Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management With Medication Abortion Through 70 Days' Gestation
NCT ID: NCT03925129
Last Updated: 2021-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2019-06-11
2020-03-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
TRIPLE
Study Groups
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TENS
high frequency TENS treatment
Treatment with high frequency for minimum of 1 hour after misoprostol administration
Sham TENS
Sham TENS treatment
Treatment with sham TENS device for minimum of 1 hour after misoprostol administration
Interventions
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high frequency TENS treatment
Treatment with high frequency for minimum of 1 hour after misoprostol administration
Sham TENS treatment
Treatment with sham TENS device for minimum of 1 hour after misoprostol administration
Eligibility Criteria
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Inclusion Criteria
* Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-SF)22 score \> 4
* Age equal to or greater than 18 years
* Provide informed consent to participate
* Willing to adhere to study procedures, including access to a smart phone, ability to receive text messages and answer online surveys on smart phone
Exclusion Criteria
* Allergy to mifepristone or misoprostol
* Contraindication or allergy to ibuprofen
* History of cardiac arrhythmia
* Presence of an implantable device with electrical discharge, i.e. cardiac pacemaker
* History of chronic pain disorder
* Any opioid use during previous 30 days
* Current or prior use of TENS
* BMI \> 30
18 Years
FEMALE
Yes
Sponsors
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Planned Parenthood of Greater New York
OTHER
Responsible Party
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Principal Investigators
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Ariella Goldman, MD
Role: PRINCIPAL_INVESTIGATOR
Planned Parenthood of Greater New York
Locations
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Planned Parenthood of New York City - Margaret Sanger Center
New York, New York, United States
Countries
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References
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Goldman AR, Porsch L, Hintermeister A, Dragoman M. Transcutaneous Electrical Nerve Stimulation to Reduce Pain With Medication Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jan 1;137(1):100-107. doi: 10.1097/AOG.0000000000004208.
Other Identifiers
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TENS MAB
Identifier Type: -
Identifier Source: org_study_id
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