STANDARD_DEVIATION 6.2 • n=206 Participants
|
31.1 years
STANDARD_DEVIATION 6.4 • n=7 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
173 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
|
|
Race/Ethnicity, Customized
Hispanic
|
55 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
130 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other (Asian)
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
70 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
173 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Auriculotherapy - Acupressure With Gold Beads
n=70 Participants
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.
|
Placebo Group
n=52 Participants
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.
|
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.
|
|---|---|---|---|
|
Pain Visual Analog Scale Score (Beads vs Placebo)
|
50 score on a scale
Interval 23.0 to 75.5
|
47.5 score on a scale
Interval 31.3 to 73.0
|
—
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Auriculotherapy - Acupressure With Gold Beads
n=51 Participants
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.
|
Placebo Group
n=52 Participants
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.
|
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.
|
|---|---|---|---|
|
Pain Visual Analog Scale Score (Needles vs Placebo)
|
55 score on a scale
Interval 28.0 to 78.0
|
47.5 score on a scale
Interval 31.3 to 73.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Auriculotherapy - Acupressure With Gold Beads
n=70 Participants
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.
|
Placebo Group
n=51 Participants
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.
|
Placebo Group
n=52 Participants
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.
|
|---|---|---|---|
|
Anxiety Visual Analog Scale Score
|
26 score on a scale
Interval 12.8 to 50.0
|
28 score on a scale
Interval 10.0 to 65.0
|
21 score on a scale
Interval 0.0 to 56.0
|
Adverse Events
Auriculotherapy - Acupressure With Gold Beads
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Auriculotherapy - Acupuncture With Pyonex Needles
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Group
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place