Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Control During First Trimester Abortion
NCT ID: NCT03187002
Last Updated: 2020-11-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
109 participants
INTERVENTIONAL
2018-01-18
2019-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Transcutaneous electrical nerve stimulation (TENS)
Transcutaneous electrical nerve stimulation (TENS)
Transcutaneous electrical nerve stimulation (TENS)
Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders.
SHAM: Moderate IV Sedation
Sham IV to ensure blinding
Moderate IV Sedation
Fentanyl, versed
Moderate IV Sedation
IV sedation with fentanyl and versed
SHAM: Transcutaneous electrical nerve stimulation (TENS)
Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding
Interventions
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Transcutaneous electrical nerve stimulation (TENS)
Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders.
Moderate IV Sedation
IV sedation with fentanyl and versed
SHAM: Transcutaneous electrical nerve stimulation (TENS)
Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding
SHAM: Moderate IV Sedation
Sham IV to ensure blinding
Eligibility Criteria
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Inclusion Criteria
* Gestational age \<12 weeks
* \< 18 years of age
* Agrees to be randomized
Exclusion Criteria
* \> 18 years of age
* Fetal demise
* Pre-procedure use of misoprostol
* No means of transportation following procedure
18 Years
FEMALE
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Principal Investigators
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Principal Investigator, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Planned Parenthood Mar Monte
San Jose, California, United States
Countries
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References
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Lerma K, Goldthwaite LM, Blumenthal PD, Shaw KA. Transcutaneous Electrical Nerve Stimulation for Pain Management of Aspiration Abortion up to 83 Days of Gestation: A Randomized Controlled Trial. Obstet Gynecol. 2021 Sep 1;138(3):417-425. doi: 10.1097/AOG.0000000000004502.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IRB-41589
Identifier Type: -
Identifier Source: org_study_id