Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2024-08-14
2025-11-05
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Placebo
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.
TENS unit
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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University of Hawaii Foundation
UNKNOWN
Queen's Medical Center
OTHER
Responsible Party
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Principal Investigators
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Melissa Natavio, MD, MPH
Role: STUDY_DIRECTOR
Complex Family Planning, The Queens Medical Center, Department of Obstetrics, Gynecology, and Womens Health
Locations
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1380 Lusitana St. Ste 1004
Honolulu, Hawaii, United States
Countries
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Other Identifiers
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RA-2024-018
Identifier Type: -
Identifier Source: org_study_id