TENS Unit To Decrease Pain After Laminaria Insertion

NARecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

August 14, 2024

Primary Completion Date

October 31, 2025

Study Completion Date

November 30, 2025

Conditions
Second Trimester Abortion
Interventions
DEVICE

Transcutaneous Electrical Nerve Stimulation (TENS) unit

All participants in this study will receive the standard of care, which includes oral ibuprofen and a paracervical block at the time of laminaria insertion. Those in the treatment group will receive an adjunctive TENS unit with specific instructions for use in the interval between laminaria insertion and dilation and evacuation the next day. TENS is a non-invasive, inexpensive, over-the-counter, nonpharmacologic option to relieve pain. All participants will be provided with 15 tabs of ibuprofen 200 mg for outpatient pain control after the procedure. Participants will be instructed to take 600-800 mg of ibuprofen with food every 6 hours as needed for pain during the time period after laminaria insertion and before dilation and evacuation surgery, which is generally less than 24 hours.

DEVICE

Placebo

Participants in the placebo group will be given a TENS unit without a battery with similar to the intervention group but will be advised that they may or may not feel a sensation from the electrodes. All participants will be provided with 15 tabs of ibuprofen 200 mg for outpatient pain control after the procedure. Participants will be instructed to take 600-800 mg of ibuprofen with food every 6 hours as needed for pain during the time period after laminaria insertion and before dilation and evacuation surgery, which is generally less than 24 hours.

Trial Locations (1)

96813

RECRUITING

1380 Lusitana St. Ste 1004, Honolulu

All Listed Sponsors
collaborator

University of Hawaii Foundation

UNKNOWN

lead

Queen's Medical Center

OTHER