Using TENS units to reduce pain during IUD insertion
Utilization of Transcutaneous Electrical Nerve Stimulation (TENS) Unit for Analgesia During IUD Insertion: A Prospective Cohort Study
NA · Tufts Medical Center · NCT06240260
This study is testing if using TENS units can help reduce pain for women aged 12 to 50 during IUD insertion.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 12 Years to 50 Years |
| Sex | Female |
| Sponsor | Tufts Medical Center (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06240260 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of transcutaneous electrical nerve stimulation (TENS) units in managing pain during the insertion of intrauterine devices (IUDs). Eligible participants, aged 12 to 50, will be screened and consented before deciding whether to use the TENS unit during their IUD insertion appointment. Pain levels will be assessed at various stages of the procedure to determine the impact of TENS on pain management. The study aims to provide insights into patient preferences and pain experiences associated with IUD insertion.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 12 to 50 with a uterus who desire an IUD and can provide informed consent.
Not a fit: Patients with contraindications to IUD insertion or those with chronic pain conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain and improve the overall experience of IUD insertion for patients.
How similar studies have performed: While the use of TENS for pain management is established in other contexts, its application specifically for IUD insertion is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Persons with a uterus desiring insertion of intrauterine device 2. Able to provide informed consent/assent 3. Age 12-50 years old 4. Minors 12 years of age and older will be included in the study if postmenarchal Exclusion Criteria: 1. Unable to provide informed consent/assent 2. Prior cervical procedure (ie loop electrosurgical excision procedure, LEEP) 3. Concurrent cervical or intrauterine procedure (ie colposcopy or dilation and curettage) 4. Cutaneous damage at the TENS electrode sites 5. Chronic or pre-procedure use of opioids 6. Chronic pain diagnosis 7. Prior IUD insertion 8. Any contraindication to intrauterine device (IUD): 1. Pregnancy 2. Uterine anomaly that distorts the uterine cavity 3. Acute pelvic inflammatory disease (PID) 4. Postpartum endometritis or infected abortion in the past 3 months 5. Unexplained abnormal uterine bleeding 6. Wilson's disease or copper allergy (contraindication to copper IUD only) 7. Breast cancer (contraindication to levonorgestrel IUD only
Where this trial is running
Boston, Massachusetts
- Tufts Medical Center — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Andrea Zuckerman, MD — Tufts Medical Center
- Study coordinator: Caitie McCarthy, MD
- Email: caitlin.mccarthy@tuftsmedicine.org
- Phone: 617-636-9897
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: IUD, Analgesia, Patient Preference, Pain, Acute, iud, contraception, iud placement, pain management