RECRUITING

Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Control

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Conditions

Transcutaneous Electric Nerve StimulationAnalgesiaCesarean SectionTENSCesarean analgesia

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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

Purpose of study is to evaluate the efficacy of transcutaneous electrical nerve stimulation (TENS) for post-operative pain control after a cesarean delivery compared to placebo and no TENS.

Official Title

Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Control

Quick Facts

Study Start:2020-01-29
Study Completion:2021-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04399707

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:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Non-English speaking
  2. * Subjects with a history of chronic pain or chronic opioid use
  3. * Pre-operative use of opioids for more than 1 week in the preceding 6 months
  4. * Previous exposure to the TENS unit
  5. * Women with an allergy or contraindication to narcotics/NSAIDs/acetaminophen
  6. * Subjects who had a midline vertical skin incision during this operation
  7. * Subjects who did not receive intrathecal opioids at the time of their cesarean delivery
  8. * Adhesive allergies
  9. * Subjects with a pacemaker (due to the unknown effects of the TENS on the electrical activity of the heart)
  10. * Intraoperative general anesthesia
  11. * Inability to consent to the study
  12. * Postpartum tubal ligation

Contacts and Locations

Study Contact

Nicole Kurata
CONTACT
(808)577-3344
nkurata@hawaii.edu
Kelly Yamasato
CONTACT
kyamasat@hawaii.edu

Principal Investigator

Kelly Yamasato
PRINCIPAL_INVESTIGATOR
Physician

Study Locations (Sites)

Nicole Kurata
Honolulu, Hawaii, 96826
United States

Collaborators and Investigators

Sponsor: Hawaii Pacific Health

  • Kelly Yamasato, PRINCIPAL_INVESTIGATOR, Physician

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 Date2020-01-29
Study Completion Date2021-05

Study Record Updates

Study Start Date2020-01-29
Study Completion Date2021-05

Terms related to this study

Keywords Provided by Researchers

  • TENS
  • Transcutaneous electric nerve stimulation
  • Cesarean analgesia

Additional Relevant MeSH Terms

  • Transcutaneous Electric Nerve Stimulation
  • Analgesia
  • Cesarean Section