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.
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 sham placebo and those who use an adjunctive Transcutaneous electrical nerve stimulation (TENS) unit in addition to standard of care. Secondary objectives include comparing pain scores at the time of laminaria insertion, assessing the number and duration of TENS sessions, additional analgesic use, satisfaction with pain management, and patient perception of the ease of use of the TENS unit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
36
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.
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.
1380 Lusitana St. Ste 1004
Honolulu, Hawaii, United States
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.
Time frame: Between osmotic dilator placement and dilation and evacuation procedure (approximately 16-24 hours)
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.
Time frame: At time of laminaria insertion
Number of TENS sessions
Number of TENS sessions
Time frame: Between osmotic dilator placement and dilation and evacuation procedure (approximately 16-24 hours)
Duration of each TENS sessions
Duration of each TENS sessions
Time frame: 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."
Time frame: Between osmotic dilator placement and dilation and evacuation procedure (approximately 16-24 hours)
Ease of use
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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."
Time frame: Between osmotic dilator placement and dilation and evacuation procedure (approximately 16-24 hours)
Analgesic use
Amount of ibuprofen taken and/or other analgesics
Time frame: Between osmotic dilator placement and dilation and evacuation procedure (approximately 16-24 hours)