Actively Recruiting

Phase Not Applicable
Age: 12Years - 50Years
FEMALE
Healthy Volunteers
NCT06240260

TENS Unit for Analgesia During IUD Insertion

Led by Tufts Medical Center · Updated on 2025-06-04

40

Participants Needed

1

Research Sites

87 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Subjects will be screened over the phone or in Tufts GYN clinic for participation in the study. If eligible and interested in participating, written informed consent (and assent if applicable) will be obtained. After informed consent/assent, the patient will be enrolled in the study. The patient will decide if they desire to use TENS unit during IUD insertion appointment and inform the study team. The clinic visit will proceed as normal, with additional study proceedings as follows. The study personnel will complete the 'Background Questionnaire' with the patient prior to IUD insertion. During the IUD insertion appointment, study personnel will assist in collection of the 'Study visit' data collection form. This includes recording the patient's pain score at various time points throughout the insertion procedure: * anticipated pain during IUD insertion * baseline pain prior to insertion * speculum insertion * tenaculum placement * paracervical block administration (if performed) * cervical dilation (if performed) * uterine sounding * IUD insertion * 5 minutes after IUD insertion Study personnel will also time the insertion procedure and collect additional data as outlined in the 'Study visit data collection form.' After IUD insertion, the participant will be asked to complete the 'Post-IUD Insertion Survey.' Once this survey is complete, this will conclude the study participation. Participation will last through the study visit only. As part of the standard of care, a urine pregnancy test will be obtained and confirmed negative prior to IUD insertion. Patients will receive routine pain management modalities per shared decision-making with their clinical provider which may include NSAID administration, paracervical block, and heating pad.

CONDITIONS

Official Title

TENS Unit for Analgesia During IUD Insertion

Who Can Participate

Age: 12Years - 50Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Persons with a uterus desiring insertion of intrauterine device
  • Able to provide informed consent or assent if applicable
  • Age between 12 and 50 years old
  • Minors aged 12 years and older included if postmenarchal
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent or assent
  • Prior cervical procedure such as loop electrosurgical excision procedure (LEEP)
  • Concurrent cervical or intrauterine procedure like colposcopy or dilation and curettage
  • Skin damage at TENS electrode sites
  • Chronic or pre-procedure use of opioids
  • Diagnosis of chronic pain
  • Prior intrauterine device insertion
  • Any contraindication to IUD including pregnancy, uterine anomalies, acute pelvic inflammatory disease, recent postpartum endometritis or infected abortion in past 3 months, unexplained abnormal uterine bleeding, Wilson's disease or copper allergy (for copper IUD), breast cancer (for levonorgestrel IUD)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Tufts Medical Center

Boston, Massachusetts, United States, 02111

Actively Recruiting

Loading map...

Research Team

C

Caitie McCarthy, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

TENS Unit for Analgesia During IUD Insertion | DecenTrialz