COMPLETED

TENS Unit To Decrease Pain After Laminaria Insertion

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-08-14
Study Completion:2025-11-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06529003

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients undergoing laminaria insertion for D\&E procedure
  2. * Age 18 years or older
  3. * Capability and willingness to send and receive SMS messages by phone and complete web-based surveys
  4. * Capability to read and understand directions for using a TENS unit
  5. * Capability to operate a TENS unit according to provided directions
  1. * Inability to complete the informed consent in English
  2. * Exposure to adjunctive pharmacologic cervical preparation (misoprostol or mifepristone) within 48 hours of the D\&E procedure
  3. * Contraindication to ibuprofen or bupivacaine
  4. * Contraindication to TENS, including cardiac pacemakers, epilepsy, bleeding disorders, cancer, and concurrent use near transdermal drug delivery systems
  5. * Previous participation in this trial
  6. * Prior use of TENS unit

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-14
Study Completion Date2025-11-05

Study Record Updates

Study Start Date2024-08-14
Study Completion Date2025-11-05

Terms related to this study

Additional Relevant MeSH Terms

  • Second Trimester Abortion