Trial Outcomes & Findings for Transcutaneous Electrical Nerve Stimulation (TENS) for IUD Insertion Pain (NCT NCT06245655)
NCT ID: NCT06245655
Last Updated: 2026-07-06
Results Overview
Participant reported maximum pain score on Pain Visual Analog Scale - full scale from 0-100, higher score indicates higher level of pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
99 participants
Primary outcome timeframe
Day 1 (Day of IUD Insertion)
Results posted on
2026-07-06
Participant Flow
Participant milestones
| Measure |
Active TENS
For the Active TENS group, the device will be set to 80 Hz (hfTENS) and device intensity (0-8) will be titrated to patient comfort, as is the standard protocol for TENS use.
Transcutaneous Electrical Nerve Stimulation (TENS): TENS 7000 digital TENS unit, a low cost, over the counter, battery operated device with high consumer ratings. The handheld device works by transmitting an electronically generated topical stimulus to a specified area on the body to alter response to pain signals and promote endogenous endorphin release for pain reduction.
|
Placebo TENS
For the placebo TENS group, setup will be identical, but the device will not be turned on.
Transcutaneous Electrical Nerve Stimulation (TENS): TENS 7000 digital TENS unit, a low cost, over the counter, battery operated device with high consumer ratings. The handheld device works by transmitting an electronically generated topical stimulus to a specified area on the body to alter response to pain signals and promote endogenous endorphin release for pain reduction.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
50
|
|
Overall Study
COMPLETED
|
48
|
50
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Active TENS
For the Active TENS group, the device will be set to 80 Hz (hfTENS) and device intensity (0-8) will be titrated to patient comfort, as is the standard protocol for TENS use.
Transcutaneous Electrical Nerve Stimulation (TENS): TENS 7000 digital TENS unit, a low cost, over the counter, battery operated device with high consumer ratings. The handheld device works by transmitting an electronically generated topical stimulus to a specified area on the body to alter response to pain signals and promote endogenous endorphin release for pain reduction.
|
Placebo TENS
For the placebo TENS group, setup will be identical, but the device will not be turned on.
Transcutaneous Electrical Nerve Stimulation (TENS): TENS 7000 digital TENS unit, a low cost, over the counter, battery operated device with high consumer ratings. The handheld device works by transmitting an electronically generated topical stimulus to a specified area on the body to alter response to pain signals and promote endogenous endorphin release for pain reduction.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Transcutaneous Electrical Nerve Stimulation (TENS) for IUD Insertion Pain
Baseline characteristics by cohort
| Measure |
Active TENS
n=48 Participants
For the Active TENS group, the device will be set to 80 Hz (hfTENS) and device intensity (0-8) will be titrated to patient comfort, as is the standard protocol for TENS use.
Transcutaneous Electrical Nerve Stimulation (TENS): TENS 7000 digital TENS unit, a low cost, over the counter, battery operated device with high consumer ratings. The handheld device works by transmitting an electronically generated topical stimulus to a specified area on the body to alter response to pain signals and promote endogenous endorphin release for pain reduction.
|
Placebo TENS
n=50 Participants
For the placebo TENS group, setup will be identical, but the device will not be turned on.
Transcutaneous Electrical Nerve Stimulation (TENS): TENS 7000 digital TENS unit, a low cost, over the counter, battery operated device with high consumer ratings. The handheld device works by transmitting an electronically generated topical stimulus to a specified area on the body to alter response to pain signals and promote endogenous endorphin release for pain reduction.
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.0 years
n=9 Participants
|
28.0 years
n=27 Participants
|
29.0 years
n=267 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=9 Participants
|
50 Participants
n=27 Participants
|
98 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=9 Participants
|
18 Participants
n=27 Participants
|
40 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=9 Participants
|
28 Participants
n=27 Participants
|
52 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
11 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=9 Participants
|
18 Participants
n=27 Participants
|
29 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=9 Participants
|
19 Participants
n=27 Participants
|
36 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
17 Participants
n=267 Participants
|
|
Education Level
Some High School
|
2 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Education Level
High School/GED Equivalent
|
15 Participants
n=9 Participants
|
17 Participants
n=27 Participants
|
32 Participants
n=267 Participants
|
|
Education Level
Trade School
|
1 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
|
Education Level
Bachelor's Degree
|
18 Participants
n=9 Participants
|
20 Participants
n=27 Participants
|
38 Participants
n=267 Participants
|
|
Education Level
Master's Degree
|
9 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
14 Participants
n=267 Participants
|
|
Education Level
Doctorate or Higher
|
1 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Education Level
Prefer not to say
|
2 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Insurance
Commercial Insurance
|
23 Participants
n=9 Participants
|
23 Participants
n=27 Participants
|
46 Participants
n=267 Participants
|
|
Insurance
Medicaid Managed Care
|
22 Participants
n=9 Participants
|
25 Participants
n=27 Participants
|
47 Participants
n=267 Participants
|
|
Insurance
Medicare
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Insurance
Self-pay
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Insurance
Straight Medicaid
|
2 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Body Mass Index (BMI)
|
24.5 Kg/m^2
n=9 Participants
|
27.3 Kg/m^2
n=27 Participants
|
26.4 Kg/m^2
n=267 Participants
|
|
Medical History
None
|
26 Participants
n=9 Participants
|
30 Participants
n=27 Participants
|
56 Participants
n=267 Participants
|
|
Medical History
Anxiety
|
20 Participants
n=9 Participants
|
10 Participants
n=27 Participants
|
30 Participants
n=267 Participants
|
|
Medical History
Depression
|
13 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
21 Participants
n=267 Participants
|
|
Medical History
Not counted
|
0 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Nulliparous
|
27 Participants
n=9 Participants
|
28 Participants
n=27 Participants
|
55 Participants
n=267 Participants
|
|
Parous
|
25 Participants
n=9 Participants
|
27 Participants
n=27 Participants
|
52 Participants
n=267 Participants
|
|
Previous Vaginal Delivery
|
21 Participants
n=9 Participants
|
22 Participants
n=27 Participants
|
43 Participants
n=267 Participants
|
|
Previous Cesarean section only
|
4 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
9 Participants
n=267 Participants
|
|
Moderate to severe cramping with periods
|
21 Participants
n=9 Participants
|
20 Participants
n=27 Participants
|
41 Participants
n=267 Participants
|
|
Heavy periods
|
18 Participants
n=9 Participants
|
19 Participants
n=27 Participants
|
37 Participants
n=267 Participants
|
|
Previous IUD
|
19 Participants
n=9 Participants
|
14 Participants
n=27 Participants
|
33 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: Day 1 (Day of IUD Insertion)Participant reported maximum pain score on Pain Visual Analog Scale - full scale from 0-100, higher score indicates higher level of pain.
Outcome measures
| Measure |
Active TENS
n=48 Participants
For the Active TENS group, the device will be set to 80 Hz (hfTENS) and device intensity (0-8) will be titrated to patient comfort, as is the standard protocol for TENS use.
Transcutaneous Electrical Nerve Stimulation (TENS): TENS 7000 digital TENS unit, a low cost, over the counter, battery operated device with high consumer ratings. The handheld device works by transmitting an electronically generated topical stimulus to a specified area on the body to alter response to pain signals and promote endogenous endorphin release for pain reduction.
|
Placebo TENS
n=50 Participants
For the placebo TENS group, setup will be identical, but the device will not be turned on.
Transcutaneous Electrical Nerve Stimulation (TENS): TENS 7000 digital TENS unit, a low cost, over the counter, battery operated device with high consumer ratings. The handheld device works by transmitting an electronically generated topical stimulus to a specified area on the body to alter response to pain signals and promote endogenous endorphin release for pain reduction.
|
|---|---|---|
|
Pain Score on Pain Visual Analog Scale
|
50.8 score on a scale
Standard Deviation 26.9
|
50.6 score on a scale
Standard Deviation 29.2
|
SECONDARY outcome
Timeframe: Day 1 (Day of IUD Insertion)Participant reported maximum pain score on Pain Visual Analog Scale - full scale from 0-100, higher score indicates higher level of pain.
Outcome measures
| Measure |
Active TENS
n=48 Participants
For the Active TENS group, the device will be set to 80 Hz (hfTENS) and device intensity (0-8) will be titrated to patient comfort, as is the standard protocol for TENS use.
Transcutaneous Electrical Nerve Stimulation (TENS): TENS 7000 digital TENS unit, a low cost, over the counter, battery operated device with high consumer ratings. The handheld device works by transmitting an electronically generated topical stimulus to a specified area on the body to alter response to pain signals and promote endogenous endorphin release for pain reduction.
|
Placebo TENS
n=50 Participants
For the placebo TENS group, setup will be identical, but the device will not be turned on.
Transcutaneous Electrical Nerve Stimulation (TENS): TENS 7000 digital TENS unit, a low cost, over the counter, battery operated device with high consumer ratings. The handheld device works by transmitting an electronically generated topical stimulus to a specified area on the body to alter response to pain signals and promote endogenous endorphin release for pain reduction.
|
|---|---|---|
|
Maximum Pain Score on Pain Visual Analog Scale
|
57.6 score on a scale
Standard Deviation 26.2
|
63.2 score on a scale
Standard Deviation 24.1
|
SECONDARY outcome
Timeframe: Day 1 (Day of IUD Insertion)Acceptability of the TENS device. Questions answered as yes or no. This is not a scale and has no min or max score.
Outcome measures
| Measure |
Active TENS
n=48 Participants
For the Active TENS group, the device will be set to 80 Hz (hfTENS) and device intensity (0-8) will be titrated to patient comfort, as is the standard protocol for TENS use.
Transcutaneous Electrical Nerve Stimulation (TENS): TENS 7000 digital TENS unit, a low cost, over the counter, battery operated device with high consumer ratings. The handheld device works by transmitting an electronically generated topical stimulus to a specified area on the body to alter response to pain signals and promote endogenous endorphin release for pain reduction.
|
Placebo TENS
n=50 Participants
For the placebo TENS group, setup will be identical, but the device will not be turned on.
Transcutaneous Electrical Nerve Stimulation (TENS): TENS 7000 digital TENS unit, a low cost, over the counter, battery operated device with high consumer ratings. The handheld device works by transmitting an electronically generated topical stimulus to a specified area on the body to alter response to pain signals and promote endogenous endorphin release for pain reduction.
|
|---|---|---|
|
Post Procedure Survey Question - Acceptability of the Device
|
44 Participants
|
38 Participants
|
Adverse Events
Active TENS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo TENS
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