36
Participants
Start Date
August 14, 2024
Primary Completion Date
October 31, 2025
Study Completion Date
November 30, 2025
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.
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.
RECRUITING
1380 Lusitana St. Ste 1004, Honolulu
University of Hawaii Foundation
UNKNOWN
Queen's Medical Center
OTHER