Status:
COMPLETED
TENS Unit To Decrease Pain After Laminaria Insertion
Lead Sponsor:
Queen's Medical Center
Collaborating Sponsors:
University of Hawaii Foundation
Conditions:
Second Trimester Abortion
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 f...
Detailed Description
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 a...
Eligibility Criteria
Inclusion
- Patients undergoing laminaria insertion for D\&E procedure
- 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
- Inability to complete the informed consent in English
- 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
Key Trial Info
Start Date :
August 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 5 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06529003
Start Date
August 14 2024
End Date
November 5 2025
Last Update
December 16 2025
Active Locations (1)
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1
1380 Lusitana St. Ste 1004
Honolulu, Hawaii, United States, 96813