CompletedNot Applicable

TENS Unit To Decrease Pain After Laminaria Insertion

United States36 participantsStarted 2024-08-14

Plain-language summary

The purpose of the study is to learn more about the transcutaneous nerve stimulation (TENS) unit, an over-the-counter option for pain relief that is not a medication. The investigators are hoping to find out if this device decreases pain during and after laminaria placement for patients undergoing both elective and medically indicated second-trimester termination of pregnancy.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients undergoing laminaria insertion for D\&E procedure * Age 18 years or older * Capability and willingness to send and receive SMS messages by phone and complete web-based surveys * Capability to read and understand directions for using a TENS unit * Capability to operate a TENS unit according to provided directions Exclusion Criteria: * Inability to complete the informed consent in English * Exposure to adjunctive pharmacologic cervical preparation (misoprostol or mifepristone) within 48 hours of the D\&E procedure * Contraindication to ibuprofen or bupivacaine * Contraindication to TENS, including cardiac pacemakers, epilepsy, bleeding disorders, cancer, and concurrent use near transdermal drug delivery systems * Previous participation in this trial * Prior use of TENS unit

What they're measuring

Maximum pain scores

Timeframe: Between osmotic dilator placement and dilation and evacuation procedure (approximately 16-24 hours)

Trial details

NCT IDNCT06529003

SponsorQueen's Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-05

View on ClinicalTrials.gov More Second Trimester Abortion trials