TENS Unit To Decrease Pain After Laminaria Insertion

Completed · Not applicable · Has a placebo group

Conditions studied: Second Trimester Abortion

In brief

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.

Key facts

Study ID

NCT06529003

Run by

Queen's Medical Center

People needed

36

Starts

2024-08-14

Expected to finish

2025-11-05

Last updated by the study team

2025-12-16

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 1380 Lusitana St. Ste 1004 — Honolulu, Hawaii, United States

Full record on ClinicalTrials.gov

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