N/A
N=60
Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Reduction During Intrauterine Device (IUD) Insertion in Outpatient Gynecology
IUD Insertion Pain
Bottom Line
View on ClinicalTrials.gov: NCT06335823 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Pain During IUD Insertion as Measured by the VAS Score — 6.46; 5.63 score on a scale — p=0.2187
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcutaneous electrical nerve stimulation (TENS) (Device); Placebo Transcutaneous electrical nerve stimulation (TENS) (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University Hospitals Cleveland Medical Center
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain During IUD Insertion as Measured by the VAS Score |
6.00; 4.73; 5.80; 3.20 | 0.370 |
| SECONDARY Pain During IUD Insertion as Measured by the VAS Score |
6.00; 4.73; 5.80; 3.20 | 0.370 |
| SECONDARY Pain During IUD Insertion as Measured by the VAS Score |
6.00; 4.73; 5.80; 3.20 | 0.370 |
| SECONDARY Pain During IUD Insertion as Measured by the VAS Score |
6.00; 4.73; 5.80; 3.20 | 0.370 |
| SECONDARY Pain Post IUD Insertion as Measured by the VAS Score |
2.81; 2.82; 2.00; 6.40 | 0.099 |
Summary
Pain with intrauterine device (IUD) insertion is very common and there are few options for patients to help reduce this pain. Transcutaneous electric nerve stimulators (TENS) are a non-invasive procedure that may help reduce the pain with IUD insertions. The investigators hope that the information gleaned from this study will result in pain control options for future patients who desire an IUD placement.
Eligibility Criteria
Inclusion Criteria
- Age 18-45 years old
- Individuals with a cervix and uterus
- Seeking intrauterine device (IUD) placement for contraception or management of abnormal uterine bleeding
- Meet medical eligibility for IUD placement
- Ability to consent in English
- Ability to use the visual analogue scale (VAS)
Exclusion Criteria
- Contraindications to IUD placement
- Use of analgesics within the last 4 hours prior to IUD placement
- Presence of a pacemaker
Data sourced from ClinicalTrials.gov (NCT06335823). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.