TENS Unit To Decrease Pain After Laminaria Insertion

Description

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.

Conditions

Second Trimester Abortion

Study Overview

Study Details

Study overview

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.

Randomized Controlled Trial: TENS Unit To Decrease Pain After Laminaria Insertion

TENS Unit To Decrease Pain After Laminaria Insertion

Condition
Second Trimester Abortion
Intervention / Treatment

-

Contacts and Locations

Honolulu

1380 Lusitana St. Ste 1004, Honolulu, Hawaii, United States, 96813

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Queen's Medical Center,

Melissa Natavio, MD, MPH, STUDY_DIRECTOR, Complex Family Planning, The Queens Medical Center, Department of Obstetrics, Gynecology, and Womens Health

Study Record Dates

2025-05