TENS Unit for Analgesia During IUD Insertion

Launched by TUFTS MEDICAL CENTER · Jan 31, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of a TENS unit, a device that delivers mild electrical pulses to help relieve pain, during the insertion of an intrauterine device (IUD). The goal is to see if using the TENS unit can help lessen the pain women experience during this procedure. To participate, women aged 12 to 50 who are planning to get an IUD and can provide consent are eligible. However, some individuals may not qualify, such as those with certain medical conditions, prior cervical procedures, or those currently pregnant.

If you choose to participate, you will first complete a background questionnaire and then decide if you want to use the TENS unit during your IUD insertion appointment. Throughout the appointment, staff will record your pain levels at various points to assess how effective the TENS unit is. After the procedure, you will fill out a survey about your experience. Participation is limited to this one visit, and your standard care will include routine pain management options discussed with your healthcare provider.

Gender

FEMALE

Eligibility 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