Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Reduction During Intrauterine Device (IUD) Insertion in Outpatient Gynecology
NCT ID: NCT06335823
Last Updated: 2025-02-11
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
60 participants
INTERVENTIONAL
2024-06-05
2025-02-07
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
PREVENTION
DOUBLE
Study Groups
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Active TENS unit
All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients in this arm will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.
Transcutaneous electrical nerve stimulation (TENS)
All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit turned on and half will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.
Non-active TENS unit
All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will not have the TENS unit turned on.
Placebo Transcutaneous electrical nerve stimulation (TENS)
All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit will not be turned on.
Interventions
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Transcutaneous electrical nerve stimulation (TENS)
All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit turned on and half will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.
Placebo Transcutaneous electrical nerve stimulation (TENS)
All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit will not be turned on.
Eligibility Criteria
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Inclusion Criteria
* Individuals with a cervix and uterus
* Seeking intrauterine device (IUD) placement for contraception or management of abnormal uterine bleeding
* Meet medical eligibility for IUD placement
* Ability to consent in English
* Ability to use the visual analogue scale (VAS)
Exclusion Criteria
* Use of analgesics within the last 4 hours prior to IUD placement
* Presence of a pacemaker
18 Years
45 Years
FEMALE
Yes
Sponsors
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University Hospitals Cleveland Medical Center
OTHER
Responsible Party
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Jean Marino
APRN-CNP
Principal Investigators
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Jean M Marino, APRN-CNP
Role: PRINCIPAL_INVESTIGATOR
University Hospitals
Locations
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University Hospitals
Cleveland, Ohio, United States
Countries
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Other Identifiers
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STUDY20231621
Identifier Type: -
Identifier Source: org_study_id
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