Trial Outcomes & Findings for Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Control During First Trimester Abortion (NCT NCT03187002)
NCT ID: NCT03187002
Last Updated: 2020-11-02
Results Overview
Pain with aspiration, assessed by visual analogue scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
109 participants
Primary outcome timeframe
Intraoperative, collected during procedure at the time of aspiration (up to 30 seconds)
Results posted on
2020-11-02
Participant Flow
All recruitment occurred at the Planned Parenthood site.
Participant milestones
| Measure |
Transcutaneous Electrical Nerve Stimulation (TENS)
Transcutaneous electrical nerve stimulation (TENS)
Transcutaneous electrical nerve stimulation (TENS): Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders.
SHAM: Moderate IV Sedation: Sham IV to ensure blinding
|
Moderate IV Sedation
Fentanyl, versed
Moderate IV Sedation: IV sedation with fentanyl and versed
SHAM: Transcutaneous electrical nerve stimulation (TENS): Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
54
|
|
Overall Study
COMPLETED
|
55
|
54
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Control During First Trimester Abortion
Baseline characteristics by cohort
| Measure |
Transcutaneous Electrical Nerve Stimulation (TENS)
n=55 Participants
Transcutaneous electrical nerve stimulation (TENS)
Transcutaneous electrical nerve stimulation (TENS): Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders.
SHAM: Moderate IV Sedation: Sham IV to ensure blinding
|
Moderate IV Sedation
n=54 Participants
Fentanyl, versed
Moderate IV Sedation: IV sedation with fentanyl and versed
SHAM: Transcutaneous electrical nerve stimulation (TENS): Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
28 years
STANDARD_DEVIATION 6 • n=7 Participants
|
27 years
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
54 participants
n=7 Participants
|
109 participants
n=5 Participants
|
|
Gestational Age
|
53 days
n=5 Participants
|
58 days
n=7 Participants
|
55 days
n=5 Participants
|
PRIMARY outcome
Timeframe: Intraoperative, collected during procedure at the time of aspiration (up to 30 seconds)Population: 9 participants required rescue medication (IV sedation with fentanyl and versed) during the procedure in the TENS group and were excluded from per-protocol analysis.
Pain with aspiration, assessed by visual analogue scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")
Outcome measures
| Measure |
Transcutaneous Electrical Nerve Stimulation (TENS)
n=46 Participants
Transcutaneous electrical nerve stimulation (TENS)
Transcutaneous electrical nerve stimulation (TENS): Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders.
SHAM: Moderate IV Sedation: Sham IV to ensure blinding
|
Moderate IV Sedation
n=54 Participants
Fentanyl, versed
Moderate IV Sedation: IV sedation with fentanyl and versed
SHAM: Transcutaneous electrical nerve stimulation (TENS): Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding
|
|---|---|---|
|
Aspiration Pain
|
73 units on a scale
Interval 13.0 to 97.0
|
66 units on a scale
Interval 0.0 to 99.0
|
SECONDARY outcome
Timeframe: Intraoperative, collected during procedure (up to 30 seconds)Population: 9 participants required rescue medication (IV sedation with fentanyl and versed) during the procedure in the TENS group and were excluded from per-protocol analysis.
Pain with speculum placement, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")
Outcome measures
| Measure |
Transcutaneous Electrical Nerve Stimulation (TENS)
n=46 Participants
Transcutaneous electrical nerve stimulation (TENS)
Transcutaneous electrical nerve stimulation (TENS): Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders.
SHAM: Moderate IV Sedation: Sham IV to ensure blinding
|
Moderate IV Sedation
n=54 Participants
Fentanyl, versed
Moderate IV Sedation: IV sedation with fentanyl and versed
SHAM: Transcutaneous electrical nerve stimulation (TENS): Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding
|
|---|---|---|
|
Speculum Placement Pain
|
27 units on a scale
Interval 0.0 to 97.0
|
17.5 units on a scale
Interval 0.0 to 98.0
|
SECONDARY outcome
Timeframe: Intraoperative, collected during procedure (up to 30 seconds)Population: 9 participants required rescue medication (IV sedation with fentanyl and versed) during the procedure in the TENS group and were excluded from per-protocol analysis.
Pain at time of tenaculum placement, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")
Outcome measures
| Measure |
Transcutaneous Electrical Nerve Stimulation (TENS)
n=46 Participants
Transcutaneous electrical nerve stimulation (TENS)
Transcutaneous electrical nerve stimulation (TENS): Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders.
SHAM: Moderate IV Sedation: Sham IV to ensure blinding
|
Moderate IV Sedation
n=54 Participants
Fentanyl, versed
Moderate IV Sedation: IV sedation with fentanyl and versed
SHAM: Transcutaneous electrical nerve stimulation (TENS): Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding
|
|---|---|---|
|
Tenaculum Placement Pain
|
34.5 units on a scale
Interval 0.0 to 82.0
|
23.5 units on a scale
Interval 0.0 to 72.0
|
SECONDARY outcome
Timeframe: Intraoperative, collected during procedure (up to 30 seconds)Population: 9 participants required rescue medication (IV sedation with fentanyl and versed) during the procedure in the TENS group and were excluded from per-protocol analysis.
Pain with paracervical block, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")
Outcome measures
| Measure |
Transcutaneous Electrical Nerve Stimulation (TENS)
n=46 Participants
Transcutaneous electrical nerve stimulation (TENS)
Transcutaneous electrical nerve stimulation (TENS): Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders.
SHAM: Moderate IV Sedation: Sham IV to ensure blinding
|
Moderate IV Sedation
n=54 Participants
Fentanyl, versed
Moderate IV Sedation: IV sedation with fentanyl and versed
SHAM: Transcutaneous electrical nerve stimulation (TENS): Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding
|
|---|---|---|
|
Paracervical Block Pain
|
48.5 units on a scale
Interval 0.0 to 87.0
|
34.5 units on a scale
Interval 3.0 to 81.0
|
SECONDARY outcome
Timeframe: Intraoperative, collected during procedure (up to 30 seconds)Population: 9 participants required rescue medication (IV sedation with fentanyl and versed) during the procedure in the TENS group and were excluded from per-protocol analysis.
Pain with manual cervical dilation, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")
Outcome measures
| Measure |
Transcutaneous Electrical Nerve Stimulation (TENS)
n=46 Participants
Transcutaneous electrical nerve stimulation (TENS)
Transcutaneous electrical nerve stimulation (TENS): Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders.
SHAM: Moderate IV Sedation: Sham IV to ensure blinding
|
Moderate IV Sedation
n=54 Participants
Fentanyl, versed
Moderate IV Sedation: IV sedation with fentanyl and versed
SHAM: Transcutaneous electrical nerve stimulation (TENS): Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding
|
|---|---|---|
|
Manual Cervical Dilation Pain
|
67 units on a scale
Interval 11.0 to 94.0
|
56 units on a scale
Interval 0.0 to 99.0
|
SECONDARY outcome
Timeframe: Intraoperative, collected during procedure (up to 30 seconds)Population: 9 participants required rescue medication (IV sedation with fentanyl and versed) during the procedure in the TENS group and were excluded from per-protocol analysis.
Pain with speculum removal, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")
Outcome measures
| Measure |
Transcutaneous Electrical Nerve Stimulation (TENS)
n=46 Participants
Transcutaneous electrical nerve stimulation (TENS)
Transcutaneous electrical nerve stimulation (TENS): Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders.
SHAM: Moderate IV Sedation: Sham IV to ensure blinding
|
Moderate IV Sedation
n=54 Participants
Fentanyl, versed
Moderate IV Sedation: IV sedation with fentanyl and versed
SHAM: Transcutaneous electrical nerve stimulation (TENS): Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding
|
|---|---|---|
|
Speculum Removal Pain
|
38.5 units on a scale
Interval 0.0 to 83.0
|
23 units on a scale
Interval 0.0 to 94.0
|
SECONDARY outcome
Timeframe: Intraoperative, collected during procedure (up to 20 minutes)Population: 9 participants required rescue medication (IV sedation with fentanyl and versed) during the procedure in the TENS group and were excluded from per-protocol analysis.
Time from speculum placement to speculum removal, measured in minutes
Outcome measures
| Measure |
Transcutaneous Electrical Nerve Stimulation (TENS)
n=46 Participants
Transcutaneous electrical nerve stimulation (TENS)
Transcutaneous electrical nerve stimulation (TENS): Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders.
SHAM: Moderate IV Sedation: Sham IV to ensure blinding
|
Moderate IV Sedation
n=54 Participants
Fentanyl, versed
Moderate IV Sedation: IV sedation with fentanyl and versed
SHAM: Transcutaneous electrical nerve stimulation (TENS): Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding
|
|---|---|---|
|
Total Procedure Time
|
7 minutes
Interval 3.5 to 16.5
|
6.4 minutes
Interval 3.3 to 16.4
|
Adverse Events
Transcutaneous Electrical Nerve Stimulation (TENS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Moderate IV Sedation
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