TENS Unit To Decrease Pain After Laminaria Insertion
NCT Number: NCT06529003
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Second Trimester Abortion
Interventions: DEVICE: Transcutaneous Electrical Nerve Stimulation (TENS) unit|DEVICE: Placebo
Sponsor: Queen's Medical Center
Collaborators: University of Hawaii Foundation
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08
Completion Date: 2025-05
Locations: 1380 Lusitana St. Ste 1004, Honolulu, Hawaii, 96813, United States

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.

Primary Outcome Measures: Maximum pain scores, To compare the maximum pain scores reported during the interval between osmotic dilator placement and D\&E procedure of patients receiving the standard of care plus placebo and those who use an adjunctive transcutaneous electrical nerve stimulation (TENS) unit in addition to standard of care. Participants will be asked to rank their pain on an 11-point numerical rating scale (0 to 10), with higher numbers indicating worse pain., Between osmotic dilator placement and dilation and evacuation procedure (approximately 16-24 hours)
Secondary Outcome Measures: Pain at time of laminaria insertion, Pain scores at the time of laminaria insertion. Participants will be asked to rank their pain on an 11-point numerical rating scale (0 to 10), with higher numbers indicating worse pain., At time of laminaria insertion|Number of TENS sessions, Number of TENS sessions, Between osmotic dilator placement and dilation and evacuation procedure (approximately 16-24 hours)|Duration of each TENS sessions, Duration of each TENS sessions, Between osmotic dilator placement and dilation and evacuation procedure (approximately 16-24 hours)|Satisfaction with pain management, Participants will be asked "Overall satisfaction with pain control since the procedure: (0-10 numeric rating scale)" on all five surveys. A score of 0 indicates "extremely unsatisfied." A score of 5 indicates "neutral." A score of 10 indicates "extremely satisfied.", Between osmotic dilator placement and dilation and evacuation procedure (approximately 16-24 hours)|Ease of use, Perception of the ease of use of the TENS unit. At the initial 10-minute mark survey, participants will be asked, "How difficult do you feel it will be to use a TENS unit? (0-10 numeric rating scale)". On the final survey (pre-op survey), only participants in the intervention group will be asked, "How difficult was it to use a TENS unit? (0-10 numeric rating scale)". A score of 0 indicates "not difficult at all." A score of 10 indicates "very difficult.", Between osmotic dilator placement and dilation and evacuation procedure (approximately 16-24 hours)|Analgesic use, Amount of ibuprofen taken and/or other analgesics, Between osmotic dilator placement and dilation and evacuation procedure (approximately 16-24 hours)